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Regeneten Patch vs Standard Care in Partial Thickness Rotator Cuff Repair

NCT ID: NCT04673344

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Tears Shoulder Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Partial Rotator Cuff Repair

Routine partial rotator cuff repair

Group Type NO_INTERVENTION

No interventions assigned to this group

Partial Rotator Cuff Repair with Regeneten Scaffold

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

Group Type ACTIVE_COMPARATOR

Regeneten Collagen Patch

Intervention Type DEVICE

Partial rotator cuff repair surgery with the addition of the Regeneten scaffold

Interventions

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Regeneten Collagen Patch

Partial rotator cuff repair surgery with the addition of the Regeneten scaffold

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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FTJO2020-0876

Identifier Type: -

Identifier Source: org_study_id