NCT05017961

Comparing Efficacy of Bone Marrow Aspirate Concentrate (BMAC) Combined With Allograft in Treatment of Calcaneus Fractures

Randomized Prospective Cohort Study Comparing Efficacy of Bone Marrow Aspirate Concentrate Combined With Cryopreserve Allograft Bone in the Treatment of Intra-Articular Calcaneal Fractures

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fractures, Bone

Interventions

Type	Name	Description
DEVICE	Autograft	An autograft bone will be harvested from proximal tibia or posterior superior iliac crest. First the bony landmarks of the posterior iliac crest or proximal tibia are palpated. The skin is then injected down to and including the periosteum with 1% lidocaine without epinephrine. After 1 cm skin incision and gentle dissection of subcutaneous soft tissue, the bone harvesting device inserted through the skin and subcutaneous tissues until it reaches the cortical bone. Then, manual pressure is used to position the bone harvesting device against the dense cortical bone. A battery-powered power instrument is then will be used to drill the harvesting device into the medullary cavity. After the harvesting device insertion the cancellous strips of bone will be harvested and applied to the fracture site gap.At the conclusion of autograft bone harvesting procedure, the wound will be closed with 3-0 Nylon and a sterile dressing will be applied to the harvest site.
DEVICE	Allograft only	The jar containing allograft tissue and cryopreservation solution will be placed in a sterile basin containing a warm (35°C to 39°C; 95°F to 102.2°F) sterile irrigant (Normal saline or 5% Dextrose in Lactated Ringer's Solution). The jar containing the allograft will remain in this solution until the contents of the jar flows freely upon inversion. The jar will be removed from the warm solution once free-flowing. Sterile gauze or the optional strainer will be used to decant the cryopreservation solution into a waste container. 5% Dextrose in Lactated Ringer's Solution will be added to the indicated fill line to immerse the allograft tissue. The cap will be replaced and inverted twice to suspend tissue until ready for use. 5% Dextrose will be decanted in Lactated Ringer's Solution prior to use. Implant will be used within 2 hours of thawing.
DEVICE	Allograft combined with BMAC	A bone marrow aspiration kit will be used for bone marrow aspiration. First the bony landmarks of the posterior iliac crest and sacroiliac joint are palpated. The skin is then injected down to and including the periosteum with 1% lidocaine without epinephrine. Then, the bone marrow aspiration trochar and needle are percutaneously inserted through the skin and subcutaneous tis- sues until it reaches the posterior iliac crest. The trajectory of the needle will be parallel to the iliac crest, or perpendicular to the Anterior Superior Iliac Spine (ASIS) or Posterior Superior Iliac Spine (PSIS), depending on the harvest site used. After the trochar is inserted into the posterior iliac crest but prior to aspiration, 1 mL of heparin (1,000 U/mL) will be preloaded into the syringe. Approximately 60 mL of bone marrow will be aspirated, which requires the use of two 30-mL syringes. At the conclusion of BMAC harvesting, a sterile dressing will be applied to the harvest site.

Timeline

• Start date: 2019-07-10
• Primary completion: 2019-07-10
• Completion: 2019-07-10
• First posted: 2021-08-24
• Last updated: 2023-08-01

Regulatory

• FDA-regulated device study