- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025037
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
January 21, 2015 updated by: Stryker Trauma GmbH
A Prospective, Multi-Center, Single-Arm Study to Assess Clinical Outcomes In Primary Open or Mini-Open Rotator Cuff Repair Using Conexa Graft Reinforcement
The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85016
- Orthopaedic Clinical Association
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Illinois
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Ohio
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New Albany, Ohio, United States, 43054
- OrthoNeuro
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Rotheman Institute
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West Virginia
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Morgantown, West Virginia, United States, 26506
- West Virginia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site
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Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
American Shoulder and Elbow Score (ASES)
Time Frame: baseline, post-op months 3, 6, 12, and 24
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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.
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baseline, post-op months 3, 6, 12, and 24
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Adjusted Constant-Murley Score
Time Frame: baseline, post-op months 6, 12, and 24
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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).
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baseline, post-op months 6, 12, and 24
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Simple Shoulder Test (SST)
Time Frame: baseline, post-op months 3, 6, 12, and 24
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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.
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baseline, post-op months 3, 6, 12, and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rotator Cuff Re-tear Evaluation
Time Frame: Post-op months 6 and 12
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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.
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Post-op months 6 and 12
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Isometric Strength
Time Frame: baseline, post-op months 6, 12, and 24
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baseline, post-op months 6, 12, and 24
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Complications, Including Infection
Time Frame: All time points
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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.
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All time points
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Joseph Iannotti, MD, Cleveland, OH
- Study Director: John Sperling, MD, Rochester, MN
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
December 1, 2009
First Submitted That Met QC Criteria
December 1, 2009
First Posted (Estimate)
December 3, 2009
Study Record Updates
Last Update Posted (Estimate)
January 26, 2015
Last Update Submitted That Met QC Criteria
January 21, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tornier-LIFC LFC2008.03.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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