Outcomes in Rotator Cuff Repair Using Graft Reinforcement

NCT01025037 | Completed Results

• 1 other identifier: Tornier-LIFC LFC2008.03.02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to evaluate patient shoulder functional outcomes following rotator cuff repairs reinforced with a surgical mesh.

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear

Outcome Measures

Primary Outcomes (3)

• 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.

  baseline, post-op months 3, 6, 12, and 24

• 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).

  baseline, post-op months 6, 12, and 24

• 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.

  baseline, post-op months 3, 6, 12, and 24

Secondary Outcomes (2)

• Rotator Cuff Re-tear Evaluation

  Post-op months 6 and 12

• Isometric Strength

  baseline, post-op months 6, 12, and 24

Other Outcomes (1)

• Incidence of Complications, Including Infection

  All time points

Study Arms (1)

Conexa Reconstructive Tissue Matrix

OTHER

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

Device: Conexa Reconstructive Tissue Matrix

Interventions

Conexa Reconstructive Tissue Matrix DEVICE

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

Also known as: Conexa, Conexa TM

Conexa Reconstructive Tissue Matrix

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead
• LifeCell: collaborator

Study Sites (6)

Orthopaedic Clinical Association

Phoenix, Arizona, 85016, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

OrthoNeuro

New Albany, Ohio, 43054, United States

Location

Rotheman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Manager of Clinical Operations
• Organization: Tornier, Inc.

serickson@tornier.com

952-426-7674

Study Officials

• Joseph Iannotti, MD

  Cleveland, OH

  STUDY DIRECTOR

• John Sperling, MD

  Rochester, MN

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 3, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

US (6)