Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Stryker Trauma and Extremities.
NCT00456781 is a NA study that has completed, run by Stryker Trauma and Extremities. The registered enrollment target is 79 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
each subject will be eligible for the study based on the Pre-operative results of the MRI as it relates to the size of the tissue tear. The subjects will be assigned to either the tissue scaffold material or the standard surgical suture or anchors. Then, the procedure to repair is determined by the investigator as an arthoscopic or open procedure. Pos-operative evalutions via MRI will be obtained throughout the study to evaluate the effectiveness of the surgical procedure and for the measurement
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 |
What the finished NCT00456781 record still lists
NCT00456781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Augmentation is the first listed.
NCT00456781 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00456781's enrollment target sits among peer trials
79 1060th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05798897 · 79 participants · Phase 1
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
- NCT06042439 · 79 participants · NA
AM vs PM Exercise Training
- NCT06223555 · 79 participants · NA
Variability In Mixed Meal Tests: Fixed Versus Adjusted to Energy Needs Caloric Dose
- NCT01243931 · 80 participants · NA
Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia