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NCT00456781 · ClinicalTrials.gov registry record · NA
Use of Graft Jacket for Rotator Cuff Repair
A NA study, sponsored by Stryker Trauma and Extremities.
- Completed
- Registry status
- NA
- Development phase
- 79
- Enrollment target
NCT00456781 is a NA study that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 79 participants.
The verdict
NCT00456781, a NA study, has completed, sponsored by Stryker Trauma and Extremities.
- COMPLETED
- Registry status
- NA
- Development phase
- 79 participants
- Enrollment target
Study Summary
This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpose of this study is to determine whether rotator cuff repair augmentation using GraftJacket allograft provides a viable alternative, based on observed clinical outcomes, versus outcomes traditionally achieved with suture and anchor repairs. The study will secondarily investigate the difference in outcomes in patients treated arthroscopically versus open. This study will report patient progress and results at early (6 month) and late (2 year) time points in patients treated for large and massive reparable rotator cuff tears (\>3cm). A reparable tear is defined as a tear of the rotator cuff where it is possible to bring the retracted tendon edge back to the greater tuberosity of the humerus without excessive tension. Restoration of rotator cuff integrity, clinical outcomes and re-tear rate will be included in the study evaluations.
Interventions
- DEVICE Augmentation
- PROCEDURE Rotator Cuff Repair without augmentation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2007-04 |
| Est. Completion | 2011-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00456781
The ClinicalTrials.gov registry entry for NCT00456781 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stryker Trauma and Extremities, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Augmentation is the first listed.
NCT00456781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00456781 about?
NCT00456781 is a clinical study titled "Use of Graft Jacket for Rotator Cuff Repair". This study is to evaluate the safety and effectiveness of GraftJacket, a human tissue product used in fixing large and massive reparable rotator cuff tears.GraftJacket allograft (Wright Medical Technology, Inc., Arlington, TN) is a biologic tissue that is derived from human dermis. The primary purpo...
What is the current status of trial NCT00456781?
This trial is currently completed. It is a NA study. The enrollment target is 79 participants. The study started on 2007-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00456781?
The interventions under investigation include: Augmentation (DEVICE), Rotator Cuff Repair without augmentation (PROCEDURE).
Who is sponsoring clinical trial NCT00456781?
This trial is sponsored by Stryker Trauma and Extremities, which has 30 total clinical trials registered on ClinicalTrials.gov.
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