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Bone Grafts andBone Graft Substitutes
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RobertMorrison
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12.1 Introduction and Core Messages
Bone grafts or substitutes are used in spinal surgery to ll defects, to bridge defects or to promote spondy­lodesis. The physiological process is similar to that of fracture healing and incorporates the same spatial and temporal factors. The ideal material should provide osteogenetic, osteoinductive and osteoconductive properties. The traditional autologous bone grafts are probably still considered the “golden standard”, but the problems associated with them bring up the need for substitutes. One alternative is the acquirance of allogenic or xenogenic bone grafts, which have spe­cic problems of their own, which limit their use. The other aspect is the use of bone substitutes, which come in a growing variety of materials, shapes and applica­tion forms. Currently, none of these substitutes unite all of the prerequisites shown above, but they have the advantage of unlimited supply without causing addi­tional problems such as donor site morbidity. And the combination of such substitutes as scaffold with the utilization of growth factors and mesenchymal stem cells brings with them a completely new array of possibilities.
12.2 Denition
12.2.1 Bone Graft
The bone is harvested from different parts of the patient. It is most commonly from the iliac crest but also from the verte­bral structures, the ribs, the tibia as well as the bula [1].
R. Morrison (*) Spine & Scoliosis Center, Asklepios Klinik Bad Abbach, Germany e-mail: dr.morrison@web.de
12.2.2 Bone Graft Substitute
It replaces the autologous bone in order to achieve defect lling and bridging and also fusion [2]. It provides unlimited supply and eliminates donor site morbidity. But no substitute provides the combination of osteoinductive, osteoconductive and osteogenetic properties [1].
12.3 Physiology ofBone Regeneration
The bone is one of the few organs that retains the potential for regeneration throughout life. In contrast to other organs, the bone does not repair defects with scar material of poor quality but rather reinstates its original values. But fracture healing and therefore also bone regeneration are complex physiological processes.
Two basic principles of bone healing are described in lit-
erature [3] as follows:
• Primary bone healing (“direct healing”) is very rare and not the usual form of healing achieved in spinal surgery.
• Secondary bone healing involves intramembranous and endochondral ossication and leads to callus formation. Callus formation is achieved through undifferentiated multipotent mesenchymal stem cells (MSCs) and requires cell vitality and blood supply. In this cascade of bone regeneration, certain prerequisites
are known. Most importantly, a vital cell population has to be present. MSCs have to be either present or transferred to the site via blood supply. These cells are transferred to a cell population with osteoblastic phenotypes.
In addition, the fracture haematoma offers a vast supply of
signalling molecules (ILs, TNFs, TGFs, VEGF) to induce healing. Within the group of TGFs, the so-called bone mor­phogenetic proteins (BMP-2, BMP-7) have been extensively studied and shown to play a decisive role in the healing process [4]. The third important element is the extracellular matrix, providing a natural scaffold for the cellular interactions. This
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Osteogenic
cells
Diamond
concept
Mechanical
vironment
Fig. 12.1 “Diamond concept” regarding bone healing [5]
Osteoconductiv
scaffolds
Growth
factors
R. Morrison
supply of the cancellous as well as cortical bone (tricortical graft) (Figs.12.2 and 12.3).
Advantages
• Osteogenetic
• Osteoconductive
• Osteoinductive
Disadvantages
• Limited supply.
• High failure rate is reported.
• Risk of iliac crest fracture (Fig.12.4).
• Correctional loss due to remodelling [6].
• Donor site morbidity (limited with correct utilization).
• Additional operation time.
Harvest sites
• Iliac crest (anterior, posterior)
• Locally (vertebral body, spinous process, lamina, etc.)
• Rib portion (in transthoracic approaches)
• Tibia/bula
can be replaced by an immense number of osteoconductive materials such as allografts, demineralized bone matrix (DBM), hydroxyapatite and calcium-based ceramics, among others. These scaffolds have been shown to have an optimal pore size of 150–500μm. The last important factor, important for fracture healing and bone formation, is the mechanical sta­bility. All four components combined are described as the “diamond concept” (Fig.12.1). It is well described in extrem­ity fractures and of equal importance in spinal surgery [5].
