BMAC for Acetabular Labrum Tear

(PRP; PPP; BMAC Trial)

Overseen By Scott D. Martin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Massachusetts General Hospital

Disqualifiers: Non-English speaking, Prior hip surgery

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day (surgical procedure)

160 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to assess the effect of PRP/PPP/BMAC application on functional outcomes after hip arthroscopy to address acetabular labral pathologies. The main questions it aims to answer are: 1. Does PRP/PPP/BMAC application improve functional outcomes after hip arthroscopy to address acetabular labral pathologies? 2. Does PRP/PPP/BMAC application reduce the arthritic burden as measured by functional outcomes following hip arthroscopy to address labral pathologies with concomitant PRP/PPP/BMAC application?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bone Marrow Aspirate Concentrate (BMAC) for acetabular labrum tear?

Research shows that using BMAC during hip arthroscopy for labral tears can lead to similar improvements in patients with early degenerative changes compared to those without arthritis, suggesting potential benefits in symptom relief and outcomes. ^{1 2 3 4 5}

How does the BMAC treatment for acetabular labrum tear differ from other treatments?

BMAC (bone marrow aspirate concentrate) is unique because it uses stem cells from the patient's own bone marrow to potentially repair and regenerate damaged tissue in the hip, which may help improve outcomes in patients with labral tears and early degenerative changes. Unlike other treatments, BMAC is applied during hip arthroscopy and aims to introduce healing cells directly to the affected area without the need for additional surgeries or donor tissue. ^{2 4 6 7 8}

Research Team

Scott D. Martin, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 who need hip arthroscopy to fix a labral pathology in the hip and can understand and sign consent. It's not for those who don't speak English, have had previous surgery on the same hip, or cannot be randomly assigned to treatment groups.

Inclusion Criteria

I need hip surgery to fix a labral tear, as recommended by the study's lead doctor.

I am willing to join the study and can sign the consent form.

Exclusion Criteria

I have had surgery on the same hip before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hip arthroscopy with or without PRP/PPP/BMAC application

1 day (surgical procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using PROMs

24 months

Regular intervals at 3, 6, 12, and 24 months

Long-term Follow-up

Participants continue to be monitored for long-term outcomes up to 20 years

20 years

Treatment Details

Interventions

• Bone marrow aspirate concentrate (BMAC)
• Control

Trial Overview The study tests if PRP (Platelet-Rich Plasma), PPP (Platelet-Poor Plasma), or BMAC (Bone Marrow Aspirate Concentrate) improve how well patients do after hip surgery for labral tears in the acetabulum. Patients are randomly given either a control treatment or BMAC.

Participant Groups

Group I: Bone marrow aspirate concentrate (BMAC) Experimental Treatment 1 Intervention

Patients randomly allocated to receive BMAC will undergo hip arthroscopy and will receive PRP/PPP/BMAC application through the PI's standardized method of harvest, processing, and application.

Group II: Control Placebo Group 1 Intervention

Patients allocated to the control cohort will receive standard of care hip arthroscopy without PRP/PPP/BMAC application.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

In a study of 29 patients who underwent both labral repair and reconstruction, primary labral repair had a failure rate of 31%, while labral reconstruction showed no failures, indicating that reconstruction may be a more reliable option for hip labral issues.

Despite the higher failure rate for labral repair, patient-reported outcomes such as pain levels and satisfaction were similar between the two groups for those who did not experience failure, suggesting that both procedures can lead to good clinical results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral Hip Arthroscopy: Direct Comparison of Primary Acetabular Labral Repair and Primary Acetabular Labral Reconstruction. White, BJ., Patterson, J., Herzog, MM.[2022]

Intra-articular injection of bone marrow aspirate concentrate (BMAC) during hip arthroscopy for patients with symptomatic labral tears and early degenerative changes led to significant improvements in patient-reported outcomes (PROs) over 2 years, comparable to patients with nonarthritic hips.

Despite the improvements, the BMAC group had a higher rate of conversion to total hip arthroplasty (14.3%) compared to the control group (5.7%), although this difference was not statistically significant, indicating that while BMAC may improve symptoms, it does not necessarily reduce the need for further surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hip Arthroscopy With Bone Marrow Aspirate Injection for Patients With Symptomatic Labral Tears and Early Degenerative Changes Shows Similar Improvement Compared With Patients Undergoing Hip Arthroscopy With Symptomatic Labral Tears Without Arthritis. Day, MA., Hancock, KJ., Selley, RS., et al.[2023]

In a study of 3,684 patients undergoing arthroscopic labral procedures, both labral repair and debridement significantly improved hip function at 12 months, as measured by the iHOT-12 questionnaire, with no significant difference in outcomes between the two methods after adjusting for various factors.

