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A Phase 2, Multicenter, Single-Blind, Randomized, Stratified, Standard-of-Care Controlled, Feasibility and Safety Study of rhBMP-2/CPM as an Adjuvant Therapy for Fractures of the Proximal Femur

Update Il y a 5 ans
Reference: EUCTR2006-001832-34

Woman and Man

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Extract

To demonstrate the safety of administering rhBMP-2/CPM (either 1.0 mg/mL or 2.0 mg/mL) as an adjunct to internal fixation in subjects with fractures of the proximal femur. The key safety outcome is the incidence of secondary fracture displacement among subjects treated with rhBMP-2/CPM and those receiving standard surgical treatment (internal fixation) alone.

Inclusion criteria

  • Closed fracture of the proximal femur

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