Bone graft substitutes in traumatology
Copyright policy )Bone graft substitutes in traumatology
Health political and scientific background Bone graft substitutes are increasingly being used as supplements to standard care or as alternative to bone grafts in the treatment of traumatic fractures. Research questions The efficacy and cost-effectiveness of bone graft substitutes for the treatment of traumatic fractures as well as the ethical, social and legal implications of their use are the main research questions addressed. Methods A systematic literature search was conducted in electronic medical databases (MEDLINE, EMBASE etc.) in December 2009. Randomised controlled trials (RCT), where applicable also containing relevant health economic evaluations and publications addressing the ethical, social and legal aspects of using bone graft substitutes for fracture treatment were included in the analysis. After assessment of study quality the information synthesis of the medical data was performed using metaanalysis, the synthesis of the health economic data was performed descriptively. Results 14 RCT were included in the medical analysis, and two in the heath economic evaluation. No relevant publications on the ethical, social and legal implications of the bone graft substitute use were found. In the RCT on fracture treatment with bone morphogenetic protein-2 (BMP-2) versus standard care without bone grafting (RCT with an elevated high risk of bias) there was a significant difference in favour of BMP-2 for several outcome measures. The RCT of calcium phosphate (CaP) cement and bone marrow-based composite materials versus autogenous bone grafts (RCT with a high risk of bias) revealed significant differences in favour of bone graft substitutes for some outcome measures. Regarding the other bone graft substitutes, almost all comparisons demonstrated no significant difference. The use of BMP-2 in addition to standard care without bone grafting led in the study to increased treatment costs considering all patients with traumatic open fractures. However, cost savings through the additional use of BMP-2 were calculated in a patient subgroup with high-grade open fractures (Gustilo-Anderson grade IIIB). Cost-effectiveness for BMP-2 versus standard care with autologous bone grafts as well as for other bone graft substitutes in fracture treatment has not been determined yet. Discussion Although there were some significant differences in favour of BMP-2, due to the overall poor quality of the studies the evidence can only be interpreted as suggestive for efficacy. In the case of CaP cements and bone marrow-based bone substitute materials, the evidence is only weakly suggestive for efficacy. From an overall economic perspective, the transferability of the results of the health economic evaluations to the current situation in Germany is limited. Conclusions The current evidence is insufficient to evaluate entirely the use of different bone graft substitutes for fracture treatment. From a medical point of view, BMP-2 is a viable alternative for treatment of open fractures of the tibia, especially in cases where bone grafting is not possible. Autologous bone grafting is preferable comparing to the use of OP-1. Possible advantages of CaP cements and composites containing bone marrow over autogenous bone grafting should be taken into account in clinical decision making. The use of hydroxyapatite material and allograft bone chips compared to autologous bone grafts cannot be recommended. From a health economic perspective, the use of BMP-2 in addition to standard care without bone grafting is recommended as cost-saving in patients with high-grade open fractures (Gustilo-Anderson grade IIIB). Based on the current evidence no further recommendations can be made regarding the use of bone graft substitutes for the treatment of fractures. To avoid legal implications, use of bone graft substitutes outside their approved indications should be avoided.