12.4 Clinical Application
Therefore, bone or bone substitutes should preferably have the three properties mentioned above. Osteogenicity refers to the fact that they contain osteoblastic cells and are thereby capable of directly forming the bone. Osteoconductivity refers to the situation in which they provide a structure along which osteoblasts can attach and thereby the bone can grow. Osteoinductivity is the ability to induce nondifferentiated stem cells or osteoprogenitor cells to differentiate into osteo­blasts. A “perfect” bone graft substitute would incorporate all three characteristics.
12.5 Autologous Bone Grafts
The “golden standard” of bone grafts is the autologous bone, although it is an area of growing controversy [1]. It is mostly harvested from the iliac crest, depending upon positioning of the patient. This donor site has the advantage of having a
12.6 Surgical Technique ofIliac Crest Graft
Harvesting
The bone from the iliac crest can be easily harvested. When choosing the anterior crest, one must be aware of the lateral femoral cutaneous nerve. On the other hand, a safety margin of at least 3 cm should be left from the anterior superior crest, where the hip exion muscles derive from. We recom­mend harvesting the graft using a double-blade oscillating saw. The desired depth can also be harvested using a “graft cutter”. This way a dened cortical graft is obtained, leaving room for additional harvesting of cancellous bone chips using a spoon. The defect is lled using a haemostatic pad, the fascia is closed and a drain should be placed to prevent a painful haematoma. Alternatively, according to the clinical application, “bone plugs” can also be harvested using special instruments (Fig.12.5). This leaves less defect and can also be harvested in other locations.
12.7 Bone Graft Substitutes
These materials should ideally have the osteogenetic, osteo­conductive and osteoinductive characteristics of an auto­graft without the substantial side effects. Most of these materials only provide osteoconductivity. Their integration into the bone substance can take place in different ways [7]. One way is the direct integration or resorption followed by conversion into the bone. The other way would be some kind of “graft- versus- host reaction” resulting in a self-con­tained graft or even a (partial) loss of graft substance with­out integration [8].
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Fig. 12.2 CT scans in three planes documenting the correct size and positioning of a tricortical autograft
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Fig. 12.3 Plain radiograph of a monosegmental, anterior spondylode-
sis with a tricortical iliac crest autograft following bisegmental, poste­rior stabilization
12.8 Allografts
This relates to the tissue taken from one person for transplan­tation into another. This type of treatment has spread due to recent improvements in procurement, preparation and stor­age. Clinics with a high turnover of allografts have their own storage areas. This concept of bone banking is connected to a great deal of legal issues, showing great variations in differ­ent countries [9]. They are useful however to enlarge the vol­ume of the autologous bone.
Fig. 12.4 Iliac crest fracture following bone harvest from the anterior
iliac crest in the right side
Advantages
• Osteoconductive
• Unlimited supply
• Multiple shapes and sizes
• No donor site morbidity
Disadvantages
• Not osteogenic (due to chemical processes in the making)
• Weak osteoinductive properties
• Possibility of infectious disease transmission
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Fig. 12.5 Bone graft harvesting set (Synthes) used for different sizes of “plugs” (© by Synthes)
12.9 Demineralized Bone Matrix (DBM) andBone Morphogenetic Protein (BMP)
DBM is a demineralized allograft bone with osteoinductive activity [10]. Demineralized bone matrixes are prepared by acid extraction of the allograft bone, resulting in loss of most of the mineralized components but retention of collagen and noncollagenous proteins, including growth factors. The ef­cacy of a demineralized bone matrix (DBM) as a bone graft substitute or extender may be related to the total amount of bone morphogenetic protein (BMP) present and the ratios of the different BMPs present. The multitude of different BMPs are all capable of recruiting bone-forming cells and encourag­ing local cells to aid in the bone formation process. There are up to now over 20 different BMPs known, but the clinical research is currently limited to BMP-2 and BMP-7. The differ­ent types of BMPs seem to show substantial variations in their osteogenetic potency. Recently, BMP has been associated with cancer, but further studies have found no correlation [11].
Advantages
• Osteoinductive with promoted bone formation [12].
• Osteoinductive potency is very variable in different prod-
ucts [4].
• Graft extender (in combination with autografts).
Disadvantages
• Poor structural integrity
• BMP alone not osteoconductive
12.10 Hydroxyapatite (Ca10(PO4)6(OH)2) andTricalcium Phosphate (Ca3(PO4)2)
These substitutes are mainly known as bone void llers. Taking into account their specic strengths (e.g. fast curing, uid injection, etc.) and their weaknesses (low shear stress, poor biodegradability, etc.), new applications have arisen. These materials come in a wide array of different application forms (Fig.12.6).
