Comparing Efficacy of Bone Marrow Aspirate Concentrate (BMAC) Combined With Allograft in Treatment of Calcaneus Fractures (BMAC)
Fractures, Bone
About this trial
This is an interventional treatment trial for Fractures, Bone focused on measuring calcaneus fracture, bone graft, bone marrow aspirate, stem cells
Eligibility Criteria
Inclusion Criteria:
- Closed displaced intra-articular fracture without any evidence of nerve or blood vessel injury, the fractures belonged to Sanders type III according to Sanders classification and amenable to open reduction internal fixation
- Life expectancy of at least 1 year
- Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
- Adequate soft tissue coverage at the fracture site through primary closure.
- Unilateral or bilateral calcaneal fractures.
Exclusion Criteria:
- Pregnant or breastfeeding women or planning on becoming pregnant during the investigational period
- Patient is currently participating in an investigational drug or other device study or previously enrolled in this study.
- Uncontrolled diabetes mellitus (hemoglobin A1c levels > 10%)
- A current endocrine or metabolic disorder known to affect osteogenesis
- Currently has untreated malignant neoplasm(s), or is currently undergoing radiation therapy or chemotherapy.
- Inadequate neurovascular status in the involved limb that may jeopardize healing.
- Patients who have a preexisting calcaneus deformity that cannot accommodate a reduction or a previous history of osteomyelitis in the index limb.
- Other ipsilateral lower extremity fracture(s) if, in the opinion of the investigator, the treatment and/or rehabilitation of such fracture(s) will substantially interfere with the treatment, rehabilitation or other requirements outlined in this protocol.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Other
Other
Autograft
Allograft only
Allograft combined with BMAC
Following definitive fracture reduction a bone defect often remained in the substance of the calcaneus beneath the reduced posterior facet. In this group an autograft will be used to fill the void. For the purpose of autologous grafting, cancellous strips of bone will be harvested from the posterior superior iliac crest or proximal tibia. It shall be applied wherever bone loss exists as a result of the incident fracture or subsequent bone debridement(s). This will be the control arm.
Following definitive fracture reduction a bone defect often remained in the substance of the calcaneus beneath the reduced posterior facet. In this group a cryopreserved allograft bone (Musculoskeletal Tissue Foundation, New Jersey, NJ) will be used to fill the void. It shall be applied wherever bone loss exists as a result of the incident fracture or subsequent bone debridement(s).
Following definitive fracture reduction a bone defect often remained in the substance of the calcaneus beneath the reduced posterior facet. In this group a cryopreserved allograft bone (Musculoskeletal Tissue Foundation, New Jersey, NJ) combined with BMAC will be used to fill the void. For the purpose of BMAC preparation, bone marrow will be collected from iliac crest or proximal tibia. It shall be applied wherever bone loss exists as a result of the incident fracture or subsequent bone debridement(s).