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NCT01383239 · ClinicalTrials.gov registry record · NA
Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT01383239 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 27 participants.
The verdict
NCT01383239, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of $17,427 per patient in 2004. As the population ages, the number of rotator cuff repair surgeries is increasing; in New York State, rotator cuff repairs increased by 50% over a 5 years span 48. Unfortunately, surgically repaired rotator cuff tears fail in at least 20% and up to 94% of individuals 3, 9, 13, 20, 28, 40, 52, 58. While many non-modifiable variables have been associated with failure of repair, postoperative rehabilitation is a modifiable variable that has received little attention. The investigators propose a multicenter randomized controlled trial to study one important strategy for postoperative rehabilitation: early versus delayed onset of physical therapy. This pilot study will enroll patients with isolated supraspinatus tears who undergo a standard surgical repair technique. The investigators hypothesize that delaying the onset of physical therapy will improve healing and patient outcomes. Our primary outcome variable is the Western Ontario Rotator Cuff (WORC) Index (a disease specific validated outcome measure). Because outcome measures may not always correlate with healing of rotator cuff repairs 50, our secondary outcome measure will be healing based on MRI scans 12 months after surgery.
Interventions
- OTHER Immediate Postoperative Therapy
- OTHER Delayed Physical Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383239
The ClinicalTrials.gov registry entry for NCT01383239 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Immediate Postoperative Therapy is the first listed.
NCT01383239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01383239 about?
NCT01383239 is a clinical study titled "Impact of Postoperative Management on Outcomes and Healing of Rotator Cuff Repairs". Rotator cuff tears are seen in 40% of subjects over age 50 57, with a prevalence known to increase with each decade of life 51. Each year rotator cuff disorders lead to 4.5 million physician visits, 40,000 inpatient surgeries, and 250,000 outpatient surgeries with costs of $17,427 per patient in 200...
What is the current status of trial NCT01383239?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2011-09. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01383239?
The interventions under investigation include: Immediate Postoperative Therapy (OTHER), Delayed Physical Therapy (OTHER).
Who is sponsoring clinical trial NCT01383239?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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