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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_574_Библиотеки_им_академика_М_И_Перельмана.pdf
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performed aprospective, randomized multicenterstudy to evaluate closed reductionand immobilizationwith and withoutcalcium phosphate cement (Norian SRS)inthe management of distal radial fractures(33). Atotal of 323
patients with adistal radial fracture were randomized to a treatment groupconsisting of aclosed reduction and Norian SRS, and acontrol groupconsisting of aclosed reduction and application of acast or external fixator.Inthe treatment group, wrist motion was encouraged beginning two weeks postopera­tively while in thecontrol group,the fixatororcastwas continued for six to eight weeks. Significant clinical differences were seen at six and eight weeks postoperatively resulting in better grip strength, wrist range of motion, digital motion, use of thehand, andsocial andemotionalfunction, with less swelling in the patients treated with Norian SRS than in the control group.Bythree months,there werenosignificant differences except for digital motion, which remained signi­ficantly better in the group treatedwith Norian SRS. At one year,noclinical differences weredetected. Radiographically at sixtoeight weeks, both groups wereequivalentwith the exception of the change in ulnar variance, which was higher in the treatment group(2.2 mm compared with 1.5 mm) (33). Similar results were reported by Kopylov et al. in arandomized study on failed conservative treatment of distal radius fractures or redisplaced distal radius fractures (34). The study compared calcium phosphate cement followedbycast immobilization with external fixator alone.
Sanchez-Sotelo et al. performed aprospective, randomized study on 110patients older than 50 years with distal radius fractures to compare the outcome of conservative treatment to implantation of moldable bone cement and immobilization in a cast for two weeks (35). The authors reported that patients treated with Norian SRS had less pain and earlier restoration of movement andgripstrength.Satisfactoryresults were demonstrated in 82% of the Norian SRS patients and 55% of the control group. The rates of malunion were 18% and 42%, respectively.Soft-tissue extrusion was present initially in 69% of the Norian SRS patients decreasing to 33% at one year.
Zimmermann et al. performed aprospective study on 52 menopausal, osteoporotic women with unstable intra-articular distal radius fractures to compare the outcome of percutaneous pinning and immobilization in acast for six weeks to the use of injectable calciumphosphate bone cement (NorianSRS)to supplement pin and screw fixation with immobilization in a cast for three weeks (36). All patients were reviewed on average twoyears (range 21–29 months)after surgery. Theauthors reported that patientstreatedwith Norian SRShad better functionaloutcome,restorationofmovement, and grip strength. In the treatment group, there was a1-mm loss of radial length, a38 loss of radial inclination and a78 loss of palmar tilt. In the control group, the radial length decreased by 3mm, radial inclination decreased by 118 ,and palmar tilts by 128 .Loss of reduction was significantly higher in the control group comparedwith the treatment group.
In apreliminary report, Jupiter et al. reported their results on the percutaneous use of injectable calcium phosphate cement (Norian SRS) in five patients with distal radius fracture (29). The purpose of the study was to evaluate the feasibility of Norian SRS bone cement injected percutaneously into adistal radius following reduction in preventing loss of reduction as well as safety.All fractures werereduced under regional or general anesthesia and the cement was introduced via acatheter system into the metaphyseal defect of the fracture. Ashort arm cast was applied and remained in place for six weeks. Prospec­tive follow-up at 12 months showed an average loss of ! 1mm; radial anglemaintainedatanaverage of 25.48 ;and volar anglewas within the normalrange (0–21 8 )infour patients whileone patienthad adorsalangle of 7 8 .Wrist motion improved 50%betweensix weeksand threemonthsand improved further by 12 months when grip strength reached a
FIGURE 2 Clinical photograph of ahemodialysis patient who sustained adistal radius fracture in the ispilateralwrist. Source:Courtesy of Virak Tan, MD.
FIGURE 3 Reduction of the articular depression with an elevator placed through the cortical window at the radial styloid. Source:Courtesy of Virak Tan, MD.
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Azad et al.
mean of 88%ofthe contralateralside. Dorsaland volar extrusion of injectedcement in four patientsresorbed over time. There were no clinically significant adverse effects or complications. The authors concluded that cement proved to be clinically safe and effective as acancellous bone cement to maintain fracturereduction of unstable extra-articular distal radius fractures.
