Back to resultsOutcomes in Rotator Cuff Repair Using Graft Reinforcement
Primary Purpose
Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conexa Reconstructive Tissue Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
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;
- 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.
Sites / Locations
- Orthopaedic Clinical Association
- Rush University Medical Center
- Duke University Medical Center
- OrthoNeuro
- Rotheman Institute
- West Virginia University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Conexa Reconstructive Tissue Matrix
Arm Description
Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site
Outcomes
Primary Outcome Measures
American Shoulder and Elbow Score (ASES)
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
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)
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 Outcome Measures
Rotator Cuff Re-tear Evaluation
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
Full Information
NCT ID
NCT01025037
First Posted
December 1, 2009
Last Updated
January 21, 2015
Sponsor
Stryker Trauma GmbH
Collaborators
LifeCell
1. Study Identification
Unique Protocol Identification Number
NCT01025037
Brief Title
Outcomes in Rotator Cuff Repair Using Graft Reinforcement
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Trauma GmbH
Collaborators
LifeCell
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conexa Reconstructive Tissue Matrix
Arm Type
Other
Arm Description
Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site
Intervention Type
Device
Intervention Name(s)
Conexa Reconstructive Tissue Matrix
Other Intervention Name(s)
Conexa, Conexa TM
Intervention Description
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Primary Outcome Measure Information:
Title
American Shoulder and Elbow Score (ASES)
Description
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.
Time Frame
baseline, post-op months 3, 6, 12, and 24
Title
Adjusted Constant-Murley Score
Description
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).
Time Frame
baseline, post-op months 6, 12, and 24
Title
Simple Shoulder Test (SST)
Description
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.
Time Frame
baseline, post-op months 3, 6, 12, and 24
Secondary Outcome Measure Information:
Title
Rotator Cuff Re-tear Evaluation
Description
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.
Time Frame
Post-op months 6 and 12
Title
Isometric Strength
Time Frame
baseline, post-op months 6, 12, and 24
Other Pre-specified Outcome Measures:
Title
Incidence of Complications, Including Infection
Description
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.
Time Frame
All time points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Iannotti, MD
Organizational Affiliation
Cleveland, OH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Sperling, MD
Organizational Affiliation
Rochester, MN
Official's Role
Study Director
Facility Information:
Facility Name
Orthopaedic Clinical Association
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
OrthoNeuro
City
New Albany
State/Province
Ohio
ZIP/Postal Code
43054
Country
United States
Facility Name
Rotheman Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
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Outcomes in Rotator Cuff Repair Using Graft Reinforcement
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