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NCT01621893 · ClinicalTrials.gov registry record
Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions
A clinical trial of Bone Marrow Edema, sponsored by Zimmer Biomet.
- Completed
- Registry status
- 70
- Enrollment target
- 6
- Study locations
NCT01621893: Completed study of Bone Marrow Edema, sponsored by Zimmer Biomet.
NCT01621893 is a study of Bone Marrow Edema that has completed, run by Zimmer Biomet. The registered enrollment target is 70 participants. The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621893, a study of Bone Marrow Edema, has completed, sponsored by Zimmer Biomet.
- COMPLETED
- Registry status
- 70 participants
- Enrollment target
- 6
- Study locations
Study Summary
Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.
Primary Outcome
Post-operative KOOS pain subsection score at 1-Year follow-up is improved by at least 10 points. The KOOS is a validated instrument which measures knee pain and function using five subscales: pain, symptoms, function in daily living, function in sport and recreation, and quality of life. The instrument consists of 42 standardized questions each having 5 point Likert response scale
Conditions Studied
Interventions
- PROCEDURE Subchondroplasty
Study Locations (6)
Pennsylvania
- Rothman Institute - Philadelphia
- Allegheny Orthopaedic Associates - Pittsburgh
California
- CORE Orthopaedics - Encinitas
Illinois
- Hinsdale Orthopedics - New Lenox
New York
- Hospital for Joint Disease - New York
South Carolina
- Steadman Hawkins Foundation - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2012-03-26 |
| Est. Completion | 2021-05-26 |
What the finished NCT01621893 record still lists
NCT01621893 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target.
The record links to 1 condition, with Bone Marrow Edema appearing as the primary indexed condition, and to 1 intervention - of which Subchondroplasty is the first listed.
NCT01621893 lists 6 locations in 5 states (Pennsylvania, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT01621893 about?
NCT01621893 is a clinical study titled "Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions". Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty procedure including changes in pain, function, and overall health.
What is the current status of trial NCT01621893?
This trial is currently completed. The enrollment target is 70 participants. The study started on 2012-03-26. Estimated completion is 2021-05-26.
What conditions does trial NCT01621893 study?
This clinical trial studies the following conditions: Bone Marrow Edema.
What interventions are being tested in trial NCT01621893?
The interventions under investigation include: Subchondroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT01621893?
This trial is sponsored by Zimmer Biomet, which has 115 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01621893 being conducted?
This trial has 6 study locations across California, Illinois, New York, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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