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Procedure

BMAC for Acetabular Labrum Tear (PRP; PPP; BMAC Trial)

Phase 3

Recruiting

Led By Scott D. Martin, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months

Awards & highlights

PRP; PPP; BMAC Trial Summary

This trial will assess if PRP/PPP/BMAC application improves functional outcomes and reduces arthritis burden after hip arthroscopy for labral pathologies.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, treatments like PRP/PPP/BMAC may cause discomfort at injection sites, possible infection risk, swelling, and bruising related to the procedure.

PRP; PPP; BMAC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-operative), 3 months, 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hip Outcome Score (HOS)

International Hip Outcome Tool-12 (iHOT-12)

Kerlan-Jobe Orthopaedic Clinic Athletic Hip Score

+4 more

Secondary outcome measures

Oswestry Low Back Disability Questionnaire (aka Oswestry Disability Index, ODI)

Patient Satisfaction, Postoperative Protocol Compliance, & Subsequent Surgeries

Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)

+2 more

PRP; PPP; BMAC Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Bone marrow aspirate concentrate (BMAC)Experimental Treatment1 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: ControlPlacebo Group1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,934 Previous Clinical Trials

13,198,421 Total Patients Enrolled

Scott D. Martin, MDPrincipal InvestigatorMassachusetts General Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are currently involved in the research?

"Affirmative. Clinicaltrials.gov has published information suggesting that this medical trial, which was originally posted on August 30th 2023, is currently enrolling participants. It seeks 160 individuals from a single site for study inclusion."

Answered by AI

Are there still vacancies in this research program for participants?

"Affirmative. According to information found on clinicaltrials.gov, recruitment for this medical trial is still ongoing. It was first posted on August 30th 2023 and the latest update was made on August 18th 2023; 160 patients from a single site need to be enrolled in order for it to succeed."

Answered by AI

What potential risks are associated with Bone marrow aspirate concentrate (BMAC) usage?

"Our evaluation resulted in a score of 3 for the safety of Bone marrow aspirate concentrate (BMAC), as multiple rounds of clinical data has validated its efficacy."

Answered by AI

What key aims are being sought through this medical experiment?

"This clinical trial will track the Modified Harris Hip Score (mHHS) over a Baseline, 3 month, 6 month, 12 month and 24 months period as its primary outcome. Secondary outcomes that are being measured include Tegner Lysholm Knee Scoring Scale which is expressed in the form of a Validated PROM to assess knee pain with scores ranging from 0-100; Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10), an evaluation tool designed to capture a patient's overall health status via 10 questions presented on 5 point rating scales whose responses can be used to calculate two summary scores:"

Answered by AI

Recent research and studies

Clinical Orthopaedics & Related ResearchJournal

What Factors Influence Long-term Survivorship After Hip Arthroscopy?

McCarthy, Joseph C., Bryan T. Jarrett, Olumide Ojeifo, Jo Ann Lee, and Charles R. Bragdon. 2011. “What Factors Influence Long-term Survivorship After Hip Arthroscopy?”. Clinical Orthopaedics & Related Research. Ovid Technologies (Wolters Kluwer Health). doi:10.1007/s11999-010-1559-2.

The American Journal of Sports MedicineJournal

Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated with Femoroacetabular Impingement

Larson, Christopher M., M. Russell Giveans, and Rebecca M. Stone. 2012. “Arthroscopic Debridement Versus Refixation of the Acetabular Labrum Associated with Femoroacetabular Impingement”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546511434578.

clinicaltrials.govStudy

Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies

Scott D Martin 2023. "Effect of PRP, PPP, & BMAC on Functional Outcomes Following Hip Arthroscopy for Acetabular Labral Pathologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06003101.