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This Article Full Text Full Text (PDF) An erratum has been published All Versions of this Article: 35/11/1809    most recent 0363546507304720v1 Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints and Permissions Request Reprints Citing Articles Citing Articles via ISI Web of Science (1) Citing Articles via Google Scholar Google Scholar Articles by Lubowitz, J. H. Articles by Reid, J. B. Search for Related Content PubMed PubMed Citation Articles by Lubowitz, J. H. Articles by Reid, J. B., III Related Collections Chondral/cartilage Knee

The Relationship Between the Outcome of Studies of Autologous Chondrocyte Implantation and the Presence of Commercial Funding

James H. Lubowitz, MD^,*, David Appleby, MPH, Joseph M. Centeno, MD, Shane K. Woolf, MD and John B. Reid, III, MD

From the Taos Orthopaedic Institute Research Foundation, Taos, New Mexico, and Smith & Nephew, Andover Massachusetts

^* Address correspondence to James H. Lubowitz, MD, Taos Orthopaedic Institute, 1219-A Gusdorf Rd, Taos, NM 87571 (e-mail: jlubowitz{at}kitcarson.net).

Background: Autologous chondrocyte implantation (ACI) is an expensive treatment option for focal cartilage defects, and commercial funding of research is associated with a study reaching a positive conclusion. The purpose of this analysis is to compare outcomes (and levels of evidence) between published ACI outcome studies that were commercially funded and studies that were not commercially funded.

Hypothesis: Commercially funded ACI literature could be commercially biased.

Study Design: Comparative meta-analysis.

Methods: MEDLINE was searched for human, knee, ACI, nonmembrane, English language, and clinical outcome studies. Studies were evaluated with regard to funding status (commercially funded or not commercially funded), outcomes, and levels of evidence. Outcomes and levels of evidence were evaluated and compared for commercially funded studies versus those that were not commercially funded.

Results: Twenty-three studies were included; 16 (70%) were commercially funded. Pooled clinical outcome measures data were not significantly different (Lysholm, Modified Cincinnati, patient-reported Cincinnati, Tegner, pain Visual Analog Scale) when comparing commercially funded studies with those that were not commercially funded. However, distribution of levels of evidence was significantly lower (P = .045) for commercially funded studies.

Conclusion: Reassuringly, commercial funding of ACI studies did not result in a difference in published clinical outcomes versus those that were not commercially funded. However, the lower levels of evidence of commercially funded studies suggests that commercially funded ACI studies may be of less value to surgeons desiring to practice evidence-based medicine, and, in the future, commercial entities funding medical research could selectively fund studies of the highest levels of evidence.

Key Words: autologous chondrocyte implantation • autologous chondrocyte transplantation • meta-analysis • bias • funding • commercial