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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40506
Contact:
Cale Jacobs
859-797-8197
cale.jacobs@uky.edu

More Details

NCT ID
NCT03734536
Status
Recruiting
Sponsor
Smith & Nephew, Inc.

Study Contact

Karlie Morgan
512-496-7507
Karlie.morgan@smith-nephew.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.