Advantages
• Osteoconductive (Fig.12.7)
• Lasting stability
• Availability
Disadvantages
• Not osteoinductive
• Not osteogenic
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Fig. 12.6 An array of different forms and shapes used in calcium phos-
phate bone substitutes (© by Synthes)
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a
b
Table 12.1 Exemplary list of calcium phosphate products on the mar-
ket (among others)
Product Company Type Nanostim Medtronic Synthetic tricalcium BoneSource Howmedica CaP cement Alpha-BSM DePuy CaP cement Calcibon Biomet/Merck CaP putty MIMIX Biomet Synthetic tricalcium phosphate Cerasorb Curasan Beta-tricalcium phosphate ChronOS Synthes Beta-tricalcium phosphate Vitoss Orthovita Beta-tricalcium phosphate Pro osteon Interpore cross Coralline hydroxyapatite Endobon Biomet/Merck Cancellous hydroxyapatite BioFuse Corin Hydroxyapatite/CaP Actifuse ApaTech Silicated calcium phosphate
12.11 Clinical Application
Current evolutions within this eld, such as biphasic, inject­able CaP and silicated CaP, widen the array of applications, offering a good supplement in achieving spinal fusion [13] (lling cages, lining cages, extending grafts, etc.) (Table12.1). These substances should be rehydrated using the patients’ blood before applying (Fig.12.8).
Fig. 12.7 (a, b) Histological ndings using chronOS mixed with blood
6weeks (a) and 12weeks postoperatively (© by Synthes)
Fig. 12.8 ChronOS blocs mixed with blood (© by Synthes)
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12.12 Other Ceramics (Sea Corals, Calcium Sulphate)
These substances are currently researched to evaluate their usefulness to supplement or even replace the ceramics in use today.
12.13 Outlook
Tissue engineering and the further development of growth factors offer great potential for the future of fusion and bone substitutes. Materials will evolve and offer “ideal” and indi­vidual solutions for specic indications [14]. But currently, the autologous bone is still the golden standard [15]. The diversity of current substitutes will make further comparative studies quite difcult.
References
1. Sen MK, Miclau T.Autologous iliac crest bone graft: should it still
be the gold standard for treating nonunions? Injury. 2007;38(Suppl
1):S75–80.
2. Bone Graft Alternatives (according to the North American Spine
Society). http://www.spine.org/Documents/bone_grafts_2006.pdf
3. Phillips AM. Overview of the fracture healing cascade. Injury.
2005;36(Suppl 3):S5–7.
4. Papakostidis C, Kontakis D, Bhandari M, etal. Efcacy of autolo-
geous iliac crest bone graft and bone morphologic proteins for pos-
terolateral fusion of lumbar spine– a metaanalysis of the results. Spine. 2008;33(19):E680–92.
5. Giannoudis PV, Einhorn TA, Marsh D.Fracture healing: the dia­mond concept. Injury. 2007;38(Suppl 4):S3–6.
6. Morrison RH, Thierolf A, Weckbach A. Volumetric changes of iliac crest autografts used to reconstruct the anterior column in thoracolumbar fractures: a follow-up using CT scans. Spine. 2007;32(26):3030–5.
7. Berven S, Tay BK, Kleinstueck FS, etal. Clinical applications of bone graft substitutes in spine surgery: consideration of mineralized and demineralized preparations and growth factor supplementation. Eur Spine J. 2001;10(Suppl 2):S169–77.
8. Schimandle JH, Boden SD. Bone substitutes for lumbar fusion: present and future. Oper Tech Orthop. 1997;7:60–7.
9. Friedlaender GE. Bone-banking. J Bone Joint Surg Am. 1982;64:307–11.
10. Petersen B, Whang PG, Iglesias R, et al. Osteoinductivity of commercially available demineralized bone matrix. Preparations in a spine fusion model. J Bone Joint Surg Am. 2004;86-A(10): 2243–50.
11. Cooper GS, Kou TD. Risk of cancer following lumbar fusion surgery with recombinant human bone morphogenic protein-2 (rhBMP-2): an analysis using a commercially insured patient popu­lation. Int J Spine Surg. 2018;12(2):260–8.
12. Kwong FN, Harris MB.Recent developments in the biology of fracture repair. J Am Acad Orthop Surg. 2008;16(11):619–25.
