Use of Graft Jacket for Rotator Cuff Repair
Public ClinicalTrials.gov record NCT00456781. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
GraftJacket® Rotator Cuff Tendon Reinforcement Scaffold: A Randomized Prospective Clinical Evaluation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00456781
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 79 participants
Conditions and interventions
Conditions
Interventions
- Augmentation Device
- Rotator Cuff Repair without augmentation Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2007 (Type not available)
- Primary completion
- Apr 2009 (Actual)
- Completion
- Mar 2011 (Actual)
- Last update posted
- Jul 3, 2014
2007 – 2011
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Orthopedic Institute | Simi Valley | California | 93063 | — |
| Bone and Joint Clinic of Houston | Houston | Texas | 77005 | — |
| Kelsey-Seybold Orthopedic | Houston | Texas | 77025 | — |
| Plano Orthopedic & Sports Medicine | Plano | Texas | 75093 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00456781, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 3, 2014 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00456781 live on ClinicalTrials.gov.