title: The relationship between the outcome of studies of autologous chondrocyte implantation and the presence of commercial funding.
abstract: 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.
  
  
  OBJECTIVE
  Commercially funded ACI literature could be commercially biased.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Taos Orthopaedic Institute, 1219-A Gusdorf Rd, Taos, NM 87571, USA. jlubowitz@kitcarson.net
authors.forename: James H
authors.initials: JH
authors.lastname: Lubowitz
authors.forename: David
authors.initials: D
authors.lastname: Appleby
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Centeno
authors.forename: Shane K
authors.initials: SK
authors.lastname: Woolf
authors.forename: John B
authors.initials: JB
authors.lastname: Reid
mesh_terms: D002358:Cartilage, Articular / Q000473:pathology / Q000601:surgery; D016009:Chi-Square Distribution; D019902:Chondrocytes / Q000637:transplantation*; D002986:Clinical Trials as Topic; D016265:Conflict of Interest; D019317:Evidence-Based Medicine; D006801:Humans; D017063:Outcome Assessment, Health Care; D017712:Peer Review, Research; D011643:Publishing; D012109:Research Support as Topic; D014182:Transplantation, Autologous