Outcomes in Rotator Cuff Repair Using Graft Reinforcement

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.

Key facts

Study ID

NCT01025037

Run by

Stryker Trauma and Extremities

People needed

61

Starts

2009-10-01

Expected to finish

2014-04-01

Last updated by the study team

2015-01-26

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient:
• is an adult male or female between the ages of 40-70 years old;
• has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm;
• requires surgical repair of single rotator cuff (i.e. one limb);
• has movement of the non-operative arm defined as shoulder elevation of equal to or greater than 90 degrees and is able to perform postoperative exercises;
• is able to return for all scheduled and required study visits;
• is able to provide written informed consent for study participation.

You may not qualify if…

• The patient:
• has irreparable large rotator cuff tears that are found intra-operatively. Note: irreparable is defined by the inability to approximate the tendon to the tuberosity without tension;
• has a rotator cuff tear < 3cm (measured intra-operatively);
• has a rotator cuff tear > 5cm (measured intra-operatively);
• has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
• has grade 3 or 4 fatty infiltration of the rotator cuff;
• has had prior surgical repair to the affected shoulder;
• is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I);
• is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study.
• has lower limb injuries requiring walking assist devices such as crutches and walkers;
• has a known collagen disorder, including systemic lupus erythematous (SLE), rheumatoid arthritis (RA), polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome.
• has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon;
• has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection;
• has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction;
• is enrolled or plans to enroll in another clinical trial during this study that would affect the patient's safety or results of this trial;
• has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate.
• has an inability to have a closed MRI conducted.
• needs a re-operation for a re-tear of the rotator cuff.

Where it is running

• Orthopaedic Clinical Association — Phoenix, Arizona, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Duke University Medical Center — Durham, North Carolina, United States
• OrthoNeuro — New Albany, Ohio, United States
• Rotheman Institute — Philadelphia, Pennsylvania, United States
• West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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