Cerament Treatment of Fracture Defects

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multicenter, Randomized Study Investigating the Use of CERAMENT™|BONE VOID FILLER as Bone Graft Substitute in Tibia Plateau Fractures

Conditions
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AO 41-B2 and AO 41-B3 Tibia Fractures

Intervention / Treatment
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* Device: CERAMENT™|BONE VOID FILLER
* Procedure: Autologous cancellous bone graft


Participation Criteria
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Eligibility Criteria
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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 clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation a pre-existing calcium metabolism disorder (e.g. hypercalcemia) known hyperthyroidism or autonomous thyroid adenoma history of serious reaction to iodine based radio contrast agents women who are pregnant or breastfeeding irreversible coagulopathy or bleeding disorder history of physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications history of hypersensitivity to the investigational device or any of its ingredients participation in other clinical trials during the present clinical trial or within the last 1 month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cerament<br>CERAMENT™|BONE VOID FILLER as bone graft substitute | Device: CERAMENT™|BONE VOID FILLER<br>* ceramic bone void filler<br>|
| Active Comparator: Bone graft<br>Autologous cancellous bone graft (iliac crest) | Procedure: Autologous cancellous bone graft<br>* autologous cancellous bone graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 Physical Component Summary (PCS) at week 26 |  | 26 weeks | 
| Global pain VAS score at week 26 |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utilisation of costs of care related resources |  | 26 weeks | 
| SF-12 PCS and MCS at visit 4 |  | 1 week | 
| Bone healing | Evaluated by X-ray | 1, 6, 12 and 26 weeks | 
| SF-12 PCS and MCS at visit 5 |  | 6 weeks | 
| SF-12 PCS and MCS at visit 6 |  | 12 weeks | 
| SF-12 PCS and MCS at visit 7 |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tibia fracture, bone graft, iliac crest, bone graft substitute, Cerament, void filler, quality of life, pain, costs of care