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Completed

NCT Number: NCT02200939

Post-Market Evaluation of the Rotation Medical Rotator Cuff System

The purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.

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Key information

Conditions

Partial Thickness Supraspinatus Tendon Tear Full Thickness Supraspinatus Tendon Tear

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southern California Orthopedic Institute, Van Nuys, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects enrolled in the study MUST meet all of the following criteria:

  • At least 21 years of age
  • Rotator cuff tear requiring surgery that meets either criterion A or B:

A. Medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant B. Medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair

  • Chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections
  • MRI of the shoulder within 60 days prior to the study procedure
  • Willing to comply with the prescribed post-operative rehabilitation program
  • Willing to be available for each protocol-required follow-up examination
  • Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
  • Ability to read, understand, and complete subject-reported outcomes in English

Exclusion criteria

Subjects enrolled in the study MUST NOT meet any of the following criteria:

  • Massive rotator cuff tears (≥ 5 cm)
  • Acute rotator cuff tears less than 12 months from injury
  • Previous rotator cuff surgery on the index shoulder
  • Instability of the index shoulder
  • Chondromalacia of index shoulder ≥ Grade 3
  • Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 2
  • Calcification of the index shoulder rotator cuff
  • Genetic collagen disease
  • History of insulin dependent diabetes
  • History of auto-immune or immunodeficiency disorders
  • History of chronic inflammatory disorders
  • Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
  • History of heavy smoking (> 1 pack per day) within last 6 months
  • Hypersensitivity to bovine-derived materials
  • Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
  • Currently involved in any injury litigation or worker's compensation claims relating to the index shoulder
  • Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
  • History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
  • History of cognitive or mental health status that interferes with study participation

Treatment and study plan

Bioinductive implant

Device

Other names: Rotation Medical Rotator Cuff System™, REGENETEN™ Bioinductive Implant System.

Surgical Repair

Device

Surgical repair with commercially-available sutures/suture anchors.

Primary outcomes

  1. Change in Tendon Thickness

    Time frame: Pre-operatively (baseline) to 3 month, 1 year, and 2 year

    The total thickness of the tendon and any newly induced tissue at the implant site were measured at 3 months, 1 year, and 2 years using magnetic resonance imaging (MRI). Measurements were compared to pre-operative (baseline) supraspinatus tendon thickness to calculate the mean (± SD) change in post-operative supraspinatus tendon thickness by partial-thickness tear size (Intermediate or High) or full thickness tear size (Medium or Large).

  2. Integration of Induced Tissue With Underlying Tendon

    Time frame: 3 months, 1 year, and 2 years

    Partial-thickness tears were classified as Intermediate (3-6 mm) or High (> 6 mm) grade tears. Full thickness tears were categorized using Cofield classification as Medium (1-3 cm) or Large (3-5 cm). Integration and maturation of the newly induced tissue was assessed by MRI at each post-operative follow-up and determined by answering Yes, No, or Unable to determine to the following questions:

    • Is there a visible boundary between the collagen scaffold/new tissue and the supraspinatus tendon?
    • Is there visible evidence of a good margin between the collagen scaffold/new tissue and the deltoid?
    • Was there evidence of bursitis in the shoulder?
    • Does the new tissue resemble normal tendon tissue?
    • Does the underlying tendon resemble normal tendon tissue?
    • Is there any new defect (i.e., loss in supraspinatus tendon continuity; re-tear)?

  3. Fill-In of Partial Thickness Tears and Underlying Tendon Quality

    Time frame: 3 months, 1 year, and 2 years

    For tendon defects treated by standalone use of the device (i.e., implantation without surgical repair using sutures/suture anchors), post-operative follow-up MRIs will be used to estimate the amount of defect fill-in with newly induced tissue and the quality of the filled-in tissue. In the absence of fill-in with newly induced tissue, defect progression (i.e., change in size relative to previous MRIs) will be assessed. The amount of fill-in relative to the pre-operative, baseline MRI classified as:

    • 0 to <25%
    • 25% to <50%
    • 50% to < 75%
    • 75% to < 100%
    • 100%

  4. Number of Participants With a Re-Tear

    Time frame: 3 months, 1 year, and 2 years

    Re-tear rate following rotator cuff repair assessed by MRI. Any new observable defect (i.e. loss in supraspinatus tendon continuity) will be classified as a re-tear.

Secondary outcomes

  1. Procedure Parameters: Device Implant Time

    Time frame: Intraoperative

    Mean (± SD) device implant time in minutes was assessed starting at time from introduction of the guide wire instrument into the subacromial space through completion of the last staple.

  2. Procedure Parameters: Procedure Technical Success

    Time frame: Intraoperative

    Procedure technical success was measured by the count of participants where the device was successfully delivered and affixed to the target tendon location (i.e., implant of device was attempted and successful).

  3. American Shoulder and Elbow Society (ASES) Score

    Time frame: Baseline, 3 month, 1 year, and 2 years

    The ASES consisted of subcomponent scores including pain, shoulder function, and shoulder scores as follows:

    • ASES Pain Score ranges from 0 to 10, with 0 being no pain and 10 being the worst pain (lower score better).
    • ASES Shoulder Function Score ranges from 0 to 30, with 0 being no function and 30 being full function (higher score better).
    • ASES Shoulder Score ranges from 10 to 100, with 0 being no function and 100 being normal function (higher score better).

    Scores were collected at baseline and each successive follow-up visits (3 months, 1 year, and 2 years).

  4. Constant-Murley Shoulder (CMS) Score

    Time frame: Baseline, 3 months, 1 year, and 2 years

    The overall CMS shoulder score ranges from 0 to 100, with 0 being severe restrictions and 100 being no restrictions (i.e., higher score is better). Scores were collected a baseline and each subsequent follow-up (3 months, 1 year, and 2 years).

  5. Recovery: Sling Time

    Time frame: Post-operatively to study completion, approximately 2 years

    Cumulative number of days index shoulder was in a sling.

  6. Recovery: Rehabilitation Time

    Time frame: Post-operatively to study completion, approximately 2 years

    Cumulative number of completed rehabilitation or physical therapy (PT) visits in days to treat index shoulder.

  7. Recovery: Return to Work

    Time frame: Post-operatively to study completion, approximately 2 years

    Cumulative number of days between discharge and return to work (employed subjects only).

  8. Recovery: Return to Normal Daily Activities

    Time frame: Post-operatively to study completion, approximately 2 years

    Return to normal daily activities (i.e. full, unrestricted activity) determined by the cumulative number of days between discharge and return to normal daily activity.

  9. Participant Satisfaction

    Time frame: 3 months, 1 year, and 2 years

    Self-reported measure of the level of satisfaction with the surgical outcome of the index surgery on 5-point Likert scale where participants were asked to indicated the best response to being satisfied with the outcome of the study procedure from one of the following:

    • Strongly Disagree
    • Disagree
    • Neither Agree or Disagree
    • Agree
    • Strongly Agree

    "Strongly Disagree" indicated the lowest level of satisfaction and "Strongly Agree" indicated the greatest level of satisfaction.

Sponsors and collaborators

Lead sponsor

Smith & Nephew, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jul 25, 2014
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.