Evaluating the Use of a Bioinductive Graft in Treating Massive Rotator Cuff Tears

NCT04248751 | Unknown

• 1 other identifier: Regen
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The rotator cuff is a complex of 4 tendons that aid in stabilizing and moving the shoulder. Rotator cuff tears are common shoulder injuries in adults. While some tears can be managed by physiotherapy, other rotator cuff tears will require surgery. On occasion, when a person has had a large rotator cuff tear for a long period of time, the tear can grow and the tendons retract. This effect makes it very difficult for the tendons to be repaired to their normal spot. The most common surgical technique employed to manage a tear that cannot be repaired is to remove all unhealthy, inflamed scar tissue in a process called debridement. Often there is a bone spur that must be shaved down as well. This can help to reduce the pain in the patient as well as assist the range of motion slightly but will not prevent the tear becoming larger. This will also not prevent a re-tear of the tendons. Recently, surgeons have begun using a variety of materials to help reconstruct torn rotator cuffs. New grafts made of highly purified collagen from bovine tendons has been used to bridge large gaps in the tendons, and repair the tendon back to the bone. This technique has been done many times by skilled shoulder surgeons in Canada, the United States and around the world. Initial reports by surgeons who do this procedure show that the patients have less pain and better range of motion than before the surgery. Shoulder surgeons do not know which is the better treatment for large rotator cuff tears. Both treatments (graft and debridement) can reduce pain and improve movement of the shoulder. The purpose of this study is to help determine whether patients who receive an allograft have better function and fewer re-tear at one year after surgery than those who received a debridement alone.

Conditions

Rotator Cuff Tear; Rotator Cuff Injury

Outcome Measures

Primary Outcomes (1)

• Healing

  A change in healing to be assessed by comparing re-tear rates.

  2 years

Secondary Outcomes (7)

• VAS Pain

  Early recovery phase and 2 years

• Western Ontario Rotator Cuff Index

  1 and 2 years

• Marx Shoulder Activity Scale

  1 and 2 years

• Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire

  1 and 2 years

• American Shoulder and Elbow Surgeons (ASES) Questionnaire

  1 and 2 years

Study Arms (2)

Graft-Augmented

EXPERIMENTAL

Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin. Then, the graft will be delivered to the subacromial space and positioned over the bursal surface of the suprasinatus tendon, ensuring that the lateral edge of the implant will overlap with the head of the humerus. The graft will be fixed with tendon and bone staples.

Device: Regeneten

Non-augmented

ACTIVE COMPARATOR

Patients randomized to this group will receive a regular rotator cuff repair where the bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin.

Procedure: Debridement

Interventions

Regeneten DEVICE

A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears. This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness.

Graft-Augmented

Debridement PROCEDURE

The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin

Non-augmented

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Magnetic resonance imaging (MRI) proven diagnosis of a large \>3cm tear of the shoulder rotator cuff in a competent adult (\>18 years of age).

You may not qualify if:

• Patients with subscapular tear
• Glenohumeral osteoarthritis
• A normalized WORC score \>70 (where scores range between 0-100, and 100 is the best outcome)
• Uncontrolled diabetes (Hgb A1C \>7%)
• Pregnancy
• Presence of local or systemic infection
• Inability to cooperate with and/or comprehend post-operative instructions
• Nonvascular surgical sites (MRI proven)
• Poor nutritional state (Alb \<30 g/L)
• Cancer
• Paralysis of the shoulder
• Contracture of the shoulder
• Presence of cuff tear arthropathy or osteoarthritis of the shoulder
• Patients unable to provide informed consent for the study

Sponsors & Collaborators

• Ivan Wong: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2E1, Canada

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Debridement

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Ivan Wong, MD

  Orthopaedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Sparavalo, MASc

CONTACT

9024734251; sara@drivanwong.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD Orthopedic Surgeon

Model Details: Patients that have consented to the study will be randomized into 2 groups with a 50% chance of being in either group. Patients will be blinded and assessed by blinded assessors. Only after the one-year mark will the patient become unblinded following being asked which intervention they believe they received. Crossover design: Among those 38 patients without augmentation, we anticipate that 23 of them will have re-tear (assuming a 60% re-tear rate). We will offer them revision surgery with augmentation. Then those patients will be followed up 1 year and 2-years afterwards. MRI follow-up will be done at 1 year postoperatively to assess the healing rates. Outcome scores (as per above) will be collected at each follow-up and compared with their non-augmented scores to assess the improvement.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: January 30, 2020
• Study Start: January 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)