Outcomes in Rotator Cuff Repair Using Graft Reinforcement

This study has been completed.
Sponsor:
Collaborator:
LifeCell
Information provided by (Responsible Party):
Tornier
ClinicalTrials.gov Identifier:
NCT01025037
First received: December 1, 2009
Last updated: January 21, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention
Rotator Cuff Tear
Device: Conexa Reconstructive Tissue Matrix

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tornier:

Primary Outcome Measures:
  • American Shoulder and Elbow Score (ASES) [ Time Frame: baseline, post-op months 3, 6, 12, and 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, post-op months 6, 12, and 24 ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, post-op months 3, 6, 12, and 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Post-op months 6 and 12 ] [ Designated as safety issue: No ]

    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.

    1. Primary definition (used for analysis of the secondary objective): Full thickness tear that is 80% or greater in length of the original tear size.
    2. Sub-analysis: Full thickness tear one centimeter or greater in length.

  • Isometric Strength [ Time Frame: baseline, post-op months 6, 12, and 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence of Complications, Including Infection [ Time Frame: All time points ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 61
Study Start Date: October 2009
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement at the rotator cuff repair site
Device: Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures
Other Name: Conexa, Conexa TM

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

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025037

Locations
United States, Arizona
Orthopaedic Clinical Association
Phoenix, Arizona, United States, 85016
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
OrthoNeuro
New Albany, Ohio, United States, 43054
United States, Pennsylvania
Rotheman Institute
Philadelphia, Pennsylvania, United States, 19107
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Tornier
LifeCell
Investigators
Study Director: Joseph Iannotti, MD Cleveland, OH
Study Director: John Sperling, MD Rochester, MN
  More Information

No publications provided

Responsible Party: Tornier
ClinicalTrials.gov Identifier: NCT01025037     History of Changes
Other Study ID Numbers: Tornier-LIFC LFC2008.03.02
Study First Received: December 1, 2009
Results First Received: January 13, 2015
Last Updated: January 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Tornier:
Rotator Cuff Tear, Large, Massive, Rotator, Cuff. Tear

ClinicalTrials.gov processed this record on May 26, 2015