In an unpublished series, Paige (37) augmented 15 patients whounderwentinternalfixation of unstable distal radial fractureswith injectable calciumsulfate bone graftdue to dorsalfragmentation and an associatedmetaphysealbone void.All patients had prospectiveevaluation using the patient-rated wrist evaluation (PRWE) form at aminimum of 3monthsand againat6and 12 months afterfixation. The fractures united within 6to12weeks with restoration of anatomical positioninahigh percentage. The return to functional activities was highlighted by improvement in the PRWE Scores. In summary,the author concluded that volar
locking platefixation maybenefitfor bone graftsubstitute augmentation for the morecomplex, unstable fracturepatterns.
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Bone Lesions
Injectable ceramic bone cements provide asuitable bone-filling material for cystic lesions since it can be used with minimal trauma to the thin cortical shell around the lesions and also provides immediate structural support.
Few clinical studies exist regarding the use of injectable calcium phosphate bone cements in the management of bone lesions. Joosten et al. reportedaone-year prospective study of eight patients with enchondroma whoweretreatedwith calcium phosphate cement (BoneSource, Howmedica, Ruther­ford,New Jersey,U.S.A.) without fixation (38). All patients had afull functional recoverywithout any complications. In another study,Yasuda et al. reported10patients with digital enchon­droma (six proximal phalanges, two middle phalanges, and two
FIGURE 4 MICRONAIL fixation. Source:Courtesy of Virak Tan, MD.
FIGURE 5 Calcium phosphate bone graft substitute cement was injected percutaneously into the metaphyseal
defect. The cement appears as aradiodense material on fluoroscopic images. Source:Courtesy of Virak Tan, MD.
The Role of Bone Graft Substitutes
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metacarpal bones) treated with an injectable calcium phosphate bone cement aftercurettage of thelesions through asmall cortical window (39). No postoperative splint was used and only abulky dressing was applied. One week after surgery, range of motion exercises werestarted. Serial radiographs were used to evaluate bony incorporation and absorption of cement. Incorporationofcement(defined by authorsasaseamless change of radiographic appearance and no gap between cancel­lous bone and cement) occurred at an average of 4.5 months (range 3–6.1 months) after surgery.All patients had full range of motion aftersurgery.All butone patientreturnedtotheir ordinary daily activities within four weeks of surgery (39).
In another study,Gaasbeek et al. reported their results with use of plaster of Paris in 19 enchondromas of foot and hand in 19 patients.After thorough curettage of enchondroma lesions, sterile plaster of Paris tablets wereused to fill the cavities. After amean follow-up of 53 months (range 15–139 months), the mean functional Musculoskeletal Tu mor Society Score was reported as 29.1 points (97%; range 28–30) and no local recur­rence was seen. The authors concluded that plaster of Paris appearssafeand effective as abone-fillingsubstance after curettageofenchondroma (40).
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SUMMARY
Ceramic-based synthetic bone graft substitutes, which include calciumphosphateand calciumsulfate,haveundergone
significant development in the past decade. These bone graft substitutes offer several distinct advantages over autograft and other groups of bone graft substitutes. Though autograft is still thegoldstandard in bone grafting, significant number of disadvantages exists. The ceramic cements fulfill many of the requirements of an ideal bone graftyet overcome several disadvantages of autograft as well. Because autologous bone does not need to be harvested, by definition these bioceramic substitutes are “minimally invasive.”
In recent years, minimally invasive technologies and tech­niques have revolutionized many typesofsurgeries.The injectable calciumphosphate and calciumsulfate-based ceramic bone graft substitutes are one more addition to the armamentariumofminimallyinvasive orthopedic surgery. Injectable cements are generally used as an adjunct to internal fixation for the treatment of fracturesorasbone void fillers. The cements harden endothermically which limits tissue damage while developing acompressive strength intermediate between cortical and cancellous bone.
Anumber of studies have been done to evaluate injectable cements in clinical situations including trauma such as distal radius fractures, tibial plateau fractures, calcaneous fractures, and vertebroplasty,and benign bone lesions such as enchon­dromas.However,furtherstudies needtobeconducted to evaluate theroleofinjectablecalcium sulfate andcalcium phosphate cements in the management of bone cysts in the hand and forearm. As new data from preclinical and clinical studies accumulate, the clinical uses of these bone graft substi­tutes will be expanded and enhanced.
