Femoroacetabular impingement.
Asheesh Bedi, Bryan T Kelly
https://pubmed.ncbi.nlm.nih.gov/23283377/Actively Recruiting
Led by Massachusetts General Hospital · Updated on 2024-11-20
160
Participants Needed
1
Research Sites
939 weeks
Total Duration
Researchers are evaluating the effect of applying a combination of platelet-rich plasma PRP, platelet-poor plasma PPP, and bone marrow aspirate concentrate BMAC on functional outcomes after hip arthroscopy for acetabular labral pathologies. The study aims to determine whether this application improves patient-reported outcomes and reduces arthritic burden in patients undergoing surgery for labral tears and cartilage damage. This randomized controlled trial offers level I evidence to compare standard hip arthroscopy with and without PRPPPPBMAC application. Participants will undergo hip arthroscopy under general anesthesia, where the surgeon will assess damage to the labrum and cartilage. Patients with minimal damage will receive standard care without PRPPPPBMAC and form a control group, while those with more significant damage will be randomized to either receive PRPPPPBMAC application or no additional treatment. Bone marrow will be aspirated from the ilium through arthroscopic portals during surgery for those in the treatment group. Participants will be blinded to their treatment allocation. Throughout the study, participants will complete various patient-reported outcome measures, including pain assessments and hip function scores, before surgery and at intervals up to 24 months and beyond. The study will also track physical exams, imaging results, and any subsequent surgeries. Follow-up will continue for up to 20 years postoperatively, with surveys collected via email or phone to monitor long-term outcomes and safety.
CONDITIONS
Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies
S
Scott D. Martin, MD
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Massachusetts General Hospital
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | BMAC + Arthroscopy | Standard Arthroscopy |
|---|---|---|
| What is it? | Hip arthroscopy with intraoperative bone marrow aspirate concentrate (BMAC) applied to the surgical site. | Standard hip arthroscopy performed without the addition of bone marrow aspirate concentrate. |
| Role in the trial | Investigational treatment arm, evaluating if BMAC improves post-surgical functional outcomes. | Comparator arm representing standard hip arthroscopy without BMAC. |
| Primary intended use | To evaluate whether adding BMAC during hip arthroscopy improves pain, hip function, and recovery in adults with labral tears. | To provide the comparison for standard outcomes after arthroscopy for labral tears, without additional BMAC. |
| How it is given or performed | During arthroscopy, bone marrow is aspirated from the ilium and introduced to the surgical field using an established technique. | Standard hip arthroscopy is performed according to established procedural protocols, without bone marrow aspiration. |
| What is the current evidence? | BMAC is an area of active research with some prior single-center retrospective studies showing similar functional improvement and patient-reported outcomes compared to standard repair alone. Prospective randomized evidence is limited and the benefit remains inconclusive. | Standard arthroscopy for labral pathology is supported by established literature, showing significant improvement in pain and function, with durability into mid- and longer-term follow-up. |
| Important limitations | BMAC approach requires an additional intraoperative aspiration procedure. Current evidence consists mainly of retrospective studies; prospective, randomized data regarding improved outcomes is still lacking. | While standard arthroscopy is effective, some patients may not achieve full pain relief, and there is a risk of postoperative stiffness or need for revision surgery. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo hip arthroscopy for acetabular labral pathologies. Those randomized to the treatment group receive application of platelet-rich plasma, platelet-poor plasma, and bone marrow aspirate concentrate (BMAC) during surgery. Bone marrow is aspirated through arthroscopic portals as part of the procedure. Participants are blinded to their treatment allocation.
1 surgical visit (in-person)
Duration - Up to 24 months and beyond
Participants complete patient-reported outcome measures and clinical assessments to track their functional progress and recovery following surgery.
Visits at 3 months, 6 months, 12 months, and 24 months post-surgery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34648479/Massachusetts General Hospital
Lead Sponsor