Clinical trial NCT05017961: Comparing Efficacy of Bone Marrow Aspirate Concentrate (BMAC) Combined With Allograft in Treatment of Calcaneus Fractures
Official title: Randomized Prospective Cohort Study Comparing Efficacy of Bone Marrow Aspirate Concentrate Combined With Cryopreserve Allograft Bone in the Treatment of Intra-Articular Calcaneal Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fractures, Bone
Keywords: calcaneus fracture
bone graft
bone marrow aspirate
stem cells
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of BMAC when used in conjunction with viable allograft bone for treating displaced intra-articular calcaneal fractures, in terms of rate of allograft incorporation into the host tissue, bone healing, and functional outcome.

Detailed description: The study group will consist of patients with intra-articular calcaneal fractures admitted to our academic level I trauma center that underwent open reduction internal fixation. Inclusion criteria will be patients with a closed displaced intra-articular fracture Sanders type III without any evidence of neurovascular injury. Patients will be randomly divided into three groups according to the plan of management: autograft alone, viable allograft combined with BMAC, or viable allograft alone. Radiographic imaging and three-dimensional standing computed tomography will be used to assess the articular surface, Bohler's angle, the crucial angle of Gissane, and the height, width and length of the calcaneus. The American Orthopedic Foot and Ankle Society (AOFAS) ankle-hind-foot scoring system and visual analog scale (VAS) will be used to post-operative evaluation of the patients.

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.

Primary outcomes:
measure: Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
timeFrame: baseline to 6 weeks
measure: Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
timeFrame: baseline to 12 weeks
measure: Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
timeFrame: baseline to 24 weeks
measure: Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system
timeFrame: baseline to 52 weeks
measure: Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)
timeFrame: baseline to 6 weeks
measure: Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)
timeFrame: baseline to 12 weeks
measure: Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)
timeFrame: baseline to 24 weeks
measure: Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)
timeFrame: baseline to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: