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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injecting BMAC, a substance derived from bone marrow, improves recovery after hip surgery for a torn labrum (a type of cartilage in the hip). The researchers aim to determine if this treatment can enhance recovery and reduce arthritis symptoms compared to standard surgery alone. Participants will be divided into two groups: one will receive the BMAC treatment, and the other will undergo the usual surgery without it. This trial suits adults needing hip surgery for a labral tear who haven't had previous surgery on the same hip. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bone marrow aspirate concentrate (BMAC) is generally safe for people. Studies have found BMAC effective in treating joint problems, such as cartilage injuries, without major safety concerns. For instance, patients who underwent hip treatments with BMAC reported improved function and recovery.

Although this trial doesn't focus on safety, BMAC's presence in a Phase 3 trial indicates it has already undergone safety testing in earlier stages. This phase typically suggests that any major safety issues have been addressed. Overall, BMAC appears to be a safe option for improving joint health in these procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for acetabular labrum tears, which typically involve hip arthroscopy alone or with basic supportive therapies, Bone Marrow Aspirate Concentrate (BMAC) introduces an innovative approach. BMAC is derived from the patient's own bone marrow and is rich in growth factors and stem cells, which are believed to promote healing and tissue regeneration. Researchers are excited about BMAC because it harnesses the body’s natural healing processes, potentially enhancing recovery and improving outcomes compared to traditional treatment methods.

What evidence suggests that this trial's treatments could be effective for acetabular labrum tear?

In this trial, participants will be randomly assigned to receive either bone marrow aspirate concentrate (BMAC) or standard care during their hip surgery for acetabular labrum tears. Research has shown that BMAC can enhance recovery after hip surgery for joint tears. Studies have found that BMAC improves movement and daily activity in patients with cartilage injuries. Specifically, patients who underwent labral repair with BMAC reported significant improvements in mobility and daily tasks. BMAC aids healing and protects the joint from further damage. These findings suggest that BMAC could be a promising option for more effective recovery after hip surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Scott D. Martin, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12198464/

Bone marrow aspirate concentrate adjunct for acetabular ... The objective of this study was to determine the effect of bone marrow aspirate concentrate (BMAC) on long-term patient outcomes when used ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03909139

Use of BMAC With Hip Arthroscopy Treatment of FAI and ... Within the technical constraints of the hip joint, bone marrow aspirate concentrate is feasible and potentially efficacious option for the treatment of chondral ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212628724005838

Bone Marrow Aspirate Concentrate Harvest and Delivery ... The use of bone marrow aspirate concentrate (BMAC) showed greater functional improvement in patients with moderate cartilage injuries who had a labral repair ...

4. journals.lww.com journals.lww.com/jbjsjournal/fulltext/2022/01050/functional_outcomes_of_arthroscopic_acetabular.2.aspx

Functional Outcomes of Arthroscopic Acetabular Labral... Patients with moderate cartilage injury undergoing arthroscopic acetabular labral repair with BMAC application reported significantly greater functional ...

5. jbjs.org jbjs.org/reader.php?rsuite_id=3070238&type=pdf&name=JBJS.20.01740.pdf

Functional Outcomes of Arthroscopic Acetabular Labral ... To provide symptom relief and improve outcomes in these patients, bone marrow aspirate concentrate (BMAC) has been applied as an adjuvant therapy with the hope ...