13. Becker S, Maissen O, Ponomarev I, etal. Osteopromotion by a beta-tricalcium phosphate/bone marrow hybrid implant for use in spine surgery. Spine. 2006;31(1):11–7.
14. Giannoudis PV, Tzioupis CC, Tsirids E.Gene therapy in orthopae­dics. Injury. 2006;37(Suppl 1):S30–40.
15. Morris MT, Tarpada SP, Cho W. Bone graft materials for pos­terolateral fusion made simple: a systematic review. Eur Spine J. 2018;27:1856–67.
On- andOffline Documentation
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ofSpine Procedures: Spine Tango
ThomasZweig, MarcoTeli, EverardMunting, SamuelMorris, andMarkusMelloh
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13.1 Introduction and Core Messages
Today, quality assurance and systematic data collections are nally becoming more commonplace; however, they are often independent undertakings of surgeons or hos­pitals. As a result, the isolated use of databases and con­tent to study smaller groups makes data pooling and harmonisation difcult and impedes important quality assurance processes, particularly benchmarking. In 2000, EuroSpine, the Spine Society of Europe, at the initiative of Dieter Grob and Max Aebi and with the help of Chris Röder, launched Spine Tango, an on- and ofine registry of spinal interventions (surgical and con­servative) aimed at assuring quality in outcome research and enabling national and international benchmarking. A scientic clinical fellowship was introduced to sup­port the distribution on every layer. Spine Tango later evolved to include postmarket surveillance of surgical implants. Information on Spine Tango and a battery of recommended physician and patient-based instruments can be found under www.eurospine.org—Spine Tango.
T. Zweig (*) Spine in the Center, Bern/Langenthal, Switzerland e-mail: spine@hin.ch
M. Teli The Walton Centre for Neurology and Neurosurgery, Liverpool, UK
E. Munting Clinique Saint Pierre, Ottignies, Belgium
S. Morris Centre for Spinal Studies and Surgery, Queen’s Medical Centre, Stockport, UK
M. Melloh Institute of Health Sciences, Zurich University of Applied Sciences, Winterthur, Switzerland
UWA Medical School, The University of Western Australia, Nedlands, Western Australia, Australia
13.2 Denition ofQuality inHealth Care
To those not involved in quality improvement in a profes­sional capacity, it might appear a relatively simple task to dene “quality”; however, more than 2000years after Plato invented this term, there is still great debate regarding the meaning of the word [1]. The American Society for Quality (ASQ) denes quality as “a subjective term for which each person has his or her own denition” [2]. According to a user-based approach, quality can be dened as “meeting or exceeding customer satisfaction” [3]. Quality is a multidi­mensional construct, and the dimensions are specic to each category. The US Agency for Healthcare Research and Quality denes quality in health care as “doing the right thing, at the right time, in the right way, for the right person, and having the best possible results” [4].
The quality measures in health care assess the following
three components:
• Structure (resources such as staff and equipment)
• Process (therapeutic interventions, prescribing, interac-
tions with patients)
• Outcomes (end results of health care such as mortality
and attainment of patient’s expectations) [4, 5]
Wensing and Elwyn [6] dened preferences as patient’s ideas about what should occur in health-care systems. Evaluations are patient’s “reactions” to their experience of health care, and reports are objective observations (e.g. how long the patients had to spend in the waiting room).
The measures used to obtain the patients’ view can be classied into the following three categories:
• Preferences
• Evaluations
• Reports
Naturally, the scope and utility of a quality measurement process will depend on the choices made when selecting mea­surement tools. The choice of the type of measure depends on the aspect being assessed and the purpose of the evaluation (educational, certication, accreditation, quality control or quality improvement) [7]. One of the most widespread means
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of measuring processes and outcomes is the assessment of patient satisfaction (evaluation category). Outcome satisfac­tion is also one of the criteria for assessing the validity of pro­cess measures. Indeed, according to Chassin [8], a measure of process is valid when it is related to health outcomes (mortal­ity, patient satisfaction, etc.). Hence, the responses to ques­tions concerning satisfaction with treatment, typically used in treatment outcome studies, can also be seen as outcome mea­sures in the quality control and improvement context.
