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NCT03909139 · ClinicalTrials.gov registry record
Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear
A clinical trial of Femoro Acetabular Impingement and Chondral Defect, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- 400
- Enrollment target
- 1
- Study location
NCT03909139 is a study of Femoro Acetabular Impingement and Chondral Defect that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 400 participants, above the 117-participant average among 3 other Femoro Acetabular Impingement trials with a reported enrollment target (242% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03909139, a study of Femoro Acetabular Impingement and Chondral Defect, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- 400 participants
- Enrollment target
- 1
- Study location
Study Summary
Femoro-acetabular impingement is a well known cause of damage to the acetabular labrum and chondrolabral junction. Additionally, it has been proposed that disruption of hip biomechanics resulting from a labral tear causes a faster progression towards osteoarthritis (OA). This progression has been observed to begin with breakdown of the chondrolabral junction with later development of diffuse osteoarthritis. Use of hip arthroscopy has increased dramatically in recent years to treat symptomatic labral tears and potentially avoid the morbidity and cost associated with hip osteoarthritis. Correction of labral pathology presents a technical challenge and many techniques currently exist. Increased understanding of the structure-functional relationship dictated by labral anatomy has led to the development of methods aimed at restoring functional anatomy by re-establishing the labrum's native position and contour on the rim of the acetabulum. Therefore, akin to repairing a torn meniscus in the knee, restoring the anatomic footprint of a torn labrum will reconstitute normal joint biomechanics. Despite the advances in techniques for labral repair, strategies for mitigating or repairing damage to the chondrolabral junction do not yet exist. This area has been shown to consist of hyaline and fibro cartilage. Many techniques for cartilage repair exist, although most are not feasible due to technical challenges specific to the hip joint. The management of articular cartilage defects is one of the most challenging clinical problems for orthopaedic surgeons. Articular cartilage has a limited intrinsic healing capacity, and pathology frequently results in gradual tissue deterioration. Currently, the standard surgical intervention for end-stage degenerative joint pathology is total joint replacement. Early surgical interventions for symptomatic cartilage lesions including cell based therapies such as autologous chondrocyte implantation (ACI), bone marrow aspirate concentrate (BMAC
Conditions Studied
Interventions
- BIOLOGICAL BMAC
Study Locations (1)
Massachusetts
- MGH, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2019-09-06 |
| Est. Completion | 2027-06-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03909139
The ClinicalTrials.gov registry entry for NCT03909139 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 117-participant average among 3 other Femoro Acetabular Impingement trials with a reported enrollment target (242% higher). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Femoro Acetabular Impingement appearing as the primary indexed condition, and to 1 intervention - of which BMAC is the first listed.
NCT03909139 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03909139 about?
NCT03909139 is a clinical study titled "Use of BMAC With Hip Arthroscopy Treatment of FAI and Labral Tear". Femoro-acetabular impingement is a well known cause of damage to the acetabular labrum and chondrolabral junction. Additionally, it has been proposed that disruption of hip biomechanics resulting from a labral tear causes a faster progression towards osteoarthritis (OA). This progression has been ob...
What is the current status of trial NCT03909139?
This trial is currently recruiting. The enrollment target is 400 participants. The study started on 2019-09-06. Estimated completion is 2027-06-30.
What conditions does trial NCT03909139 study?
This clinical trial studies the following conditions: Femoro Acetabular Impingement, Chondral Defect, Acetabular Labrum Tear, Bone Marrow Aspirate Concentrate, Mesenchymal Stromal Cell.
What interventions are being tested in trial NCT03909139?
The interventions under investigation include: BMAC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03909139?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03909139 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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