Most studies in general have shown positive results with the use of these substitutes. However,disadvantages do exist for these bone graft substitutes. The cements are known to lack osteogenic or osteoinductive potential and exhibit poor strength under sheer stress. Inflammatory reactions to loose bodies in the joints can complicate their use in asmall percentage of patients. Besides these clinical limitations, one practical pitfall which preventstheir widespread use is the high cost of injectable cements.
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SUMMATION POINTS
Indications
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Distal radius fractureswith metaphyseal comminution
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Simple bone cysts
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Aneurysmal bone cysts
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Enchondromas
Outcomes
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Less pain
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Earlier restoration of movement and grip strength
Disadvantages
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Lack osteogenic or osteoinductive potential
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Poor strength under sheer stress
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Extrusion into soft_tissue and joint space may cause inflam­matory reactions in asmall percentageofpatients
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High cost
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REFERENCES
1. Kahn B. Superior gluteal artery laceration,acomplication of iliac bone graft surgery.Clin Orthop Relat Res 1979; 140:204–7.
FIGURE 6 Apostoperative clinical photograph showing the incisions for the minimally invasive techniques of distal radius fracture fixation and bone substitute cement placement. There is minimal swelling in the wrist even in this early postoperative time. Source:Courtesy of Virak Tan, MD.
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2. Lotem M, Maor P, HaimoffH,etal. Lumbar hernia at an iliac bone graft donor site. Acase report. Clin Orthop Relat Res 1971; 80:130–2.
3. Fowler BL, Dall BE, Rowe DE. Complications associated with harvesting autogenous iliac bone graft. Am JOrthop 1995; 24(12):895–903.
4. Gupta AR. Perioperative and long-term complications of iliac crest bone graft harvesting for spinal surgery: aquantitative review of the literature. Int Med J2001; 8(3):163–6.
5. Kurz LT,Garfin SR, Booth RE, Jr.Harvesting autogenous iliac bone grafts. Areview of complications and techniques.Spine 1989; 14(12):1324–31.
6. Arrington ED, Smith, WJ, Chambers,HG, et al. Complications of iliac crest bone graft harvesting. Clin Orthop Relat Res 1996; 329:300–9.
7. Kuhne JH, Bartl R, Frisch B, et al. Bone formation in coralline hydroxyapatite.Eff ects of pore size studied in rabbits. Acta Orthop Scand 1994; 65(3):246–52.
8. Eggli PS, Muller W, Schenk RK. Porous hydroxyapatite and tricalcium phosphate cylinderswith two different pore size ranges implanted in the cancellous bone of rabbits. Acomparative histomorphometric and histologic study of bony ingrowth and implant substitution. Clin Orthop Relat Res 1988; 232:127–38.
9. Nakahara H, GoldbergVM, Caplan AI. Culture-expanded perio­steal-derived cells exhibit osteochondrogenic potential in porous calcium phosphate ceramics in vivo. Clin Orthop Relat Res 1992; 276:291–8.
10. Klein CP,Driessen AA, de Groot K, et al. Biodegradation behavior of various calcium phosphate materials in bone tissue. JBiomed Mater Res 1983; 17(5):769–84.
11.Frayssinet P, TrouilletJL, Rouquet N, et al. Osseointegration of
macroporous calcium phosphate ceramics having adifferent chemical composition. Biomaterials 1993; 14(6):423–9.
12. Termine JD, PeckauskasRA, Posner AS. Calcium phosphate formation in vitro. II. Effects of environment on amorphous–crystal­line transformation. ArchBiochem Biophys 1970; 140(2):318–25.
13. Laurencin CT,ed. Bone Graft Substitutes. West Conshohocken: ASTM International, 2003:281–99.
14. Wiltfang J, Merten HA, Schlegel KA, et al. Degradationcharac­teristics of alpha and beta tri-calcium-phosphate (TCP) in minipigs. JBiomed Mater Res 2002; 63(2):115–21.
15. Brown, WaC, LC, Dental restorative cement pastes. American Dental Association Health Foundation: U.S. 1985.
16. Takagi S, Chow LC. Formation of macroporesincalcium phos­phate cement implants. JMater Sci Mater Med 2001; 12(2):135–9.
17. Welch RD, Zhang H, Bronson DG. Experimentaltibial plateau fractures augmented with calcium phosphate cement or autolo­gous bone graft. JBone Joint Surg Am 2003; 85-A(2):222–31.
