Closed diaphyseal tibial fracture MedDRA version: 8.1 Level: LLT Classification code 10043827 Term: Tibia fracture
Conditions
Sponsors
Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject’s signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures are performed. 2. Closed diaphyseal tibial fracture, Orthopaedic Trauma Association (OTA) classification 42A, 42B, or 42C. 3. Age > or =18 years and skeletally mature. 4. Closed reduction and definitive internal fracture fixation by means of a reamed, locked intramedullary (IM) nail within 72 hours after injury (SOC for the purpose of this study is defined as meeting these criteria). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concurrent fractures of the ipsilateral or contralateral lower extremity other than the ipsilateral fibula, that would impede performance on the functional assessment of full weight bearing (FWB). 2. Planned procedure(s) that stimulate fracture healing after IM nailing. 3. Impending compartment syndrome before randomization. 4. Pathological fractures, except if due to postmenopausal or senile osteoporosis. 5. History of other metabolic bone disorders that may affect the region under study (eg, Paget’s disease, renal osteodystrophy, or benign tumor). 6. Documented history of malignancy, except basal or squamous cell carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To demonstrate a reduction of time to fracture union based on assessments of radiographs by a central evaluation committee (CEC). 2. To demonstrate acceleration of return to normal function based on the time to full weight bearing (FWB) without pain at the fracture site, as established by the investigator.;Secondary Objective: 1. To demonstrate safety of rhBMP-2/CPM administration including key safety outcomes. 2. To demonstrate earlier return to function with the Short Musculoskeletal Function Assessment (SMFA). 3. Assess feasibility of rhBMP-2/CPM administration;Primary end point(s): The primary efficacy variables for the trial stem from radiographic, and functional assessments aimed at evaluating the key fracture outcomes of fracture union and restoration of functional mobility. Fracture union is the first co-primary endpoint. It will be determined from radiographic assessments by a CEC masked to treatment assignment. Fracture union is defined as the presence of callus bridging the fracture line(s) and/or obliteration (disappearance) of the fracture line(s) visualized on at least 3 of 4 diaphyseal aspects on orthogonal radiographic views. Bridging callus is defined as the appearance of mineralized callus, spanning the proximal and distal fracture fragments. Bridging callus should be sufficiently mineralized such that it remains visible on follow-up radiographs, without regression, thereby supporting the diagnosis of “fracture union”. Obliteration (disappearance) of the fracture lines refers to endosteal bone remodeling and should not be mistaken with obliteration by non-bony substances (eg, CPM). The second co-primary endpoint is subject’s ability to bear pain free full body weight on the affected limb. This indicates the subject’s ability to use the fractured limb for its normal function. The investigator will establish this endpoint. The secondary efficacy variable is the postoperative return to normal function assessed by means of a self- | — |
Countries
Bulgaria, Finland, France, Germany, Latvia, Slovenia, Sweden, United Kingdom
Outcome results
None listed