The value of serial metal ion levels in following up patients with metal-on-metal hip arthroplasty.

BACKGROUND: The sensitivity of cobalt (Co) and chromium (Cr) ion-levels in detecting poorly performing metal-on-metal hip implants is low. This study proposes that serial changes in ion-levels are a more accurate marker of arthroplasties at risk. METHODS: Serial metal ion-levels and implant data of 285 patients with ASR resurfacing or replacement were studied. Patient and implant characteristics were analysed using univariate and multivariate analyses. RESULTS: 111 (39%) had revision surgery. Time since index surgery (p<0.001), acetabular inclination (p<0.001), their interaction (p<0.001) and femoral head size (p = 0.01) were significant variables. Head size (≤51 mm) had lower Co and Cr levels (p = 0.01). Cr/Co showed marginal decrease over time in the unrevised group and no decrease prerevision. CONCLUSIONS: Repeated measurement of ion-levels were higher in the revision group suggesting that serial measurements rather than absolute values may have a role to play in predicting implant failure.

The effect of acetabular inclination on metal ion levels following metal-on-metal hip arthroplasty.

Acetabular inclination angles have been suggested as a principal determinant of circulating metal ion levels in metal-on-metal hip arthroplasties. We aimed to determine whether inclination angle correlates with ion levels in arthroplasties using the Articular Surface Replacement (ASR) system. Patients undergoing ASR arthroplasties had blood metal ion levels and radiograph analysis performed a mean of 3.2 years after surgery. Inclination angle showed only a weak correlation with cobalt (r=0.21) and chromium (r=0.15) levels. The correlation between inclination angle and cobalt levels was significant only with small femoral components, although it was still weak. Multiple regression showed a complex interaction of factors influencing ion levels but inclination angle accounted for little of this variation. We conclude that the acetabular inclination angle is not a meaningful determinant of metal ion levels in ASR arthroplasties.

Recombinant human bone morphogenetic protein-2 for treatment of open tibial fractures: a prospective, controlled, randomized study of four hundred and fifty patients.

BACKGROUND: The treatment of open fractures of the tibial shaft is often complicated by delayed union and nonunion. The objective of this study was to evaluate the safety and efficacy of the use of recombinant human bone morphogenetic protein-2 (rhBMP-2; dibotermin alfa) to accelerate healing of open tibial shaft fractures and to reduce the need for secondary intervention. METHODS: In a prospective, randomized, controlled, single-blind study, 450 patients with an open tibial fracture were randomized to receive either the standard of care (intramedullary nail fixation and routine soft-tissue management [the control group]), the standard of care and an implant containing 0.75 mg/mL of rhBMP-2 (total dose of 6 mg), or the standard of care and an implant containing 1.50 mg/mL of rhBMP-2 (total dose of 12 mg). The rhBMP-2 implant (rhBMP-2 applied to an absorbable collagen sponge) was placed over the fracture at the time of definitive wound closure. Randomization was stratified by the severity of the open wound. The primary outcome measure was the proportion of patients requiring secondary intervention because of delayed union or nonunion within twelve months postoperatively. RESULTS: Four hundred and twenty-one (94%) of the patients were available for the twelve-month follow-up. The 1.50-mg/mL rhBMP-2 group had a 44% reduction in the risk of failure (i.e., secondary intervention because of delayed union; relative risk = 0.56; 95% confidence interval = 0.40 to 0.78; pairwise p = 0.0005), significantly fewer invasive interventions (e.g., bone-grafting and nail exchange; p = 0.0264), and significantly faster fracture-healing (p = 0.0022) than did the control patients. Significantly more patients treated with 1.50 mg/mL of rhBMP-2 had healing of the fracture at the postoperative visits from ten weeks through twelve months (p = 0.0008). Compared with the control patients, those treated with 1.50 mg/mL of rhBMP-2 also had significantly fewer hardware failures (p = 0.0174), fewer infections (in association with Gustilo-Anderson type-III injuries; p = 0.0219), and faster wound-healing (83% compared with 65% had wound-healing at six weeks; p =0.0010). CONCLUSIONS: The rhBMP-2 implant was safe and, when 1.50 mg/mL was used, significantly superior to the standard of care in reducing the frequency of secondary interventions and the overall invasiveness of the procedures, accelerating fracture and wound-healing, and reducing the infection rate in patients with an open fracture of the tibia.