18. Sarkar MR, Wa chter N, Palka P, et al. First histological observations on the incorporation of anovel calcium phosphate bone substitute material in human cancellous bone. JBiomed Mater Res 2001; 58(3):329–34.
19. Dressmann H. Ueber knochenplombierung bei hohlenformigen defekten des knochens. Beitr Klin Chir 1892; 9:804–10.
20. Peltier LF.The use of plaster of paris to fill large defects in bone. Am JSurg 1959; 97(3):311–5.
21. Peltier LF,Jones RH. Treatment of unicameral bone cysts by curettage and packing with plaster-of-Paris pellets. JBone Joint Surg Am 1978; 60(6):820–2.
22. Pietrzak WS ,Ronk R. Calcium sulfate bone void filler: areviewand a look ahead. JCraniofac Surg 2000; 11(4):327–33 (discussion 334).
23. Bucholz RW.Nonallograft osteoconductive bone graft substitutes. Clin Orthop Relat Res 2002; 395:44–52.
24. Damien CJ, Parsons JR. Bone graft and bone graft substitutes: a review of current technology and applications.JAppl Biomater 1991; 2(3):187–208.
25. Rosenblum SF,Frenkel S, Ricci JR, et al. Diffusion of fibroblast growth factor from aplaster of Paris carrier.JAppl Biomater 1993; 4(1):67–72.
26. Cesari C, Gatto MR, MalucclliF,etal. Periodontal growth factors and tissue carriers: biocompatibility and mitogenic efficacy in vitro. JBiomed Mater Res BAppl Biomater 2006; 76(1):15–25.
27. Constantz BR, Ison IC, Fulmer MT,etal. Skeletal repair by in situ formation of the mineral phase of bone. Science 1995; 267(5205):1796–9.
28. Kopylov P, Jonsson K, Thorngren KG, et al. Injectable calcium phosphate in the treatment of distal radial fractures. JHand Surg [Br] 1996; 21(6):768–71.
29. Jupiter JB, Wi nters S, Sigman S, et al. Repair of five distal radius fractures with an investigational cancellous bone cement: apre­liminary report. JOrthop Tr auma 1997; 11 (2):110–6.
30. Lobenhoffer P, Gerich T, Witte F, et al. Use of an injectable calcium phosphate bone cement in the treatment of tibial plateau fractures: aprospective study of twenty-six cases with twenty-month mean follow-up. JOrthop Tr auma 2002; 16(3):143–9.
31. FlautreB,Delecourt C, Blary MC, et al. Volume effect on biological properties of acalcium phosphate hydraulic cement: experimental study in sheep. Bone 1999; 25(Suppl.2):35S–9.
32. Robinson D, Alk D, Sandbank J, et al. Inflammatory reactions associated with acalcium sulfate bone substitute.Ann Tr ansplant 1999; 4(3–4):91–7.
33. Cassidy C, Jupiter JB, Cohen M, et al. Norian SRS cement compared with conventional fixation in distal radial fractures. A randomized study.JBone Joint Surg Am 2003; 85-A(11):2127–37.
34. Kopylov P, Runnqvist K, Jonsson K, et al. Norian SRS versus external fixation in redisplaceddistal radial fractures. Arandom­ized study in 40 patients. Acta Orthop Scand 1999; 70(1):1–5.
35. Sanchez-Sotelo J, Munuera L, Madero R. Treatment of fractures of the distal radius with aremodellablebone cement: aprospective, randomised study using Norian SRS. JBone Joint SurgBr2000; 82(6):856–63.
36. Zimmermann R, Gabl M, Lutz M, et al. Injectable calcium phos­phate bone cement Norian SRS for the treatment of intra-articular compression fractures of the distal radius in osteoporotic women. Arch Orthop Trauma Surg 2003; 123(1):22–7.
37. Joosten U, Joist A, Frebel T. The use of an in situ curing hydroxyapatite cement as an alternative to bone graft following removal of enchondroma of the hand. JHand Surg[Br] 2000; 25(3):288–91.
38. Paige R. Distal radial fractureaugmentation with injec­table bone graft sustitute—The Geelong Experience.2006: Melbourne,Australia (personal communications).
39. Yasuda M, Masada K, TakeuchiE.Treatment of enchondroma of the hand with injectable calcium phosphate bone cement. JHand Surg[Am] 2006; 31(1):98–102.