GMS Health Technology Assessment; 8:Doc04; ISSN 1861-8863
- Hannover Medical School Germany
ökonomisches Modell, KNOCHENERSATZMITTEL, medizinische Kosten, TECHNOLOGY ASSESSMENT, BIOMEDICAL, akademisches Review, Risikoabschätzung, validation studies as topic, models, economic, Meta-Analyse, bone substitutes/therapeutic use, PEER REVIEW, RISK ASSESSMENT, ECONOMICS, MEDICAL, Effizienz, humans, judgment, specifity, report, traumatology, Ökonomie, FRAKTUREN, KNOCHEN-, Übersichtsliteratur, HTA, review literature as topic, clinical trial, health policy, ärztliche Ökonomie, akademische Übersicht, technology, Kostensenkung, randomisierte kontrollierte Studien, SOZIALÖKONOMISCHE FAKTOREN, TRAUMATOLOGY, kontrollierte klinische Studien, medical evaluation, Peer Review, BONE SUBSTITUTES/THERAPEUTIC USE, CLINICAL TRIALS AS TOPIC, Metaanalyse, Article, SENSITIVITY AND SPECIFICITY, multizentrische Studien, Zufall, placebos, Technikfolgen-Abschätzung, biomedizinische, multicenter studies as topic, prospektive Studien, health technology assessment, HTA-report, Traumatologie, HTA report, Gesundheitsökonomie, Genauigkeitsstudie, MULTICENTER STUDIES AS TOPIC, bone substitutes/economics, randomized clinical trial, sensitivity, systematische Übersicht, MULTIZENTRISCHE STUDIEN, META-ANALYSIS AS TOPIC, TRAUMATOLOGIE, TECHNOLOGIE, multicenter study, MODELS, ECONOMIC, sensitivity and specificity, randomized controlled trial, REVIEW LITERATURE AS TOPIC, KONTROLLIERTE KLINISCHE STUDIEN, meta analysis, health funding, evidence based medicine, assessment, costs, PLACEBOS, fractures, bone, randomised clinical trial, health economics, health economic study, sozialökonomische Faktoren, COST CONTROL, cost effectiveness, HEALTH POLICY, COSTS AND COST ANALYSIS, Beurteilung, Verblindung, health, medical laboratory science, RANDOMISIERUNG, Sensitivität, randomised clinical study, RANDOM ALLOCATION, research article, TA, BONE AND BONES, controlled clinical trials as topic, Kosten-Nutzen-Analyse, technology evaluation, JUDGMENT, GESUNDHEITSPOLITIK, evidence-based medicine, Knochenfraktur, wirtschaftlicher Aspekt, CT, EFFICIENCY, EBM, TECHNIKFOLGEN-ABSCHÄTZUNG, BIOMEDIZINISCHE, Forschungsartikel, medizinische Evaluation, EVALUATION STUDIES AS TOPIC, KNOCHENTRANSPLANTATION, review, effectiveness, socioeconomic factors, bone and bones, sozioökonomischer Faktor, costs and cost analysis, decision making, evaluation study, socioeconomics, Entscheidungsfindung, Mensch, PLAZEBOS, Evaluationsstudien, VALIDIERUNGSSTUDIEN, BONE SUBSTITUTES/ECONOMICS, ÖKONOMIE, ÄRZTLICHE, cost control, ECONOMICS, controlled clinical trial, cost minimisation, cost-benefit analysis, MENSCH, Technologie, medizinische, Knochenbruch, blinded trial, KNOCHEN, economics, PROSPECTIVE STUDIES, PLACEBO EFFECT, meta-analysis, CONTROLLED CLINICAL TRIALS AS TOPIC, PROSPEKTIVE STUDIEN, fracture, evaluation studies as topic, placebo, research-article, random allocation, randomized study, BONE TRANSPLANTATION, accuracy study, bone graft, ÖKONOMIE, MEDICAL LABORATORY SCIENCE, Technologie, Kostendämpfung, medizinische Beurteilung, technology assessment, biomedical, Kostenminimierung, Kostenanalyse, Technology Assessment, cost analysis, Sozialökonomie, medizinische Wirksamkeit, cross-over studies, evaluation, Knochentransplantat, SOCIOECONOMIC FACTORS, Knochenersatzmittel, Health Technology Assessment, risk assessment, Knochentransplantation, technical report, medical economics, 610 Medical sciences; Medicine, meta-analysis as topic, bone fracture, Kosten, BONE SUBSTITUTES, cost-cutting, KLINISCHE STUDIEN, HEALTH, evidenzbasierte Medizin, cost reduction, COST-BENEFIT ANALYSIS, Bruch, Gesundheitsfinanzierung, PLAZEBOEFFEKT, Plazebo, randomization, verblindet, medical costs, HTA Bericht, cost minimization, blinding, klinische Studien, sickness