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NCT02256891 · ClinicalTrials.gov registry record · Phase 4
Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique
A Phase 4 study of Rotator Cuff Tear, sponsored by HealthPartners Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
- 1
- Study location
NCT02256891: Completed Phase 4 study of Rotator Cuff Tear, sponsored by HealthPartners Institute.
NCT02256891 is a Phase 4 study of Rotator Cuff Tear that has completed, run by HealthPartners Institute. The registered enrollment target is 97 participants, above the 85-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (14% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02256891, a Phase 4 study of Rotator Cuff Tear, has completed, sponsored by HealthPartners Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other technique is the standard double row repairs utilizing medial and laterally based anchor fixation with the use of plateley rich fibrin membrane (PRFM). It is hypothesized that patients undergoing the surgery with the PRFM will report a higher quality of life than the patients that do not receive this treatment.
Primary Outcome
The Western Ontario Rotator Cuff Index total score is on a scale of 0-2100; where 0 is the best score and 2100 is the score. There is a discrepancy between overall number of participants analyzed for this measure when compared to the participant flow module. More patients completed a baseline measure than those that completed the entire study.
Conditions Studied
Interventions
- DEVICE PRFM
- PROCEDURE Double Row
Study Locations (1)
Minnesota
- TRIA Orthopaedic Center - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-12 |
| Phase | Phase 4 |
What the finished NCT02256891 record still lists
NCT02256891 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, above the 85-participant average among 11 other Rotator Cuff Tear trials with a reported enrollment target (14% higher).
The record links to 1 condition, with Rotator Cuff Tear appearing as the primary indexed condition, and to 2 interventions - of which PRFM is the first listed.
NCT02256891 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02256891 about?
NCT02256891 is a clinical study titled "Rotator Cuff Repair Using Standard Double Row Technique With Platelet Rich Fibrin Membrane vs. Standard Double Row Technique". This study is a single-blind, randomized study evaluating the 6 month and 2 year outcomes of patients treated with arthroscopic rotator cuff repair using one of two techniques. One technique used is the standard double row repairs utilizing medial and laterally based anchor fixation and the other te...
What is the current status of trial NCT02256891?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2011-07. Estimated completion is 2015-12.
What conditions does trial NCT02256891 study?
This clinical trial studies the following conditions: Rotator Cuff Tear.
What interventions are being tested in trial NCT02256891?
The interventions under investigation include: PRFM (DEVICE), Double Row (PROCEDURE).
Who is sponsoring clinical trial NCT02256891?
This trial is sponsored by HealthPartners Institute, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02256891 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02256891's enrollment target sits among peer trials
97 4th of 11 higher than 8 of 11 other Rotator Cuff Tear trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tear 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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