40. Gaasbeek RD, RijnbergWJ, van Loon CJ, et al. No local recurrence of enchondroma after curettage and plaster filling. Arch Orthop Trauma Surg2005; 125(1):42–5.
The Role of Bone Graft Substitutes
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4
Bioabsorbable Implants in Hand and Wrist Surgery
Mark L. Kavanagh, Regis L. Renard, and John T. Capo
Department of Orthopedics, The New Jersey Medical School, University of Medicine and DentistryofNew Jersey, Newark, New Jersey, U.S.A.
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INTRODUCTION
Metal implant devices have along, reliable clinical history, are relatively cheap, and easy to produce and shape. These implants used in hand and wrist surgery alsohave their disadvantages. Largedifferences between Young’s moduli of the implants and bone often lead to stress shielding resulting in osteopenia which may result in pathologic fractures (1). In addition, elevated stress concentration at the junction of the implants andthe host bone may result in periprosthetic fractures. Implantation of metallicdevices oftenrequires significantsofttissue strippingwhich reducesthe local bloodsupplyabout theimplant.Thiseffectisconstant during theentiretime the implant is in place. Metallic devices also have the potential for corrosion and wear and debris formation with subsequent metallosis (2). Prominent or protruding metallic hardware may interfere with surrounding tissues that disturb joint movement, tendon gliding, or even cause tendon ruptures resulting in pain and loss of function. This effect is particularly important around the hand and wrist. Often times these implants need to be removed. Stern et al. (3) and Berman et al. (2) have reported aneed for plate removalin25% of casesofmetacarpaland proximal phalangeal fractures.
An ideal implant would ensure adequate bone fixation, transfer increasing load to bone, not affect skeletal growth, and need notberemoved.Bioresorbableimplants canavoid problems associatedwith metal implants,suchasstress shielding, corrosion, wear and debris formation, and the need for implant removal (4).
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EVOLUTION OF IMPLANTS
During thelastfew decades, theinterestinsafe, reliable resorbable implants has steadily increased. The first application of this technology came with the use of bioresorbable polymers in sutures, such as Dexon (US Surgical,Norwalk, Connecticut, U.S.A.) and Vicryl (Ethicon, Somerville, New Jersey,U.S.A.). Thereare nowresorbableimplants designedfor trauma surgery,including pins, screws, plates, dowels, anchors, and membranes. Bioresorbable implants must meet several biologi­caland technicalrequirements(4).Theymust notinduce adverse inflammatory or foreignbody reactions. The implants must not be carcinogenic, mutagenic, or teratogenic, must not cause allergic,hypersensitive,ortoxic responses, and must not activate the complement system (5). Resorbable implants need to maintain adequate mechanical properties in vivo for the desired time and degrade at an effective rate required for bone healing. Mechanical properties aredeterminedbythe con­ditions of polymer synthesis, the processing of materials into implants, and by the sterilization process of implants.
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IMPLANT PROPERTIES
Degradation of implants manifest as implant fragmentation, strength loss, and reduction of polymer molecular weight (6–9). Degradationofthese implantsinvivo proceedsvia abulk hydrolysis of ester bondsthat arepresent in the polymer chain. These materials degrade to monomeric acids and even­tually to carbon dioxide and water that are removed from the body via respiratory routes and kidneys during Krebscycle. Physical factors that affect tissue response to implants include implant shape, physical structure,mass of the implant, stress at the implantation site, and micromotion at the implant–tissue interface (4). Clinically large bulky implants with fast degrading polymerscan causealarger inflammatory reaction when compared with smallerimplantswithslowlydegrading polymers.
The earliest resorbable implants weremade from poly­glycolic acid (PGA), but this material is relatively hydrophilic and highly crystalline and will degrade and lose its strength very rapidly in thebody. It may alsogiverisetofluid accumulation and sterile sinus formation. This material is no longer used in orthopedic fixation devices.
Today,copolymerization can be used to create implants with different ratios of monomers (
D and L monomers) to alter
the chemical and physical properties (4,10). The
L isomer of
polylactide (PLLA) is the material found in most orthopedic implants used today.This isomer has ahigh degree of crystal­linity andismoreresistant to hydrolysis.Apure PLLA remains detectable forbetween18monthsand 4years in vivo. The
D isomer (PDLLA) is amorphous and provides
less tensile strength. It promotes resorption of the implants over alonger period of time. Currently, bioabsorbable implants are available in avariety of plates, screws,and smooth pins (Figs. 1–3).
