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Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

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ClinicalTrials.gov Identifier: NCT04673344
Recruitment Status : Enrolling by invitation
First Posted : December 17, 2020
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:

Shoulder pain is a common complaint with the most common reason being tendinopathy and/or tearing of the rotator cuff. While many rotator cuff tears are often considered normal, age-related degenerative disorders, with either partial- or full-thickness rotator cuff tears evident in 4% of patients aged <40 years and in 54% of patients aged >60 years, once they become symptomatic and conservative management fails, they are typically repaired surgically. Data suggest that the incidence of surgery to repair and re-attach the cuff continues to rise. However, despite positive clinical results overall, reports of repair failure after surgery can range from 16%-94%, and of those that do fail, or fail to heal, generally do so within the first 3 to 6 months post-surgery.

Given the aforementioned reported issues with the gold standard for the treatment of unresponsive and symptomatic partial or full rotator cuff tears (surgical repair), together with the invasiveness of this surgery and lengthy period of restricted activity, other means of treatment have been proposed.

The REGENETEN scaffold/implant seeks to support new tendon growth and disrupt disease progression. This study seeks to investigate the outcome of surgical rotator cuff repair versus scaffold augmentation (using the REGENETEN scaffold) for symptomatic partial thickness rotator cuff tears.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tears Shoulder Surgery Device: Regeneten Collagen Patch Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.
Estimated Study Start Date : December 30, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arm Intervention/treatment
No Intervention: Partial Rotator Cuff Repair
Routine partial rotator cuff repair
Active Comparator: Partial Rotator Cuff Repair with Regeneten Scaffold
Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch
Device: Regeneten Collagen Patch
Partial rotator cuff repair surgery with the addition of the Regeneten scaffold




Primary Outcome Measures :
  1. Rotator Cuff Healing [ Time Frame: 24 months ]
    The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)

  2. Participant Satisfaction: ASES assessment [ Time Frame: 24 months ]
    Participant Satisfaction with their surgical outcomes will be measured with the use of the American Shoulder and Elbow Surgeons at 6 week, 3-, 6-, 12- and 24 months after surgery

  3. Participant Satisfaction: WORC assessment [ Time Frame: 24 months ]
    Participant Satisfaction with their surgical outcomes will be measured with the use of the Western Ontario Rotator Cuff Index at 6 week, 3-, 6-, 12- and 24 months after surgery

  4. Participant Satisfaction: SANE assessment [ Time Frame: 24 months ]
    Participant Satisfaction with their surgical outcomes will be measured with the use of the Single Assessment Numeric Evaluation at 6 week, 3-, 6-, 12- and 24 months after surgery

  5. Participant Satisfaction: VR-12 assessment [ Time Frame: 24 months ]
    Participant Satisfaction with their surgical outcomes will be measured with the use of the Veteran's Rand 12 assessment at 6 week, 3-, 6-, 12- and 24 months after surgery

  6. Participant Satisfaction: GRC assessment [ Time Frame: 24 months ]
    Participant Satisfaction with their surgical outcomes will be measured with the use of the Global Rating of Change scale at 6 week, 3-, 6-, 12- and 24 months after surgery



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females aged 40-75 years with a partial-thickness rotator cuff tear (50% or more) confirmed on MRI scan that, in combination with patient-report symptoms and clinical examination by the orthopaedic surgeon, would confirm the rotator cuff tear as the primary pathology driving pain, symptoms and functional disability .
  • Symptoms > 3 months
  • Unsuccessful conservative treatment comprising of a corticosteroid injection (into the subacromial bursa) and physiotherapy (while it is acknowledged that a range of modalities may be available to patient's presenting with apparent symptomatic rotator cuff pathology, for the current study, physiotherapy has been defined specifically as a course of 'exercise-based' therapy specific to the individual patient, though generally comprising of exercises designed to strengthen the rotator cuff and scapula stabilizing musculature, improving flexibility and shoulder mobility)

Exclusion Criteria:

  • Revision surgery
  • Cervical pathology
  • Adhesive capsulitis
  • Multi-tendon tears
  • Concomitant upper limb pathology (eg: arthritis, nerve compression)
  • Infection
  • Previous fracture
  • Instability
  • Pregnancy and lactation
  • Professional athlete
  • Worker's compensation or compensable claim
  • Substance abuse or current mental illness
  • Smoker
  • Adverse reaction to bovine derived products

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673344


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04673344    
Other Study ID Numbers: FTJO2020-0876
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries