Outcomes in Rotator Cuff Repair Using Graft Reinforcement

NCT ID: NCT01025037

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-04-30

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.

Conditions

Rotator Cuff Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conexa Reconstructive Tissue Matrix

Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site

Group Type: OTHER

Conexa Reconstructive Tissue Matrix

Intervention Type: DEVICE

Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures

Interventions

Conexa Reconstructive Tissue Matrix

Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures

Intervention Type: DEVICE

Other Intervention Names

Conexa, Conexa TM

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeCell

INDUSTRY

Sponsor Role: collaborator

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Iannotti, MD

Role: STUDY_DIRECTOR

Cleveland, OH

John Sperling, MD

Role: STUDY_DIRECTOR

Rochester, MN

Locations

Orthopaedic Clinical Association

Phoenix, Arizona, United States

Rush University Medical Center

Chicago, Illinois, United States

Duke University Medical Center

Durham, North Carolina, United States

OrthoNeuro

New Albany, Ohio, United States

Rotheman Institute

Philadelphia, Pennsylvania, United States

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

Tornier-LIFC LFC2008.03.02

Identifier Type: -

Identifier Source: org_study_id