The relationship between the outcome of studies of autologous chondrocyte implantation and the presence of commercial funding
ABSTRACT 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.
Commercially funded ACI literature could be commercially biased.
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.
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.
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.
- SourceAvailable from: InTechModern Arthroscopy, 12/2011; , ISBN: 978-953-307-771-0
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ABSTRACT: For articular cartilage defect treatment, many treatment modalities have been developed. We evaluate the cartilage repair potential of an atelocollagen and fibrin mixture transplanted to cartilage defects. A circular, articular cartilage defect 4 mm in diameter was made in the trochlear region in each of 20 New Zealand white rabbits. The 10 rabbits in the control group were kept without treatment and the 10 rabbits in the experimental group underwent injection of atelocollagen mixed with fibrin. At week 12 following surgery the cartilage was observed and histologically compared in both groups. The surface of the newly generated cartilage was very smooth and even, and we also noted that the entire area was completely regenerated in the experimental group. The control group showed incomplete and irregular cartilage formation in the defect. Regarding the histological scoring, comparison of the two groups differed significantly (p < 0.001). Injection of a mixture of atelocollagen and fibrin used to treat articular cartilage defects of the knee appears to be an effective method for cartilage regeneration. © 2013 S. Karger AG, Basel.Cells Tissues Organs 12/2013; 198(4). DOI:10.1159/000356488 · 2.14 Impact Factor
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ABSTRACT: The purpose of the present study was to determine (1) whether the current literature supports the choice of using autologous chondrocyte implantation over other cartilage procedures with regard to clinical outcome, magnetic resonance imaging, arthroscopic assessment, and durability of treatment, (2) whether the current literature supports the use of a specific generation of autologous chondrocyte implantation, and (3) whether there are patient-specific and defect-specific factors that influence outcomes after autologous chondrocyte implantation in comparison with other cartilage repair or restoration procedures. We conducted a systematic review of multiple databases in which we evaluated Level-I and II studies comparing autologous chondrocyte implantation with another cartilage repair or restoration technique as well as comparative intergenerational studies of autologous chondrocyte implantation. The methodological quality of studies was evaluated with use of Delphi list and modified Coleman methodology scores. Effect size analysis was performed for all outcome measures. Thirteen studies (917 subjects) were included. Study methodological quality improved with later publication dates. The mean modified Coleman methodology score was 54 (of 100). Patients underwent autologous chondrocyte implantation (n = 604), microfracture (n = 271), or osteochondral autograft (n = 42). All surgical techniques demonstrated improvement in comparison with the preoperative status. Three of seven studies showed better clinical outcomes after autologous chondrocyte implantation in comparison with microfracture after one to three years of follow-up, whereas one study showed better outcomes two years after microfracture and three other studies showed no difference in these treatments after one to five years. Clinical outcomes after microfracture deteriorated after eighteen to twenty-four months (in three of seven studies). Autologous chondrocyte implantation and osteochondral autograft demonstrated equivalent short-term clinical outcomes, although there was more rapid improvement after osteochondral autograft (two studies). Although outcomes were equivalent between first and second-generation autologous chondrocyte implantation and between open and arthroscopic autologous chondrocyte implantation, complication rates were higher with open, periosteal-cover, first-generation autologous chondrocyte implantation (four studies). Younger patients with a shorter preoperative duration of symptoms and fewer prior surgical procedures had the best outcomes after both autologous chondrocyte implantation and microfracture. A defect size of >4 cm(2) was the only factor predictive of better outcomes when autologous chondrocyte implantation was compared with a non-autologous chondrocyte implantation surgical technique. Cartilage repair or restoration in the knee provides short-term success with microfracture, autologous chondrocyte implantation, or osteochondral autograft. There are patient-specific and defect-specific factors that influence clinical outcomes.The Journal of Bone and Joint Surgery 09/2010; 92(12):2220-33. DOI:10.2106/JBJS.J.00049 · 4.31 Impact Factor