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

NCT05017961 | Withdrawn FDA Device

• 1 other identifier: IRB-300003034
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fractures, Bone

Keywords

calcaneus fracture; bone graft; bone marrow aspirate; stem cells

Outcome Measures

Primary Outcomes (8)

• Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system

  The AOFAS ankle-hindfoot scoring system is the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The scoring system range is from 0 to 100 with 100 being the best outcome score.

  baseline to 6 weeks

• Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system

  The AOFAS ankle-hindfoot scoring system is the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The scoring system range is from 0 to 100 with 100 being the best outcome score.

  baseline to 12 weeks

• Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system

  The AOFAS ankle-hindfoot scoring system is the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The scoring system range is from 0 to 100 with 100 being the best outcome score.

  baseline to 24 weeks

• Percentage of participant with satisfactory bone healing using American Orthopedics Foot and Ankle Society (AOFAS) ankle-hindfoot scoring system

  The AOFAS ankle-hindfoot scoring system is the most commonly used instruments for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It combines a clinician-reported and a patient-reported part. The scoring system range is from 0 to 100 with 100 being the best outcome score.

  baseline to 52 weeks

• Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)

  The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Scale ranges from 0 to 10 with 10 being worse.

  baseline to 6 weeks

• Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)

  The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Scale ranges from 0 to 10 with 10 being worse.

  baseline to 12 weeks

• Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)

  The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Scale ranges from 0 to 10 with 10 being worse.

  baseline to 24 weeks

• Percentage of patient with satisfactory post treatment pain with Visual Analogue Scale (VAS)

  The visual analogue scale or visual analog scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. Scale ranges from 0 to 10 with 10 being worse.

  baseline to 52 weeks

Study Arms (3)

Autograft

ACTIVE COMPARATOR

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.

Device: Autograft

Allograft only

OTHER

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).

Device: Allograft only

Allograft combined with BMAC

OTHER

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).

Device: Allograft combined with BMAC

Interventions

Autograft DEVICE

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.

Autograft

Allograft only DEVICE

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.

Allograft only

Allograft combined with BMAC DEVICE

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.

Allograft combined with BMAC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Fractures, Bone

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Michael Johnson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: July 10, 2019
• Primary Completion: July 10, 2019
• Study Completion: July 10, 2019
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share