Outcomes in Rotator Cuff Repair Using Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement|
- American Shoulder and Elbow Score (ASES) [ Time Frame: baseline, post-op months 3, 6, 12, and 24 ] [ Designated as safety issue: No ]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.
- Adjusted Constant-Murley Score [ Time Frame: baseline, post-op months 6, 12, and 24 ] [ Designated as safety issue: No ]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).
- Simple Shoulder Test (SST) [ Time Frame: baseline, post-op months 3, 6, 12, and 24 ] [ Designated as safety issue: No ]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.
- Rotator Cuff Re-tear Evaluation [ Time Frame: Post-op months 6 and 12 ] [ Designated as safety issue: No ]
Subjects will have MRI to assess healing of the repaired tendon at 6 and 12 months post-op. The rate of re-tear will be reported.
Two different definitions of a re-tear were used for the analysis.
- Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.
- Sub-analysis: Full thickness tear one centimeter or greater in length.
- Isometric Strength [ Time Frame: baseline, post-op months 6, 12, and 24 ] [ Designated as safety issue: No ]
- Incidence of Complications, Including Infection [ Time Frame: All time points ] [ Designated as safety issue: Yes ]Complications were summarized by reporting adverse events of special interest. AEs of special interest were defined as any reported infection (incision, wound, surgical site), seroma, hematoma, inflammation (surgical site, wound), and re-tear. The re-tear rate reported in this section is the number reported via AE or surgical intervention (not the MRI results). The AEs of special interest were chosen because they are in alignment with the potential complications listed on the product insert.
|Study Start Date:||October 2009|
|Study Completion Date:||April 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site
Device: Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Other Name: Conexa, Conexa TM
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025037
|United States, Arizona|
|Orthopaedic Clinical Association|
|Phoenix, Arizona, United States, 85016|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|New Albany, Ohio, United States, 43054|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|United States, West Virginia|
|West Virginia University|
|Morgantown, West Virginia, United States, 26506|
|Study Director:||Joseph Iannotti, MD||Cleveland, OH|
|Study Director:||John Sperling, MD||Rochester, MN|