Clinical trial NCT04673344: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tears
Shoulder Surgery
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rotator Cuff Healing
timeFrame: 24 months
measure: Participant Satisfaction: ASES assessment
timeFrame: 24 months
measure: Participant Satisfaction: WORC assessment
timeFrame: 24 months
measure: Participant Satisfaction: SANE assessment
timeFrame: 24 months
measure: Participant Satisfaction: VR-12 assessment
timeFrame: 24 months
measure: Participant Satisfaction: GRC assessment
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References: