Status:
COMPLETED
Use of Graft Jacket for Rotator Cuff Repair
Lead Sponsor:
Stryker Trauma and Extremities
Collaborating Sponsors:
Sports Medicine & Arthroscopic Surgery Bone & Joint Clinic of Houston
Southern California Orthopedic Institute Medical Group
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 Techno...
Detailed Description
This is a prospective multi-center clinical study evaluating GraftJacket in the augmentation of large and massive rotator cuff tears compared to the traditional surgical technique of sutures and ancho...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00456781
Start Date
April 1 2007
End Date
March 1 2011
Last Update
July 3 2014
Active Locations (7)
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1
Southern California Orthopedic Institute
Simi Valley, California, United States, 93063
2
Bone and Joint Clinic of Houston
Houston, Texas, United States, 77005
3
Kelsey-Seybold Orthopedic
Houston, Texas, United States, 77025
4
Plano Orthopedic & Sports Medicine
Plano, Texas, United States, 75093