Cerament Treatment of Fracture Defects (CERTiFy)

Johannes Gutenberg University (JGU)

Status: Completed

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

Treatments: Device: CERAMENT™|BONE VOID FILLER; Procedure: Autologous cancellous bone graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01828905

S041/2012

Details and patient eligibility

About

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.

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Cerament

Experimental group

Description:

CERAMENT™\|BONE VOID FILLER as bone graft substitute

Treatment:

Device: CERAMENT™|BONE VOID FILLER

Bone graft

Active Comparator group

Description:

Autologous cancellous bone graft (iliac crest)

Treatment:

Procedure: Autologous cancellous bone graft