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PROCESSING AND STERILIZATION
Self-reinforcing (SR) manufacturing technique enablesthe processingofbioabsorbable polymers into high strength, high-modulus implants (9,11–13). Ahigh degree of molecular orientation makes the self-reinforced implants stiffand strong in the direction of their long axis, which increasesthe mechan­ical strength, modulus, and toughness of theimplants. The bending modulus of SR devices is close to that of cortical bone (10–17GPa), whichisimportantfor bone healing (12,14,15).The high bendingmodulus of metallic implants (100–250 GPa) leads to stress shielding in the bone in loaded areas (13). SR implants also have better handling properties. SR plates can be bent with pliers to conform to the bone at room temperaturewithout significant loss of strength.
Problems can occur with sterilization of these implants (16,17). High-energy irradiation causes extensive degradation and loss of mechanical properties. Ethylene oxide sterilization does not practically affect mechanical and molecular properties of theimplantsbut thereare concernsabout residuesand environmental problems (17). Newer sterilization techniques now include the use of gamma irradiation due to the potential risks of toxic residues remaining after ethylene oxide steriliza­tion (16).
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EXPERIMENTAL STUDIES
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Animal Investigations
Viljanen et al. (14) studied the changes that occur in bones after experimental osteotomies werefixed with absorbable 4.5­mm SR-PLLA screwsand 4.5-mm metallic screwsthe distal femur in rabbits. They found that at 36 weeks, there was a significantlyincreased amountofexternal calluswith themetallic fixation groupwhencomparedwiththe SR-PLLA group. However,cortical bone mineral density was decreased in the metallic fixation group at both 6and 36 weeks. Magnetic resonanceimagings showed edema surrounding the screws in both groups, however,the size of theedematouszones wassignificantlydecreasedinthe SR-PLLA group. The authors felt that the SR-PLLA fixation method resulted in morerapid and improved healing due to the physiologic elasticity of these implants when compared with the metal screws. The resorbable implants appeared to prevent stress protection atrophy and weakening of the fixed bone secondary to osteoporosis.
Joukainen et al. (11) studied the strength retention of 2.0­mm SR-PLA70/30 rodsand fixationpropertiesofthese implants in rat distal femur osteotomies. In addition, 70 absorb­able rods wereimplanted into the dorsal subcutaneous tissue of 16 rats and three point bending and shear tests wereperformed after these animals were killed. At 52 weeks, the shear strength and flexural modulus was 41% of their initial value and the flexural strength was 43% of its initial value. Osteotomies in the distal femur werefixed with rods in 39 rats. Macroscopic and X-ray analysis showed that 23 out of 32 subjects (72%) have solid union at the osteotomy site. These authors felt that the mechanical strength and fixation properties of the resorbable rods were adequate for fixation of osteotomies in cancellous bone in rats.
FIGURE 1 Two different sized plates and abioresorbable screw from the ReUnite e set(EBI, Parisippany,New Jersey,U.S.A.).These implants are manufactured from acopolymer of 82%
L -lactic acid and
18% glycolic acid. Source:Courtesy of John T. Capo, MD.
FIGURE 2 AReUnite screw and smooth pin. The screw head attach­ment is seen. This hex-shapedend fits into the screwdriver and is sheared offwhen the screw is fully seated. Source:Courtesy of John T. Capo, MD.
FIGURE 3 The ReUnite set contains avariety of metal drill bits, taps, implant insertion instruments, and depth gauges.
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Kavanaghetal.
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Human Investigations
Pihlajamaki et al. (18) examined the use of SR-PLLA absorb­able pins in thefixation of fractures and osteotomies in humans. They reviewed 27 patients with fractures or osteo­tomies that were treatedwith internal fixationusing bioabsorbable pins.Patientshad smallfragmentfractures and osteotomies of the hand, foot, elbow,and patella. The authors used 1.5- or 2.0-mm cylindrical rods composed of SR-PLLA. There werenowound infections or inflammatory foreignbody reactions noted. No redisplacement occurred in any of the patients and the materials were absorbed within two years. Computed tomography scans wereobtained in three patients at 15 and 37 months and showed that the pins werenolonger visible but no new bone had formed within the drilled channels.
