Use of Graft Jacket for Rotator Cuff Repair

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

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.

Key facts

Study ID: NCT00456781
Run by: Stryker Trauma and Extremities
People needed: 79
Starts: 2007-04-01
Expected to finish: 2011-03-01
Last updated by the study team: 2014-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients between the ages of 18 - 75 years inclusive,
Reads, understand and able to complete the patient reported outcomes in English,
Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
Patients with either primary or revision rotator cuff tears measuring < 5cm with at least 2 tendon involvement as indicated by MRI,
Patients who have a reasonable movement of the non-operative arm, defined as a shoulder elevation of equal or more than 90°, and are able to perform (postoperative) exercises,
Patients for whom there is a reasonable expectation that he or she will be available for each protocol required post-operative follow-up examination,
Patients must complete the informed consent process (including any regulatory requirements such as HIPAA authorization) agreeing to participate and signing the informed consent form prior to the site conducting any study related procedures.

You may not qualify if…

Patients with irreparable large or massive rotator cuff tears <3cm will be excluded if found intra-operatively
Patients with rotator cuff tears where the subscapularis tendon is disrupted,
Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
Patients with evidence of active infection, cancer, or highly communicable diseases that would preclude the patient from completing required patient assessments and clinic visits as described in the protocol,
Patients who smoke,
Patients with a documented history of drug abuse within six months of treatment,
Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.
Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study

Where it is running

Southern California Orthopedic Institute — Simi Valley, California, United States
Bone and Joint Clinic of Houston — Houston, Texas, United States
Kelsey-Seybold Orthopedic — Houston, Texas, United States
Plano Orthopedic & Sports Medicine — Plano, Texas, United States
Pan Am Clinic — Winnipeg, Manitoba, Canada
Fowler Kennedy Sport Medicine Clinic — London, Ontario, Canada
The Hand and Upper Limb Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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