Do anterior cruciate ligament allograft culture results correlate with clinical infections?

PURPOSE: In 1998, four cases of contaminated allografts for anterior cruciate ligament (ACL) reconstruction resulted in Clostridium infection, and a patient with Clostridium infection from a femoral condylar allograft died. It was subsequently published that implanting surgeons should culture ACL allografts so that action could be taken should highly pathogenic bacteria be encountered. The purpose of this study is to test the hypothesis that ACL allograft cultures correlate with clinical infections. METHODS: Since October 2003, a single surgeon performing ACL reconstruction prospectively cultured all allografts in the operating room before implantation. After culture, grafts were thawed in warm saline mixed with bacitracin. All patients received a single dose of preoperative antibiotics. Final culture results were obtained in all patients, and all patients were followed for a minimum of 90 days to evaluate for postoperative infection. The cost of cultures was determined by multiplying hospital charges by the hospital cost-to-charges ratio. RESULTS: Two hundred and ten cases were included. Ten allografts (4.8%) had positive culture results (6 coagulase-negative Staphylococci, 1 alpha-Streptococcus-not-group-B, 1 Enterobacter, 1 Clostridium, and 1 polymicrobial [Klebsiella, Escherichia coli, and Enterococcus]). None of these patients had signs of infection; the three positive highly pathogenic bacteria (Enterobacter, Clostridium, and polymicrobial) graft recipients were treated with antibiotics. The others were observed. One patient with negative cultures developed Staphylococcus aureus infection. Mean culture cost was $127 (USD). CONCLUSIONS: Our results demonstrate that ACL allograft cultures do not correlate with clinical infections. LEVEL OF EVIDENCE: Level I, diagnostic study (testing of previously developed diagnostic criteria [culture]) in a series of consecutive patients (with universally applied reference gold standard [clinical evaluation for knee sepsis]).

The relationship between the outcome of studies of autologous chondrocyte implantation and the presence of commercial funding.

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.