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INDICATIONS
Although the literature has yet to clearly elucidate definitive indications for the use of bioabsorbable implants, there are specific timeswhenthe use of theseimplants canbe beneficial. In the hand and wrist, there is little soft tissue coverage andthe use of abulky metalimplant canbe problematic. Using resorbable implants in these cases could be advantageous to minimize final hardware prominence and to avoid asecond operation to remove these implants (1,3,19–26). When metal implants are removed, unfilled holes can provide astress riser for afracture. As bioabsorbable implants slowly degrade, the surrounding bone is able to fill in such defects.
The use of metal implants around the tendons and joints in the hands and wrist can also pose potential problems. Bior­esorbable implants pose less of aproblem with encroachment on atendon or the joint capsule. If asmall portion of the implant is within the joint or impinging on atendon, this difficulty will be alleviated as the implant resorbs.
There are also other times in which abioabsorbable implant is notanappropriate choice. If thepatienthas an active infection, the use of any type of implant should be avoided as this would provideanidus for persistent infection. At this point in time, complex articular fractures that need rigid fixation in order to prevent displacement and to ensure anatomic articular alignment, should be fixed with the more traditional metal implants (5).
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SPECIFIC IMPLANTS USED IN FIXATION OF FRACTURES
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Metacarpal Shaft Fractures
Surgical Technique
The typical injury is usually adisplaced index or middle finger metacarpal fracture in aslender and young individual (Fig. 4). Anesthesia can be performed locally,via regional blockade, or general anesthesia as per surgeon preference. The hand is prepped and draped in standard fashion. A longitudinal dorsal incision should be made over the meta­carpal fracturesite. The extensor tendon is protected and retracted and the juncturae tendinae are divided if necessary. Theoverlying periosteum and interosseusmuscle are elevated as aflap. The fracture surfaces are identified and fracture ends prepared in standard fashion(Fig. 5A). To improve fracture stability while still keeping the hardware low-profile, we often prefer to place ametal interfragmentary screw first (Fig. 5B). This also makes placement of the plate
much easier.Abioabsorbable plate is applied dorsally to the tension side of the metacarpal. The ReUnitee (EBI, Parisip­pany,New Jersey,U.S.A.) sethas malleabletemplates availabletosizeand assess the contour of the necessary plate (Fig. 6). The screw holes are drilled and the threads are tapped with metal instruments. The bioabsorbable screws are individually wrapped sterile and come attached to an insertion rod fixed to the head. They are inserted with the appropriate screw driver and the insertion rodissheared off
(A)
(B)
FIGURE 4 ( A )Anterior–posterior radiographdemonstrating asecond metacarpal shaft fracture with shortening and displacement. ( B )Lateral view shows unacceptable angulation of the fracture. Source: Courtesy of John T. Capo, MD.
Bioabsorbable Implants in Hand and Wrist Surgery
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21
as the screw is seated (Fig. 7). The final few turns typically achieve asolid bite, but care must be taken not to overtighten the screws as the head can be sheared off. The heads may be flattened somewhat with an electrocaughteryinstrument included in the set that melts the material. The periosteum and muscle fascia are closed over the plates to avoid any early tendon impingement (Fig. 8).
Outcomes
Waris et al. (22) compared bioabsorbable miniplating versus metallic fixation for metacarpal fractures, using fresh frozen second metacarpals from cadavers. He tested threepoint bendingand torsional loadingafter transverse osteotomies were fixed with avariety of methods, includingSR-PLLA­PGA80/20 plating, SR-poly-
L / DL-lactide 70/30plating,
(A)
(B)
FIGURE 5 ( A )Exposure of amid-shaft second metacarpal fracturethroughalongitudinal incision. The periosteum and muscle fascia are elevated as aflap. The patient is a17-year-old boy andthisishis dominant hand. ( B )The fracture is first stabilized with atenaculum and then provisionallyfixedwit h1.3-mmtitanium screw in alag fashion. Source:Courtesyof John T. Capo, MD.
FIGURE 6 Atrialing template is placed over the dorsum of the metacarpal to approximate the length of theplaterequired. Source: Courtesy of John T. Capo, MD.
