Outcomes in Rotator Cuff Repair Using Graft Reinforcement

Rotator Cuff Tear Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025037
• Other study ID #: Tornier-LIFC LFC2008.03.02
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: January 21, 2015
• Start date: October 2009
• Est. completion date: April 2014

Study information

• Verified date: January 2015
• Source: Tornier, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Rotator Cuff Tear

Intervention

Device:
• Conexa Reconstructive Tissue Matrix
Conexa will be placed as a soft tissue reinforcement in primary open or mini-open rotator cuff repair procedures

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	OrthoNeuro	New Albany	Ohio
United States	Rotheman Institute	Philadelphia	Pennsylvania
United States	Orthopaedic Clinical Association	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Tornier, Inc.	LifeCell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Complications, Including Infection	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.	All time points	Yes
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	Post-op months 6 and 12	No
Secondary	Isometric Strength		baseline, post-op months 6, 12, and 24	No