Femoroacetabular impingement.
Asheesh Bedi, Bryan T Kelly
https://pubmed.ncbi.nlm.nih.gov/23283377Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06003101
Effect of Platelet-Rich Plasma, Platelet-Poor Plasma, and Bone Marrow Aspirate Concentrate Application on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies: A Prospective Randomized Controlled Trial
Led by Massachusetts General Hospital · Updated on 2024-11-20
160
Participants Needed
1
Research Sites
939 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 PRP/PPP/BMAC 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 PRP/PPP/BMAC and form a control group, while those with more significant damage will be randomized to either receive PRP/PPP/BMAC 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
Brief Title
Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically indicated for hip arthroscopy to address a labral pathology
- Willingness to participate and be randomized to either treatment group
- Ability to understand and sign the informed consent document
You will not qualify if you...
- Not able to complete surveys in English
- Prior surgery on the same hip, including hip arthroscopy or osteotomies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
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)
Post-operative Follow-up
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
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
S
Scott D. Martin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Arthroscopic labral repair in the hip: surgical technique and review of the literature.
Brian T Kelly, Daniel E Weiland, Mara L Schenker...
https://pubmed.ncbi.nlm.nih.gov/16376242What factors influence long-term survivorship after hip arthroscopy?
Joseph C McCarthy, Bryan T Jarrett, Olumide Ojeifo...
https://pubmed.ncbi.nlm.nih.gov/20872105The Otto E. Aufranc Award: The role of labral lesions to development of early degenerative hip disease.
J C McCarthy, P C Noble, M R Schuck...
https://pubmed.ncbi.nlm.nih.gov/11764355The acetabular labrum seal: a poroelastic finite element model.
S J Ferguson, J T Bryant, R Ganz...
https://pubmed.ncbi.nlm.nih.gov/10771126An in vitro investigation of the acetabular labral seal in hip joint mechanics.
S J Ferguson, J T Bryant, R Ganz...
https://pubmed.ncbi.nlm.nih.gov/12547354The influence of the acetabular labrum on hip joint cartilage consolidation: a poroelastic finite element model.
S J Ferguson, J T Bryant, R Ganz...
https://pubmed.ncbi.nlm.nih.gov/10828325Arthroscopic management of femoroacetabular impingement: early outcomes measures.
Christopher M Larson, M Russell Giveans
https://pubmed.ncbi.nlm.nih.gov/18442686Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated With Femoroacetabular Impingement: Updated Mean 7-Year Follow-up.
Christopher M Larson, Robert S Dean, Rebecca Stone McGaver...
https://pubmed.ncbi.nlm.nih.gov/35099305Arthroscopic debridement versus refixation of the acetabular labrum associated with femoroacetabular impingement: mean 3.5-year follow-up.
Christopher M Larson, M Russell Giveans, Rebecca M Stone
https://pubmed.ncbi.nlm.nih.gov/22307078