costs, randomisation, DECISION MAKING, KOSTENDÄMPFUNG, blinded study, Technologiebewertung, Plazeboeffekt, accident, clinical study, technology assessment, economic aspect, ethics, randomised trial, prospective studies, CCT, Knochen, METAANALYSE, peer review, bone transplantation, randomised controlled trial, randomisierte klinische Studie, economic model, EVIDENCE-BASED MEDICINE, Kostenreduktion, Krankheitskosten, bone substitutes, randomized controlled trials as topic, Pharmaökonomie, ENTSCHEIDUNGSFINDUNG, Randomisierung, SENSITIVITÄT UND SPEZIFITÄT, Bericht, systematic review, pharmacoeconomics, medizinische Bewertung, EVALUATIONSSTUDIEN, HTA-Bericht, randomized trial, KOSTEN UND KOSTENANALYSE, EFFIZIENZ, controlled clinical study, Modelle, ökonomische, clinical trials as topic, RISIKOABSCHÄTZUNG, CROSS-OVER STUDIES, HUMANS, medizinische Technologie, Kosteneffektivität, Kosten-Effektivität, Knochenersatzmaterialien, medical efficacy, Technologiebeurteilung, technischer Bericht, BEURTEILUNG, ddc: 610, economics, medical, validation study, randomisierte Studie, Gesundheitspolitik, Wirksamkeit, RCT, RANDOMIZED CONTROLLED TRIALS AS TOPIC, Ethik, ÜBERSICHTSLITERATUR, gesundheitsökonomische Studie, Validierungsstudien, systematisches Review, KOSTEN-NUTZEN-ANALYSE, Fraktur, RANDOMISIERTE KONTROLLIERTE STUDIEN, ETHIK, Übersichtsarbeit, randomized clinical study, Spezifität, MODELLE, ÖKONOMISCHE, Technologieevaluation, TECHNOLOGY, VALIDATION STUDIES AS TOPIC, cost-effectiveness, GUTACHTENBASIERTE MEDIZIN, GESUNDHEIT, Placebo, medical assessment, Frakturen, Knochen-, FRACTURES, BONE, Gesundheit, random, socioeconomic factor, randomised study, review literature, blinded, ökonomischer Aspekt, efficiency, medical technology, sozialökonomischer Faktor, academic review, Bewertung, placebo effect, social economic factor, CROSS-OVER-STUDIEN, Kostenkontrolle, gutachtenbasierte Medizin, ETHICS, Effektivität
ökonomisches Modell, KNOCHENERSATZMITTEL, medizinische Kosten, TECHNOLOGY ASSESSMENT, BIOMEDICAL, akademisches Review, Risikoabschätzung, validation studies as topic, models, economic, Meta-Analyse, bone substitutes/therapeutic use, PEER REVIEW, RISK ASSESSMENT, ECONOMICS, MEDICAL, Effizienz, humans, judgment, specifity, report, traumatology, Ökonomie, FRAKTUREN, KNOCHEN-, Übersichtsliteratur, HTA, review literature as topic, clinical trial, health policy, ärztliche Ökonomie, akademische Übersicht, technology, Kostensenkung, randomisierte kontrollierte Studien, SOZIALÖKONOMISCHE FAKTOREN, TRAUMATOLOGY, kontrollierte klinische Studien, medical evaluation, Peer Review, BONE SUBSTITUTES/THERAPEUTIC USE, CLINICAL TRIALS AS TOPIC, Metaanalyse, Article, SENSITIVITY AND SPECIFICITY, multizentrische Studien, Zufall, placebos, Technikfolgen-Abschätzung, biomedizinische, multicenter studies as topic, prospektive Studien, health technology assessment, HTA-report, Traumatologie, HTA report, Gesundheitsökonomie, Genauigkeitsstudie, MULTICENTER STUDIES AS TOPIC, bone substitutes/economics, randomized clinical trial, sensitivity, systematische Übersicht, MULTIZENTRISCHE STUDIEN, META-ANALYSIS AS TOPIC, TRAUMATOLOGIE, TECHNOLOGIE, multicenter study, MODELS, ECONOMIC, sensitivity and specificity, randomized controlled trial, REVIEW LITERATURE AS TOPIC, KONTROLLIERTE KLINISCHE STUDIEN, meta analysis, health funding, evidence based medicine, assessment, costs, PLACEBOS, fractures, bone, randomised clinical trial, health economics, health economic study, sozialökonomische Faktoren, COST CONTROL, cost effectiveness, HEALTH POLICY, COSTS AND COST ANALYSIS, Beurteilung, Verblindung, health, medical laboratory science, RANDOMISIERUNG, Sensitivität, randomised clinical study, RANDOM ALLOCATION, research article, TA, BONE AND BONES, controlled clinical trials as topic, Kosten-Nutzen-Analyse, technology