Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.
Hofmann Alexander,Gorbulev Stanislav,Guehring Thorsten,Schulz Arndt Peter,Schupfner Rupert,Raschke Michael,Huber-Wagner Stefan,Rommens Pol Maria,
The Journal of bone and joint surgery. American volume
BACKGROUND:Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT). METHODS:In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs. RESULTS:Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups. CONCLUSIONS:Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3. LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
Comparison of autogenous bone graft and endothermic calcium phosphate cement for defect augmentation in tibial plateau fractures. A multicenter, prospective, randomized study.
Russell Thomas A,Leighton Ross K,
The Journal of bone and joint surgery. American volume
BACKGROUND:Bone graft augmentation is often selected to treat defects associated with unstable tibial plateau fractures. This prospective, randomized, multicenter study was undertaken to determine the efficacy of bioresorbable calcium phosphate cement compared with standard autogenous iliac bone graft in the treatment of these osseous defects. METHODS:One hundred and twenty acute, closed, unstable tibial plateau fractures (Schatzker types I through VI) in 119 adult patients were prospectively enrolled in twelve study sites in North America between 1999 and 2002. Randomization for the type of grafting of the subarticular defect was done at the time of surgery, with use of a 2:1 ratio, to treatment with calcium phosphate cement (eighty-two fractures) or autogenous iliac bone graft (thirty-eight fractures). After open reduction, standard plate-and-screw or screw-only fixation was used and then either the cement or the bone graft was placed in the defect cavity for subarticular support. Follow-up included standard radiographs, evaluated by multiple reviewers to avoid bias, and knee range-of-motion assessment at six months to one year or later. RESULTS:The age, weight, height, and sex of the patients and the fracture patterns were comparable in the two groups, as were union rates and time to union. There was a significantly (p = 0.009) higher rate of articular subsidence during the three to twelve-month follow-up period in the bone graft group. CONCLUSIONS:The bioresorbable calcium phosphate cement used in this study appears to be a better choice, at least in terms of the prevention of subsidence, than autogenous iliac bone graft for the treatment of subarticular defects associated with unstable tibial plateau fractures. LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.
CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures.
Nusselt Thomas,Hofmann Alexander,Wachtlin Daniel,Gorbulev Stanislav,Rommens Pol Maria
BACKGROUND:Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). METHODS/DESIGN:CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. DISCUSSION:CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT01828905.