Overall, 66% of patients achieved the minimum clinically important difference in their hip function, indicating that both procedures are effective options for improving early outcomes after hip arthroscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of early outcomes of arthroscopic labral repair or debridement : a study using the UK Non-Arthroplasty Hip Registry dataset. Holleyman, RJ., Lyman, S., Bankes, MJK., et al.[2022]

In a study of 124 patients undergoing arthroscopic acetabular labral repair, those who received bone marrow aspirate concentrate (BMAC) showed significantly greater functional improvements at 12 and 24 months compared to those who did not receive BMAC, particularly in patients with moderate cartilage damage.

While BMAC did not show a significant difference in overall outcomes for all patients, it provided notable benefits for those with moderate cartilage injury, suggesting its potential as an effective adjuvant therapy in this specific group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. Martin, SD., Kucharik, MP., Abraham, PF., et al.[2023]

Labral tears in the acetabular region can lead to pain, mechanical symptoms, and potentially accelerate the development of arthritis, highlighting the importance of labral preservation for joint health.

There are three main treatment options for labral tears—repair, débridement, and reconstruction—each with its own advantages and disadvantages, necessitating a refined decision-making process for optimal patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Making for Labral Treatment in the Hip: Repair Versus Débridement Versus Reconstruction. Domb, BG., Hartigan, DE., Perets, I.[2022]

The use of bone marrow aspirate concentrate (BMAC) during hip arthroscopy can effectively introduce mesenchymal stem cells to the chondrolabral junction, potentially improving repair outcomes without the complications associated with traditional donor-site procedures.

This method allows for a reproducible technique to enhance labral repairs while minimizing surgery time and avoiding donor-site morbidity, addressing a significant challenge in treating damage to the chondrolabral junction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. Stelzer, JW., Martin, SD.[2022]

A study with a 2-year follow-up found that patients with early joint degeneration (Tönnis grade 1 or 2) who received bone marrow aspirate concentrate (BMAC) injections after hip arthroscopy showed improvements in outcomes comparable to nonarthritic patients (Tönnis 0) with labral tears.

This suggests that BMAC may help patients with early degenerative changes in the hip achieve functional outcomes similar to those without arthritis, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Hip Arthroscopy in Patients With Early Degeneration Who Receive Intra-Articular Bone Marrow Aspirate Concentrate Can Achieve Outcomes Similar to Nonarthritic Patients. Hartwell, MJ., Zhang, AL.[2023]

In a preliminary study involving 5 patients, the use of ultrasound-guided autologous bone marrow aspirate concentrate (BMAC) injections showed technical success with no procedural complications, indicating a safe method for treating musculoskeletal conditions.

Four out of five patients reported symptomatic improvement after BMAC injections for various conditions, suggesting that this treatment may be effective, although the long-term efficacy and safety still need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Ultrasound-Guided Musculoskeletal Applications of Autologous Bone Marrow Aspirate Concentrate: Preliminary Experience From a Single Institution. Garwood, ER., Burke, CJ., Jazrawi, LM., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bilateral Hip Arthroscopy: Direct Comparison of Primary Acetabular Labral Repair and Primary Acetabular Labral Reconstruction. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Hip Arthroscopy With Bone Marrow Aspirate Injection for Patients With Symptomatic Labral Tears and Early Degenerative Changes Shows Similar Improvement Compared With Patients Undergoing Hip Arthroscopy With Symptomatic Labral Tears Without Arthritis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of early outcomes of arthroscopic labral repair or debridement : a study using the UK Non-Arthroplasty Hip Registry dataset. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Functional Outcomes of Arthroscopic Acetabular Labral Repair with and without Bone Marrow Aspirate Concentrate. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Decision Making for Labral Treatment in the Hip: Repair Versus Débridement Versus Reconstruction. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Use of Bone Marrow Aspirate Concentrate with Acetabular Labral Repair for the Management of Chondrolabral Junction Breakdown. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Hip Arthroscopy in Patients With Early Degeneration Who Receive Intra-Articular Bone Marrow Aspirate Concentrate Can Achieve Outcomes Similar to Nonarthritic Patients. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Percutaneous Ultrasound-Guided Musculoskeletal Applications of Autologous Bone Marrow Aspirate Concentrate: Preliminary Experience From a Single Institution. [2019]