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

Phase 1

• Conditions: Closed diaphyseal tibial fracture; MedDRA version: 8.1Level: LLTClassification code 10043827Term: Tibia fracture

• Registration Number: EUCTR2006-001831-23-FR
• Lead Sponsor: Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-11-30
• Study Completion: 2010-03-30
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified