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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.

ABSTRACT: 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)).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.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.ClinicalTrials.gov: NCT01828905.

SUBMITTER: Nusselt T

PROVIDER: S-EPMC3975294 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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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 T Hofmann Alexander A Wachtlin Daniel D Gorbulev Stanislav S Rommens Pol Maria PM

Trials 20140308

<h4>Background</h4>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 ...[more]

PMID: 24606670

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Project description:Introduction and importance: Unicondylar tibial plateau fractures with tibial shaft fractures are extremely rare among the elderly group of people. The traditional treatment method is to apply double plates to fix unicondylar tibial plateau fractures combined with tibial shaft fractures respectively, but this fixation method can disrupt the blood supply around the soft tissues and increase the rate of postoperative infection and fracture non-union. In this paper, we would analyse an old unicondylar tibial plateau fracture (Schatzker type III) with tibial shaft fracture which admitted to our department and discussed the efficacy of using intramedullary nails and plates in the treatment of these fractures. Case presentation A 78-year-old woman with an old unicondylar tibial plateau fracture combined with tibial shaft fracture was presented in this case. Using an intramedullary nail combined with a plate to achieve good results. Clinical discussion This case represents a rare case of an unicondylar tibial plateau fracture with a tibial shaft fracture. In this case, the tibial plateau fracture was first incised and internally fixed with a 9-hole plate across the fracture line of the tibial shaft, followed by fixing the tibial shaft fracture with an intramedullary nail. This treatment helped us successfully reset the unicondylar tibial plateau fracture with tibial shaft fracture and provided a satisfactory outcome for the patient. Conclusion Using intramedullary nails combined with plates to treat unicondylar tibial plateau fractures with tibial shaft fractures allowed for a predictable healing result. Highlights • Unicondylar tibial plateau fractures with tibial shaft fractures are extremely rare in the elderly.• Traditional double plate internal fixation seriously affected soft tissue and bone healing.• The use of plates in combination with intramedullary nails can reduce the destruction of soft tissue and fix both the tibial plateau and the tibial shaft.

Project description:The most commonly accepted system of classification for tibia plateau fractures is that of Schatzker. Increasingly, both high energy injuries and atypical osteoporotic fragility failures have led to more complex, unusual and previously undescribed fracture patterns being recognized. We present a case of a patient with a previously unreported pattern of tibia plateau fracture and knee dislocation. We highlight the challenges confronted and present the management and the outcomes of his injury. A 28-year old male motorcyclist was involved in a head on collision with a truck and was transferred by helicopter to our level 1 major trauma centre emergency department. His injuries were a circumferential degloving injury to his left leg and a right lateral tibial plateau fracture/knee dislocation. The pattern of the lateral tibial plateau fracture was unique and did not fit any recognised classification system. The patient received a spanning external fixator initially and after latency of 12 days for soft tissue resuscitation he underwent definite fixation through an antero-lateral approach to the proximal tibia with two cannulated 6.5 mm partially threaded screws and an additional lateral proximal tibia plate in buttress mode. A hinged knee brace was applied with unrestricted range of motion post-operatively and free weight bearing were permitted post operatively. At the 6 months follow up, the patient walks without aids and with no limp. Examination revealed a stable joint and full range of motion. Plain radiographs revealed that the fracture healed with good alignment and the fixation remained stable. High energy injuries can lead to more complicated fracture patterns, which challenge the orthopaedic surgeons in their management. It is crucial to understand the individual fracture pattern and the possible challenges that may occur. This study reports a lateral tibia plateau fracture/dislocation which perhaps is best described as a reverse Schatzker IV type fracture.

Project description:PurposeTo examine the condition and triggers of stress fractures of the lateral tibial plateau (LTP) similar to type III lateral hinge fractures (LHFs) after open wedge high tibial osteotomy (OWHTO).MethodsOWHTO was performed in 118 knees. They were examined for LHFs by computed tomography (CT). Patients were divided into the stress fracture group (Group SF) if they showed fracture lines on CT performed after starting weight-bearing walking and the normal group (Group N) for others.ResultsThe mean age was significantly older in Group SF (P = 0.022). Preoperatively, Group SF showed a significantly higher tibio-femoral angle (TFA, P = 0.014). No significant differences were observed in TFA and weight-bearing line ratio after surgery. Correction angle was significantly higher in the SF group. And all of the SF were more than 13 degrees. There was no significant difference in LHF incidence between groups, whereas stress fracture incidence differed significantly for each type of LHF (chi-squared test, P = 0.0001): 14.6% of type I cases, 100% of type II cases, 0% of type III cases, and 6.1% of those without LHF.DiscussionThe load on the LTP is assumed to act as a shearing force in type II fractures, which may contribute greatly to stress fractures. In type III, stress fractures may not occur because of the load dispersed at the fracture part. The stress fracture site is similar to type III LHF, and this kind of fracture is thought to be a delayed type III because it occurs after patients start weight-bearing walking. Moreover, they are observed in type I cases with a stable hinge and in 6% of cases without LHF. This study showed that high varus knees corrected with a large correction angle may develop stress fractures. OWHTO requires attention to stress fractures of the LTP, which can be regarded as delayed type III, in those developing LHFs postoperatively or having a high varus knee preoperatively.ConclusionThese results indicated the possibility of stress fracture in LTP during weight-bearing exercise after OWHTO, which was regarded as a delayed type III fracture. The results showed that Correction angle was more than 13 degrees, and lateral hinge fracture type II of the Takeuchi classification was an inducement of this stress fracture.Level of evidenceLevel IV.

Project description: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.

Dataset Information

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.

Publications

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.

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