13.2.1 Overlap ofOutcome Research andQuality Control
Medical disciplines have adopted the practice of quality control through data collection and measurement tools, but there is often less enthusiasm among medical institutions to be guided by data and implement ndings in a rigorous or systematic fashion. The growing emphasis on an evidence- based approach in the medical setting has led to a corresponding increase in the number and quality of studies in the twenty-rst century, exam­ining the efcacy of surgical and non-surgical treatments. These studies are usually conducted in university hospitals and clinics that have an in- house research staff or that cooperate with academic research institutions. The studies are not com­monly perceived by the care provider (hospitals and clinics) as being something from which they can benet from an econom­ical point of view; in contrast, carrying out such research can sometimes be seen as a drain of resources. The research activi­ties on treatment outcomes are merely seen as something that may indirectly benet the institution in terms of prestige and corporate social responsibility. However, the possibility of eco­nomic benet from corporate social responsibility activities is not a sufciently persuasive argument for increasing invest­ment in research—otherwise, all the public and private hospi­tals and clinics would likely have their own research departments or research staff. Signicantly, in all of this, one important factor is typically overlooked: research projects in the eld of treatment outcomes and their predictors can be use­ful to the provider in a much more direct way in terms of qual­ity improvement and the control of service performance [9].
variety of levels, pathologies, accesses and surgical tech­niques confounds all attempts to formulate a concise yet comprehensive questionnaire. Under the auspices of EuroSpine, the Spine Society of Europe, a project was launched for the design and implementation of a documenta­tion system for spinal surgery in 2000. This effort was intro­duced as “Spine Tango” and was conducted in collaboration with the Institute for Evaluative Research in Orthopaedic Surgery at the University of Bern, Switzerland.
Goals of Spine Tango were the following:
• Presentation of state-of-the-art European spine surgery, including all pathologies, levels, accesses and single- as well as multiple-staged surgeries
Outcome research and prospective observational evalua- tion of different surgical techniques as an alternative to randomised controlled trials
Benchmarking on national and international levels
Quality assurance and quality improvement Spine Tango was probably the rst international spine
registry initiative to face the challenge of developing a com­prehensive questionnaire covering all major spine patholo­gies and interventions, as well as spanning all anatomical levels. To accomplish this task, a technically demanding computer application was a prerequisite. The consensus and piloting process for the Spine Tango surgical questionnaires “surgery” and “follow-up” took about 5years and required around 4000 completed forms. The results are two double­sided A4 questionnaires (surgery, staged surgery) and one single-sided questionnaire for follow-up, all of which can be completed online or using scannable paper questionnaires. At the same time that the physician-based content was nal­ised, a working group at the Schulthess Hospital in Zurich, Switzerland, had developed and validated the COMI (Core Outcome Measures Index) instruments for neck and low back pain which became the ofcially recommended patient­based documentation instruments in the framework of the Spine Tango registry [10]. To date, the Spine Tango database has grown to over 750,000 cases, and currently, about 40 hospitals participate from 5 continents and will become the mandatory register in Switzerland and Germany while in the pilot phase in Belgium [11].
13.3 EuroSpine “Spine Tango”: An International Spine Registry forQuality Assurance, Outcome Research, Postmarket Surveillance ofImplants andConservative Interventions
13.3.1 History andObjectives
All over the world, efforts are being made to set up surgical registries on regional, state or even national levels. Spine sur­gery represents a challenge for all registry endeavours. The
13.3.2 Content: Physician Based
The rened set of questions still allows documentation of the broad spectrum of pathologies and treatments in spine surgery. This is made possible by means of a list of main pathologies and their specications and the so-called surgical matrix, a ter­minology system reducing the interventions to their basic principles—decompression, fusion, stabilisation rigid, stabili­sation motion preserving, percutaneous procedures and oth­ers. The duplication and, hence, separation of these principles into anterior and posterior ones completes the matrix.
