Intraoperative Bone Marrow Aspirate Concentrate Injections: Evaluating Outcomes in a Randomized Controlled Trial

NCT06750757 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: AHI-006
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if bone marrow aspirate concentrate (BMAC) used with your hip arthroscopy surgery is a better treatment than just having surgery alone for treatment of labral tears in your hip. BMAC is an injection, where your doctor will insert a needle into your hip and harvest the bone marrow that is located inside of your bones. This will be performed under anesthesia during your hip arthroscopy surgery and will be injected during the procedure. BMAC is an FDA approved procedure and has had many research articles produced from it. Researchers will compare patients who received BMAC during their surgery to those who have not to determine if the injection with surgery is better than surgery alone.

Conditions

Labral Tear; Femoroacetabular Impingement

Keywords

hip arthroscopy; bone marrow aspirate concentrate; orthobiologics

Outcome Measures

Primary Outcomes (1)

• iHOT-12

  2 years

Secondary Outcomes (4)

• modified Harris Hip Score

  2 years

• Non-arthritic hip score

  2 years

• Hip outcome score-sports specific subscale

  2 years

• Visual analog scale

  2 years

Study Arms (2)

BMAC Arm

EXPERIMENTAL

Biological: Bone marrow aspirate concentrate; Procedure: Hip arthroscopy

No BMAC (Control)

ACTIVE COMPARATOR

Procedure: Hip arthroscopy

Interventions

Bone marrow aspirate concentrate BIOLOGICAL

145cc of BMAC/PRP/PPP injection.

Also known as: BMAC

BMAC Arm

Hip arthroscopy PROCEDURE

Both groups will undergo a hip arthroscopy to treat their condition. However, the control group will not receive a BMAC injection during the surgery.

BMAC Arm; No BMAC (Control)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary hip arthroscopy to treat femoroacetabular impingement
• Subjects will require a clinical diagnosis of intra-articular pathology consisting of anterior hip and/or groin pain with restricted hip motion and positive impingement testing.

You may not qualify if:

• Patients who have had prior hip arthroscopy or hip surgery, Tonnis grade II or higher radiographic osteoarthritis, congenital hip deformities including Legg-Calve-Perthes or Slipped Capital Femoral Epiphysis, rheumatologic conditions, or workers compensation claims.
• Patients undergoing additional arthroscopic procedures such as trochanteric bursectomy or gluteus medius repair will also be excluded.

Sponsors & Collaborators

• American Hip Institute: lead

Related Publications (41)

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MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexandra Mantice

CONTACT

8472829808; foundation@americanhipinstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share