Use of Graft Jacket for Rotator Cuff Repair

Launched by STRYKER TRAUMA AND EXTREMITIES · Apr 4, 2007

Keywords

ClinConnect Summary

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 anchors alone. The study group will consist of 160 patients (early withdrawals or drop outs will not be replaced). Surgical approach for each patient will be either mini-open or arthroscopic. Safety assessments for this clinical study will be based on reported adverse events. Any adverse event that occurs during the study that represents a change from the patient's condition as noted at baseline \[d...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients between the ages of 18 - 75 years inclusive,
• • 2. Reads, understand and able to complete the patient reported outcomes in English,
• • 3. Patients with large and massive rotator cuff tears of more than 3cm, which can be repaired either arthroscopically or by open surgery.,
• • 4. Patients with either primary or revision rotator cuff tears measuring \< 5cm with at least 2 tendon involvement as indicated by MRI,
• • 5. 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,
• • 6. Patients for whom there is a reasonable expectation that he or she will be available for each protocol required post-operative follow-up examination,
• • 7. 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 Criteria:
• • 1. Patients with irreparable large or massive rotator cuff tears \<3cm will be excluded if found intra-operatively
• • 2. Patients with rotator cuff tears where the subscapularis tendon is disrupted,
• • 3. Patients with inflammatory or auto-immune based joint diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
• • 4. 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,
• • 5. Patients who smoke,
• • 6. Patients with a documented history of drug abuse within six months of treatment,
• • 7. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment.
• • 8. Females of child-bearing potential who are pregnant or breastfeeding, or plan to become pregnant during the course of the study