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NCT03494660 · ClinicalTrials.gov registry record
SCP Hip Outcomes Study
A clinical trial of Femoroacetabular Impingement and Avascular Necrosis of Hip, sponsored by Zimmer Biomet.
- Active
- Registry status
- 82
- Enrollment target
- 6
- Study locations
NCT03494660: Active study of Femoroacetabular Impingement and Avascular Necrosis of Hip, sponsored by Zimmer Biomet.
NCT03494660 is a study of Femoroacetabular Impingement and Avascular Necrosis of Hip that is active but no longer recruiting, run by Zimmer Biomet. The registered enrollment target is 82 participants, below the 1,360-participant average among 8 other Femoroacetabular Impingement trials with a reported enrollment target (94% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03494660, a study of Femoroacetabular Impingement and Avascular Necrosis of Hip, is active but no longer recruiting, sponsored by Zimmer Biomet.
- ACTIVE NOT RECRUITING
- Registry status
- 82 participants
- Enrollment target
- 6
- Study locations
Study Summary
Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity levels and patient satisfaction.
Primary Outcome
Change in Modified Harris Hip Score using a 0-100 overall score, from baseline at 2-years. Subscales of pain, function, and activity levels are combined to generate the overall score. Pain is scored out of 44 possible points, function is scored out of 33 possible points and subject activities are scored out of 14 possible points. The maximum score of 91 is multiplied by 1.1 to give a total score out of 100; a higher score represents better patient reported pain, function and activity levels.
Conditions Studied
Interventions
- DEVICE Subchondroplasty Procedure with AccuFill
Study Locations (6)
Ohio
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
California
- Eisenhower Desert Orthopedic Center - Rancho Mirage
Florida
- Andrews Research & Education Foundation - Gulf Breeze
Illinois
- OrthoIllinois - Rockford
Kentucky
- University of Kentucky Research Foundation - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2025-12 |
What the registry record for NCT03494660 still lists
NCT03494660 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 1,360-participant average among 8 other Femoroacetabular Impingement trials with a reported enrollment target (94% lower).
The record links to 7 conditions, with Femoroacetabular Impingement appearing as the primary indexed condition, and to 1 intervention - of which Subchondroplasty Procedure with AccuFill is the first listed.
NCT03494660 lists 6 locations in 5 states (Ohio, California, Florida).
Frequently Asked Questions
What is clinical trial NCT03494660 about?
NCT03494660 is a clinical study titled "SCP Hip Outcomes Study". Post-market clinical outcomes study to collect data on the short- and long-term outcomes for subjects who are undergoing or have undergone the Subchondroplasty® (SCP®) Procedure in the hip in a standard clinical setting. Outcomes to be assessed include medication usage, pain, function, activity leve...
What is the current status of trial NCT03494660?
This trial is currently active not recruiting. The enrollment target is 82 participants. The study started on 2018-03-27. Estimated completion is 2025-12.
What conditions does trial NCT03494660 study?
This clinical trial studies the following conditions: Femoroacetabular Impingement, Avascular Necrosis of Hip, Bone Marrow Edema, Dysplasia; Hip, Subchondral Cysts.
What interventions are being tested in trial NCT03494660?
The interventions under investigation include: Subchondroplasty Procedure with AccuFill (DEVICE).
Who is sponsoring clinical trial NCT03494660?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03494660 being conducted?
This trial has 6 study locations across California, Florida, Illinois, Kentucky, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03494660's enrollment target sits among peer trials
82 5th of 8 higher than 4 of 8 other Femoroacetabular Impingement trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Femoroacetabular Impingement 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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