NCT01828905
Completed
N/A
A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures
Johannes Gutenberg University Mainz16 sites in 1 country137 target enrollmentApril 2013
ConditionsAO 41-B2 and AO 41-B3 Tibia Fractures
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- AO 41-B2 and AO 41-B3 Tibia Fractures
- Sponsor
- Johannes Gutenberg University Mainz
- Enrollment
- 137
- Locations
- 16
- Primary Endpoint
- SF-12 Physical Component Summary (PCS) at week 26
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The aim of the study is to compare fracture healing, quality of life, pain, and cost of care of the use of CERAMENT™|BONE VOID FILLER as bone graft substitute to the use of autologous cancellous bone graft (iliac crest) in the treatment of patients with tibia fractures treated by internal fixation and void reconstruction.
Investigators
Univ.-Prof. Pol M. Rommens
Head of Department of Trauma Surgery, Director of the Center for Musculoskeletal Surgery
Johannes Gutenberg University Mainz
Eligibility Criteria
Inclusion Criteria
- •patients with traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 \& B3)
- •solitary trauma
- •candidate for bone grafting
- •patients between the age of 18 and 65 years
- •written informed consent obtained before any study-related activities
- •patients with communicative ability to understand the procedure and participate in the study and comply with the follow up program
Exclusion Criteria
- •patients with multiple injuries
- •polytrauma patients
- •compartment syndrome
- •previous iliac crest bone graft harvesting
- •local infection at the site of implantation
- •chronic pain disease
- •malignancy
- •rheumatoid arthritis
- •chronic cortisone intake
- •X-ray diagnostics not available, fracture cannot be classified
Outcomes
Primary Outcomes
SF-12 Physical Component Summary (PCS) at week 26
Time Frame: 26 weeks
Global pain VAS score at week 26
Time Frame: 26 weeks
Secondary Outcomes
- SF-12 PCS and MCS at visit 5(6 weeks)
- Utilisation of costs of care related resources(26 weeks)
- SF-12 PCS and MCS at visit 4(1 week)
- Bone healing(1, 6, 12 and 26 weeks)
- SF-12 PCS and MCS at visit 6(12 weeks)
- SF-12 PCS and MCS at visit 7(26 weeks)
Study Sites (16)
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