Treatment of Partial-Thickness Rotator Cuff Tears

Study Overview
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Brief Summary
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Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.

Detailed Description
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The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Official Title
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Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

Conditions
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Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness

Intervention / Treatment
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* Device: REGENETEN™ Bioinductive Implant
* Device: Arthroscopic repair of the high-grade (>50%) partialthickness


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients will be considered qualified for enrollment if they meet the following criteria: Male or female ≥18 years High-grade (>50% tendon thickness) partial-thickness tear Failed conservative medical management of the tendon tear defined as: Four (4) to six (6) weeks of formal physical therapy or guided home exercises Activity modification Shoulder injection at the discretion of the surgeon Able to comply with the post-operative physiotherapy and follow-up schedule Able to speak and read English Provide written informed consent Exclusion Criteria: Any one (1) of the following criteria will disqualify a patient from participation in the study: Prior shoulder surgery on index shoulder within 12 months of enrollment Failed primary rotator cuff surgery of the index shoulder On steroids within 1 month of enrollment Metastatic disease Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP) Concomitant biceps tenodesis Rheumatoid arthritis Advanced osteoarthritis Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 Chronic pain disorders (i.e., fibromyalgia) History of insulin dependent diabetes History of heavy smoking (> 1 pack per day) within 6 months of enrollment Currently involved in any injury litigation or workers compensation claims Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: REGENETEN™ Bioinductive Implant<br>Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. | Device: REGENETEN™ Bioinductive Implant<br>* The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.<br>|
| Other: Arthroscopic repair of the high-grade (>50%) partialthickness<br>Surgical treatment of partial-thickness rotator cuff tears using standard techniques. | Device: Arthroscopic repair of the high-grade (>50%) partialthickness<br>* Surgical treatment of partial-thickness rotator cuff tears using standard techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES (American Shoulder and Elbow Surgeons) score tear using standard surgical techniques. |  | at 3 months following index surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES score |  | over initial 3 months following index surgery | 
| Single Assessment Numeric Value (SANE) score |  | over initial 3 months following index surgery | 
| ASES Visual Analog Scale (VAS) pain score |  | over initial 3 months following index surgery | 
| ASES score |  | at 6, 12, 18 and 24 months following index surgery | 
| SANE score |  | at 6, 12, 18 and 24 months following index surgery | 
| ASES VAS pain score |  | at 6, 12, 18 and 24 months following index surgery | 
| Shoulder Stiffness Visual Analog Scale (VAS) score | Stiffness in the participant's index shoulder will be assessed using the shoulder stiffness VAS. The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: No Stiffness (0 mm) and Extreme Stiffness (100 mm). The VAS stiffness rating will be recorded pre-operatively, weekly from 1 week to 3 months post-surgery, and at 6 and 12 months post-surgery. | over 12 months following index surgery | 
| Cumulative opioid use to treat the index shoulder |  | over 12 months following index surgery | 
| Cumulative non-opioid prescription medication use to treat the index shoulder |  | over 12 months following index surgery | 
| Duration of shoulder immobilization |  | following index surgery | 
| Time to return to activities of daily living (ADLs) o Return to work by work type (sedentary; laborer) o Return to driving o Return to sports |  | following index surgery | 
| Incidence of progression to full-thickness tear |  | within 12 months following index surgery | 
| Incidence of progression to full-thickness tear |  | within 24 months following index surgery | 
| Incidence of revision surgery (index shoulder; all causes) |  | within 24 months following index surgery | 
| Aggregate health care utilization costs |  | over 12 months following index surgery | 
| Operating room time (index surgery) |  | Intra-operative | 
| Number of steroid injections |  | over 12 months following index surgery | 
| Number of unscheduled clinic visits |  | over 12 months following index surgery | 
| Number of for-cause imaging procedures |  | over 12 months following index surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REGENETEN, REGENETEN Bioinductive Implant, highgrade partial thickness tear, rotator cuff tear, rotator cuff repair