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titanium plating, and Kirschner (K)-wirefixation. In apex dorsal and palmar bending, dorsal SR-PLLA-PGA 80/20 plating, and SR-poly-
L / DL-lactide 70/30 plating providedstability com-
parable with dorsal titanium 1.7-mm plating. The rigidity and maximum bending moment of 2.0-mm dorsal bioabsorbable plates werehigher than those of K-wires. Overall, he found that low profile SR-PLLA-PGA and SR-poly-
L / DL-lactide miniplates
providesatisfactorybiomechanicalstability formetacarpal fixation.
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PHALANGEAL FRACTURES AND INTERPHALANGEAL JOINT ARTHRODESIS
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Surgical Technique
Fracture Fixation
The phalangeal fractures are reduced in astandard fashion and percutaneous pinning is typically performed. With most bioab­sorbable pins, ahole needs to be first drilled with ametallic pin. The resorbable rodisthenplacedintothistract with an insertion device. The insertion device pushes the rod along the hole drilled by the K-wire. This requires rigid stability of the fracturefragments to avoid malalignment of the K-wire path. This at times can be difficult. Recently anew resorbable pin, Trim-It Drill Pine (Acumed, Beaverton, Oregon, U.S.A.) has been introduced that avoids this. The pin has an attached metal tip that allows it to be drilled directly into the bone. The metal tip can be cut offonthe far side of the bone when possible or can be left on theinnerside of themedullarycanal to avoid migration.
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Arthrodesis
The distal interphalangeal joint is approached through adorsal Y- or H-type incision. The extensor tendon is divided and the collateralligamentsare elevated. The articular surfaces are removed with arongeur.Next, the intramedullary canals of the distal and proximal phalanxes are drilled utilizing adrill-bit that is 0.5-mm larger in diameter than the bioabsorbable rod. This is followed by reaming the canals to the size of the implant. The bioabsorbable rod is inserted anterograde into the distal phalanx medullary space. The distal phalanx and intramedullary placed rodisthenreduced to themiddle phalanx in aretrograde fashion. The extensor tendon, collateral ligaments, and skin are then sutured in standard fashion and the finger is splinted.
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Outcomes
Jensen and Jensen (26) investigated poly-p -dioxanone (PPD) pins in phalangeal fracture fixation, arthodesis, and osteotomies versus standard K-wires. Their case series compared 11 patients with biodegradable pindevices [fouropenreductionand internal fixation (ORIF), five arthrodeses, and two osteotomies] to 12 patients (three ORIF and nine arthrodeses)instrumented with K-wires followed over six months. In the fracture-fixation group, the authors reported an earlier return to normal range of motion usingthe resorbableimplants. Oneout of thefour patients with PPD pins required reoperation secondary to loss of fixation. Allofthe K-wire fracture fixationsrequired additional procedures for hardware removal.
Patients treated with PPD arthodeses had two failures of fusion (40%)and onerequiredre-fusion while thesecond received an amputation. This is greater than the frequency of failed fusions noted in the K-wire group (22%). One pin tract infection was noted in the PPD arthodesis group versus two pin tractinfectionsinthe K-wire group. Thirteenadditional procedures wereneeded to remove the K-wires. This study is promising, but it contains small patient numbers and had a follow-up time of only six months.
Interphalangeal jointarthrodesis utilizingPLLA rods was investigated by Arata and colleagues (27). This case series of 15 distal interphalangeal joints andone interphalangeal joint of thethumb hadafollowupoftwo to 25 months. Successful fusion was noted in all joints by eight weeks. Two patientsdevelopedpainlesslocalizedswelling. No cases of infection, nonunion,ordeformitywerenoted. Theauthors concluded that PLLA rods can be safely used for interphalan­geal fusions.
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SCAPHOID FRACTURES AND NONUNIONS
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Surgical Technique
The following surgical technique will focus on percutaneous fixation of scaphoid fracturesfromavolar approach. For more comminuted or displaced fractures, an open technique is more appropriate. The patient is positioned supine and the upper extremityisplaced on astandard handtable andamini­fluoroscopy machine is usedtovisualize the scaphoid. The wrist is placed over asmall towel bump to induce wrist extension.The volarretrograde approachisour preferred entrysite forpercutaneousfixationofscaphoidfractures.
FIGURE 7 The resorbable implant is placed dorsally and fixed proximally and distally with twoscrews. Sou rce :Cou rt esyofJohnT. Capo, MD.
Bioabsorbable Implants in Hand and Wrist Surgery
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