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Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tears, Shoulder Surgery

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regeneten Collagen Patch
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Partial Rotator Cuff Repair

Partial Rotator Cuff Repair with Regeneten Scaffold

Arm Description

Routine partial rotator cuff repair

Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch

Outcomes

Primary Outcome Measures

Rotator Cuff Healing
The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)
Participant Satisfaction: ASES assessment
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
Participant Satisfaction: WORC assessment
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
Participant Satisfaction: SANE assessment
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
Participant Satisfaction: VR-12 assessment
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
Participant Satisfaction: GRC assessment
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

Secondary Outcome Measures

Full Information

First Posted
December 4, 2020
Last Updated
December 14, 2020
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04673344
Brief Title
Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair
Official Title
Collagen Scaffold Augmentation of High Grade Partial Rotator Cuff Tendon Tears Improves Early Functional Recovery: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears, Shoulder Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial Rotator Cuff Repair
Arm Type
No Intervention
Arm Description
Routine partial rotator cuff repair
Arm Title
Partial Rotator Cuff Repair with Regeneten Scaffold
Arm Type
Active Comparator
Arm Description
Routine partial rotator cuff repair with the addition of the Regeneten scaffolding patch
Intervention Type
Device
Intervention Name(s)
Regeneten Collagen Patch
Intervention Description
Partial rotator cuff repair surgery with the addition of the Regeneten scaffold
Primary Outcome Measure Information:
Title
Rotator Cuff Healing
Description
The status of rotator cuff healing as demonstrated on post-operative MRI (at 6, 12 and 24 months)
Time Frame
24 months
Title
Participant Satisfaction: ASES assessment
Description
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
Time Frame
24 months
Title
Participant Satisfaction: WORC assessment
Description
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
Time Frame
24 months
Title
Participant Satisfaction: SANE assessment
Description
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
Time Frame
24 months
Title
Participant Satisfaction: VR-12 assessment
Description
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
Time Frame
24 months
Title
Participant Satisfaction: GRC assessment
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

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