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Fig. 13.1 SSE Spine Tango surgery form (front and back side). All questions with blue background are mandatory
13.3.3 Surgery Form
the matrix questions need to be completed. Typically, this can
be done with two to four questions. Finally, the “discharge” The rst half of the front page of the “surgery” form serves to specify the level of the procedure, admission date, case his­tory (previous conservative and surgical treatments), main and additional pathology, most severely affected segment and
subform inquires about the discharge date, surgical and gen-
eral in-hospital complications, measures taken and status of
complications upon discharge. It makes up between three and
seven questions (Fig.13.1). extent of lesion. This information is grouped into the “admis­sion” subform. The “specication of main pathology” sub­form makes up the second part of page one and comprises one
13.3.4 Staged Surgery Form
to three questions per “main pathology” category. These serve to provide more information about the main pathology. On the reverse side of the sheet are the “surgery”, “surgical mea­sures” and “discharge” subforms. The “surgery” subform is the largest (12 questions) and inquires about surgery date, implants used, goals of surgery, the surgical matrix, surgeon credentials, access and technology, operation time, morbidity state and blood loss. The “surgical measures” subform applies the same principle as the “specication of main pathology” subform—only the items relevant to the information given for
In addition to the surgery form, there is also a so-called
staged form and a follow-up form. The staged form serves to
document the second part of a planned two-stage procedures,
that is, procedures where the patient remains in the hospital
between the rst and the second interventions. If the patient
is discharged, a new surgery form must be completed. Also,
if an early revision is carried out, the correct way to docu-
ment this is with a new surgery form with the diagnosis
“failed surgery”.
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Fig. 13.2 SSE Spine Tango follow-up form (one page only)
13.3.5 Follow-Up Form
The follow-up form is just one side of the A4 sheet and con­sists of a “follow-up” subform and a “complications” sub­form. In its paper format, it can be completed in less than 1min. After the date of follow-up and the follow-up interval have been completed, the patient’s work status is docu­mented, and the surgical goals that were achieved, partially achieved or not achieved at all are indicated. Only the surgi­cal goals that are indicated on the surgery form are to be considered. Current medication, rehabilitation and the sur­geon’s rating of the outcome are then recorded. The last question in the “follow-up” subform inquires about the need (or not) for further follow-up, revision surgery or another pri­mary intervention.
In the absence of complications, the “complications” subform can be completed with just one answer “no” to the “complications” question. Where complications have arisen, the point of time at which they occurred, the type of complications and the therapeutic and individual conse­quences are inquired about (Fig. 13.2). All forms can be found as PDF les under www.eurospine.org—Spine Tango—forms.
T. Zweig et al.
13.3.6 Content: Patient Based
The proportion of positive outcomes after spinal surgery depends to a large extent on the manner in which outcome is assessed [12], and there is no single, universally accepted method. In the past, clinicians typically judged the outcome from their own perspective, using simple rating schemes such as “excellent, good, moderate and poor”. The technical success of the operation also lent itself to evaluation by means of sophisti­cated imaging at follow-up. However, most of the time, these measures proved to be only weakly associated with outcomes of relevance to the patient and to society [13]. It is now widely accepted that the focus should be placed on patient-orientated measures and that the patient should be the main judge of out­come, with the result that clinician-based methods have been complemented by a diverse range of patient self-assessment questionnaires. A standardised set of outcome measures for use with back patients were proposed in 1998 by a multinational group of experts [13]. There was general consensus that the most appropriate core outcome measures should include the fol­lowing domains: pain, back-specic function, generic health status (well-being), work disability, social disability and patient satisfaction [13, 14]. Accordingly, the group proposed a parsi­monious set of seven preoperative questions that would cover each of these domains, yet be brief enough to alleviate the respondent’s burden, and hence be practical for routine clinical use and quality management. At the time of follow-up, informa­tion about occurrence of complications and their bothersome­ness from the patient’s perspective, reoperations, satisfaction with overall medical care in the hospital and extent to which surgery helped are inquired with four additional questions. The satisfaction question may, for example, be used to evaluate the patient’s perception of the “process performance” in a six-sigma quality improvement initiative [8, 9]. Sufcient clinical research has meanwhile been conducted with the COMI score outcome forms for providing details about their application and adminis­tration and about clinically and statistically important facts like the minimum clinically relevant score improvement, stan­dardised response mean values (effect sizes) and dichotomisa­tion of outcomes into “good” and “poor” results [15] (Fig.13.3). All COMI forms can be found as PDF les under www.
eurospine.org—Spine Tango—forms.
13.3.7 Content: Conservative Form
It took more than a decade from the launch of Spine Tango in 2000 before the need for a documentation form for non­surgical treatments of the spine led to the development of a “Spine Tango Conservative” form (Kessler etal. Eur Spine J
2011). Shortly afterwards followed patient-based forms for the non-surgical treatment of the back and neck (COMI back conservative/COMI neck conservative). Implementation of the Spine Tango Conservative 2011 form has been reported in a UK, secondary care setting [11, 16]. In 2018, an interna-