Clinical trial NCT01025037: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
Collaborators: name: LifeCell
First posted: 2009-12-03
Enrollment: 61
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

The patient:

1. is an adult male or female between the ages of 40-70 years old;
2. has repairable primary large retracted two-tendon rotator cuff tears measuring from 3 cm to 5 cm;
3. requires surgical repair of single rotator cuff (i.e. one limb);
4. 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;
5. is able to return for all scheduled and required study visits;
6. is able to provide written informed consent for study participation.

Exclusion Criteria:

The patient:

1. 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;
2. has a rotator cuff tear \< 3cm (measured intra-operatively);
3. has a rotator cuff tear \> 5cm (measured intra-operatively);
4. has a rotator cuff tear where the subscapularis tendon is disrupted/requires repair;
5. has grade 3 or 4 fatty infiltration of the rotator cuff;
6. has had prior surgical repair to the affected shoulder;
7. is American Society of Anesthesiologists (ASA) Class 4 or 5 (See Appendix I);
8. is a tobacco user; unless tobacco free 6 months prior to surgery and willing to remain tobacco free for the duration of the study.
9. has lower limb injuries requiring walking assist devices such as crutches and walkers;
10. 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.
11. has obstacles that pose an inordinately high surgical risk, in the judgment of the certified surgeon;
12. has co-morbid factors which predispose to postoperative infection, such as insulin dependent diabetes, chronic steroid use, malnourishment, cancer, or co-existent infection;
13. has a history of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or drug abuse or addiction;
14. 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;
15. has any of the conditions identified within the labeled contraindications, i.e. sensitivity to porcine derived products or polysorbate.
16. has an inability to have a closed MRI conducted.
17. needs a re-operation for a re-tear of the rotator cuff.

Primary outcomes:
measure: American Shoulder and Elbow Score (ASES)
timeFrame: baseline, post-op months 3, 6, 12, and 24
measure: Adjusted Constant-Murley Score
timeFrame: baseline, post-op months 6, 12, and 24
measure: Simple Shoulder Test (SST)
timeFrame: baseline, post-op months 3, 6, 12, and 24
Secondary outcomes:
measure: Rotator Cuff Re-tear Evaluation
timeFrame: Post-op months 6 and 12
measure: Isometric Strength
timeFrame: baseline, post-op months 6, 12, and 24
Other outcomes:
measure: Incidence of Complications, Including Infection
timeFrame: All time points
Locations:
city: Phoenix
country: United States
facility: Orthopaedic Clinical Association
state: Arizona
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: New Albany
country: United States
facility: OrthoNeuro
state: Ohio
city: Philadelphia
country: United States
facility: Rotheman Institute
state: Pennsylvania
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Cleveland, OH
name: Joseph Iannotti, MD
role: STUDY_DIRECTOR
affiliation: Rochester, MN
name: John Sperling, MD
role: STUDY_DIRECTOR
References: