Treatment of Partial-Thickness Rotator Cuff Tears (REGEN PUB 2018)

Smith & Nephew

Status: Terminated

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

Treatments: Device: Arthroscopic repair of the high-grade (>50%) partial-thickness; Device: REGENETEN™ Bioinductive Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03734536

REGEN.PUB.2018.09

Details and patient eligibility

About

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.

Full description

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients will be considered qualified for enrollment if they meet the following criteria:

1. Male or female ≥18 years

2. High-grade (>50% tendon thickness) partial-thickness tear

3. Failed conservative medical management of the tendon tear defined as:

   1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
   2. Activity modification
   3. Shoulder injection at the discretion of the surgeon

4. Able to comply with the post-operative physiotherapy and follow-up schedule

5. 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:

1. Prior shoulder surgery on index shoulder within 12 months of enrollment
2. Failed primary rotator cuff surgery of the index shoulder
3. On steroids within 1 month of enrollment
4. Metastatic disease
5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
6. Concomitant biceps tenodesis
7. Rheumatoid arthritis
8. Advanced osteoarthritis
9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
10. Chronic pain disorders (i.e., fibromyalgia)
11. History of insulin dependent diabetes
12. History of heavy smoking (> 1 pack per day) within 6 months of enrollment
13. Currently involved in any injury litigation or workers compensation claims
14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

REGENETEN™ Bioinductive Implant

Other group

Description:

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.

Treatment:

Device: REGENETEN™ Bioinductive Implant

Arthroscopic repair of the high-grade (>50%) partial-thickness

Other group

Description:

Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Treatment:

Device: Arthroscopic repair of the high-grade (>50%) partial-thickness