AO 41-B2 and AO 41-B3 Tibia Fractures
Conditions
Keywords
tibia fracture, bone graft, iliac crest, bone graft substitute, Cerament, void filler, quality of life, pain, costs of care
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.
Interventions
DEVICECERAMENT™|BONE VOID FILLER
ceramic bone void filler
PROCEDUREAutologous cancellous bone graft
autologous cancellous bone graft
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global pain VAS score at week 26 | 26 weeks |
| SF-12 Physical Component Summary (PCS) at week 26 | 26 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 PCS and MCS at visit 4 | 1 week | — |
| Bone healing | 1, 6, 12 and 26 weeks | Evaluated by X-ray |
| SF-12 PCS and MCS at visit 6 | 12 weeks | — |
| SF-12 PCS and MCS at visit 7 | 26 weeks | — |
| SF-12 PCS and MCS at visit 5 | 6 weeks | — |
| Utilisation of costs of care related resources | 26 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurence of adverse events, device complaints and device-related incidents | 26 weeks | Frequencies of subjects experiencing at least one adverse event (AE) will be displayed by body system and preferred term according to MedDRA terminology. Detailed information collected for each AE will include: a description of the event, duration, whether the AE was serious, intensity, relationship to trial device, action taken, clinical outcome. Summary tables will present the number of subjects observed with AEs and corresponding percentages. Number of device complaints and device-related incidents (AE related to the trial device) respectively as well as the frequencies of occurences of these events in both groups will be calculated. |
Countries
Germany
Outcome results
None listed