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NCT03909178 · ClinicalTrials.gov registry record · NA
Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum
A NA study of Osteoarthritis, Hip and Hip Arthroscopy, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- NA
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT03909178: Active NA study of Osteoarthritis, Hip and Hip Arthroscopy, sponsored by Massachusetts General Hospital.
NCT03909178 is a NA study of Osteoarthritis, Hip and Hip Arthroscopy that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 110 participants, below the 1,268-participant average among 20 other Osteoarthritis, Hip trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03909178, a NA study of Osteoarthritis, Hip and Hip Arthroscopy, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for performing labral repair in an asymptomatic patient despite the many postulated biomechanical benefits that an intact labrum imparts to the hip joint. Representing a smaller proportion of all tears, symptomatic tears of the acetabular labrum present a therapeutic challenge. Current treatment modalities range from conservative measures to open surgical intervention. Conservative measures have typically included: activity modification, the use of non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy (PT), core strengthening and improvement of sensory motor control. In the past two decades, technological advances in the form of surgical instrumentation and traction devices have facilitated less invasive arthroscopic techniques to diagnose and treat hip problems and as such is now the preferred treatment modality for many orthopedic surgeons treating patients with hip pathology. Determining which patients, using age and arthritic burden as predictors, can benefit from labral repair is paramount for several reasons. Showing arthroscopic repair is of little or no benefit to a specific cohort can reduce the number of unnecessary surgeries performed, increase the use of conservative therapy (if validated) and reduce the interval between diagnosis and total hip replacement.
Primary Outcome
Full Name of Outcome: modified Harris Hip Score (mHHS) Purpose: Validated Hip Patient Reported Outcome Measurements (PROMs) to assess the patient's functional outcomes post-surgery. Scale of mHHS: Min: 0 Max: 100 Higher score indicates better hip functionally. No subscores or subscales. The mean changes in scores required to achieve a minimically clinically important difference is 6.9.
Conditions Studied
Interventions
- PROCEDURE Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group)
- PROCEDURE Physical Therapy Focused on the Hip and Hemi-pelvis (PT group)
Study Locations (1)
Massachusetts
- MGH, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2013-10-21 |
| Est. Completion | 2030-06 |
| Phase | NA |
What the registry record for NCT03909178 still lists
NCT03909178 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 1,268-participant average among 20 other Osteoarthritis, Hip trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Osteoarthritis, Hip appearing as the primary indexed condition, and to 2 interventions - of which Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group) is the first listed.
NCT03909178 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03909178 about?
NCT03909178 is a clinical study titled "Arthroscopic Labral Repair Versus Physical Therapy for Tears of the Acetabular Labrum". Tears of the acetabular labrum appear to be common with the prevalence of asymptomatic tears in the general population approaching 66% and 70% based on cadaveric dissection and magnetic resonance imaging, respectively. Despite this prevalence, there is no currently accepted justification for perform...
What is the current status of trial NCT03909178?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 110 participants. The study started on 2013-10-21. Estimated completion is 2030-06.
What conditions does trial NCT03909178 study?
This clinical trial studies the following conditions: Osteoarthritis, Hip, Hip Arthroscopy, Physical Therapy, Femoroacetabular Impingement, Acetabular Labrum Tear.
What interventions are being tested in trial NCT03909178?
The interventions under investigation include: Hip Arthroscopy Surgery with Acetabular Labral Repair (SPT group) (PROCEDURE), Physical Therapy Focused on the Hip and Hemi-pelvis (PT group) (PROCEDURE).
Who is sponsoring clinical trial NCT03909178?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03909178 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03909178's enrollment target sits among peer trials
110 12th of 20 higher than 9 of 20 other Osteoarthritis, Hip trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Hip trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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