A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rotator Cuff Tear
- Sponsor
- Stryker Trauma and Extremities
- Enrollment
- 61
- Locations
- 6
- Primary Endpoint
- Adjusted Constant-Murley Score
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
Detailed Description
Conexa is a surgical mesh derived from porcine dermis and processed to produce an acellular dermal matrix. It is designed to perform as a surgical mesh for use as a soft tissue patch to reinforce soft tissue where weaknesses exist and for the surgical repair of damaged or ruptured soft tissue membranes. The purpose of this post-market clinical study is to collect safety and efficacy data when Conexa is used to repair torn tendons of the rotator cuff. Conexa will be used in accordance with its labeling for this clinical study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Adjusted Constant-Murley Score
Time Frame: baseline, post-op months 6, 12, and 24
The Constant-Murley Shoulder Score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (Activities of Daily Living - sleep, work, recreation/sport) (20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment) (40 points) and strength (25 points), for a total of 65 points (Stiller \& Uhl, 2005).
American Shoulder and Elbow Score (ASES)
Time Frame: baseline, post-op months 3, 6, 12, and 24
The ASES evaluation generally has a patient self-evaluation section and a physician assessment section. The patient self-evaluation section of the form contains visual analog scales for pain, instability, an activities of daily living (ADL) questionnaire. The physician assessment section includes an area to collect demographic information and assesses range of motion, specific physical signs, strength, and stability. A shoulder score can be derived from the visual analogue scale score for pain (50%) and the cumulative activities of daily living score (50%) (Richards, Bigliani, Gartsman, Iannotti, \& Zuckerman, 1994). The ASES evaluation has a total of 100 points possible; with 100 being the best possible outcome, and 0 being the worst.
Simple Shoulder Test (SST)
Time Frame: baseline, post-op months 3, 6, 12, and 24
The Simple Shoulder Test (SST): a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder; 2 questions relate to pain, 7 questions relate to function and 3 questions relate to range of motion. The answers to these questions (yes = 1, no = 0) provides a standardized way of recording the function of a shoulder before and after treatment (McClure \& Michener, 2003). A score of 12 on the Simple Shoulder test represents the best possible outcome, while a score of 0 represents the worst possible outcome.
Secondary Outcomes
- Rotator Cuff Re-tear Evaluation(Post-op months 6 and 12)
- Isometric Strength(baseline, post-op months 6, 12, and 24)