Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair: International Cartilage Repair Society Recommendations Based on Current Scientific Evidence and Standards of Clinical Care
| Autor: | Daniel B.F. Saris, Brian J. Cole, Mats Brittberg, Jian Yao, Jonas Ranstam, Kai Mithoefer, David W. Levine, Kenneth Zaslav, Matthew Shive, Elizaveta Kon, Jack Farr, Wilfried Dalemans |
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| Přispěvatelé: | Mithoefer, Kai, Saris, Daniel B.F., Farr, Jack, Kon, Elizaveta, Zaslav, Kenneth, Cole, Brian J., Ranstam, Jona, Yao, Jian, Shive, Matthew, Levine, David, Dalemans, Wilfried, Brittberg, Mats |
| Rok vydání: | 2015 |
| Předmět: |
clinical trial general
medicine.medical_specialty Regulatory issue ICRS Recommendation Papers Biomedical Engineering Physical Therapy Sports Therapy and Rehabilitation Scientific evidence medicine Articular cartilage repair Immunology and Allergy Medical physics Clinical care Cartilage repair cartilage repair repair regulatory issues business.industry Clinical study design knee joint involved Surgery Clinical trial Patient recruitment Clinical research general randomized controlled trials diagnostics Randomized controlled trials diagnostic business |
| Zdroj: | Cartilage |
| ISSN: | 1947-6035 |
| Popis: | Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. |
| Databáze: | OpenAIRE |
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