A Phase 2/3, Multicenter, Double-Blind, Randomized, Controlled Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP 2)/Calcium Phosphate Matrix (CPM) in Closed Diaphyseal Tibial Fractures

Wyeth Pharmaceuticals Inc.0 个研究点目标入组 600 人开始时间: 2008年9月19日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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 (closed epiphysis).
•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

•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 that has been treated and has fully resolved for a minimum of 5 years.
•7. Retained surgical hardware in the tibia under study due to a previous fracture.

发起方