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Clinical trial

Effect of Platelet-Rich Plasma, Platelet-Poor Plasma, & Bone Marrow Aspirate Concentrate Application on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies: A Prospective Randomized Controlled Trial

ID
Name
2023P001436
Description
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?
Trial arms
Trial start
2023-08-30
Estimated PCD
2027-08-30
Trial end
2045-08-30
Status
Recruiting
Phase
Early phase I
Treatment
Bone marrow aspirate concentrate (BMAC)
Bone marrow aspiration from the body of the ilium will be performed through one of the arthroscopic portals.
Arms:
Bone marrow aspirate concentrate (BMAC)
Control
Standard of care hip arthroscopy without bone marrow aspiration will be performed in these patients.
Arms:
Control
Size
160
Primary endpoint
Pain Level
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Modified Harris Hip Score (mHHS)
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
International Hip Outcome Tool-12 (iHOT-12)
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Non-Arthritic Hip Score (NAHS)
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Hip Outcome Score (HOS)
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Visual Analog Scale (VAS) Pain Score
Baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months
Eligibility criteria
Inclusion Criteria: * Age: \> or equal to 18 years * Clinically indicated for hip arthroscopy (by the study PI) to address a labral pathology * Willingness to participate, amenable to randomization into either treatment arm of the research study, and the ability to understand \& sign the informed consent document Exclusion Criteria: * Non-English speaking (PROM surveys are only validated in English) * Prior same site (i.e., ipsilateral hip) surgery, including but not limited to previous hip arthroscopy, core decompression, or periacetabular osteotomies
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2023-10-05

1 organization

1 product

4 indications

Organization
Massachusetts General Hospital
Product
Bone marrow aspirate concentrate
Indication
labral tear
Indication
Femoroacetabular Impingement
Indication
Chondral Defect
Indication
Bone Marrow Aspirate Concentrate