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

Kai Mithoefer, Daniel B F Saris, Jack Farr, Elizaveta Kon, Kenneth Zaslav, Brian J. Cole, Jonas Ranstam, Jian Yao, Matthew Shive, David Levine, Wilfried Dalemans, Mats Brittberg

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)100-121
Number of pages22
JournalCartilage
Volume2
Issue number2
DOIs
Publication statusPublished - Apr 2011

Keywords

  • Cartilage repair repair
  • Clinical trial general
  • General
  • Knee joint involved
  • Randomized controlled trials diagnostics
  • Regulatory issues

ASJC Scopus subject areas

  • Immunology and Allergy
  • Biomedical Engineering
  • Physical Therapy, Sports Therapy and Rehabilitation

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