evaluation, JUDGMENT, GESUNDHEITSPOLITIK, evidence-based medicine, Knochenfraktur, wirtschaftlicher Aspekt, CT, EFFICIENCY, EBM, TECHNIKFOLGEN-ABSCHÄTZUNG, BIOMEDIZINISCHE, Forschungsartikel, medizinische Evaluation, EVALUATION STUDIES AS TOPIC, KNOCHENTRANSPLANTATION, review, effectiveness, socioeconomic factors, bone and bones, sozioökonomischer Faktor, costs and cost analysis, decision making, evaluation study, socioeconomics, Entscheidungsfindung, Mensch, PLAZEBOS, Evaluationsstudien, VALIDIERUNGSSTUDIEN, BONE SUBSTITUTES/ECONOMICS, ÖKONOMIE, ÄRZTLICHE, cost control, ECONOMICS, controlled clinical trial, cost minimisation, cost-benefit analysis, MENSCH, Technologie, medizinische, Knochenbruch, blinded trial, KNOCHEN, economics, PROSPECTIVE STUDIES, PLACEBO EFFECT, meta-analysis, CONTROLLED CLINICAL TRIALS AS TOPIC, PROSPEKTIVE STUDIEN, fracture, evaluation studies as topic, placebo, research-article, random allocation, randomized study, BONE TRANSPLANTATION, accuracy study, bone graft, ÖKONOMIE, MEDICAL LABORATORY SCIENCE, Technologie, Kostendämpfung, medizinische Beurteilung, technology assessment, biomedical, Kostenminimierung, Kostenanalyse, Technology Assessment, cost analysis, Sozialökonomie, medizinische Wirksamkeit, cross-over studies, evaluation, Knochentransplantat, SOCIOECONOMIC FACTORS, Knochenersatzmittel, Health Technology Assessment, risk assessment, Knochentransplantation, technical report, medical economics, 610 Medical sciences; Medicine, meta-analysis as topic, bone fracture, Kosten, BONE SUBSTITUTES, cost-cutting, KLINISCHE STUDIEN, HEALTH, evidenzbasierte Medizin, cost reduction, COST-BENEFIT ANALYSIS, Bruch, Gesundheitsfinanzierung, PLAZEBOEFFEKT, Plazebo, randomization, verblindet, medical costs, HTA Bericht, cost minimization, blinding, klinische Studien, sickness costs, randomisation, DECISION MAKING, KOSTENDÄMPFUNG, blinded study, Technologiebewertung, Plazeboeffekt, accident, clinical study, technology assessment, economic aspect, ethics, randomised trial, prospective studies, CCT, Knochen, METAANALYSE, peer review, bone transplantation, randomised controlled trial, randomisierte klinische Studie, economic model, EVIDENCE-BASED MEDICINE, Kostenreduktion, Krankheitskosten, bone substitutes, randomized controlled trials as topic, Pharmaökonomie, ENTSCHEIDUNGSFINDUNG, Randomisierung, SENSITIVITÄT UND SPEZIFITÄT, Bericht, systematic review, pharmacoeconomics, medizinische Bewertung, EVALUATIONSSTUDIEN, HTA-Bericht, randomized trial, KOSTEN UND KOSTENANALYSE, EFFIZIENZ, controlled clinical study, Modelle, ökonomische, clinical trials as topic, RISIKOABSCHÄTZUNG, CROSS-OVER STUDIES, HUMANS, medizinische Technologie, Kosteneffektivität, Kosten-Effektivität, Knochenersatzmaterialien, medical efficacy, Technologiebeurteilung, technischer Bericht, BEURTEILUNG, ddc: 610, economics, medical, validation study, randomisierte Studie, Gesundheitspolitik, Wirksamkeit, RCT, RANDOMIZED CONTROLLED TRIALS AS TOPIC, Ethik, ÜBERSICHTSLITERATUR, gesundheitsökonomische Studie, Validierungsstudien, systematisches Review, KOSTEN-NUTZEN-ANALYSE, Fraktur, RANDOMISIERTE KONTROLLIERTE STUDIEN, ETHIK, Übersichtsarbeit, randomized clinical study, Spezifität, MODELLE, ÖKONOMISCHE, Technologieevaluation, TECHNOLOGY, VALIDATION STUDIES AS TOPIC, cost-effectiveness, GUTACHTENBASIERTE MEDIZIN, GESUNDHEIT, Placebo, medical assessment, Frakturen, Knochen-, FRACTURES, BONE, Gesundheit, random, socioeconomic factor, randomised study, review literature, blinded, ökonomischer Aspekt, efficiency, medical technology, sozialökonomischer Faktor, academic review, Bewertung, placebo effect, social economic factor, CROSS-OVER-STUDIEN, Kostenkontrolle, gutachtenbasierte Medizin, ETHICS, Effektivität
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