Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04248751 |
| Other study ID # |
Regen |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Nova Scotia Health Authority |
| Contact |
Sara Sparavalo, MASc |
| Phone |
9024734251 |
| Email |
sara[@]drivanwong.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Rotator cuff injuries are among the most common soft tissue injuries of the shoulder.
Characterized by insidious onset of progressive pain and weakness, with concomitant loss of
range of motion, patients with pathological conditions of the rotator cuff are often unable
to associate the onset of symptoms with a specific traumatic event. Loss of continuity of the
rotator cuff can be described in several ways, including acute or chronic, partial or
full-thickness and traumatic or degenerative. For this study, only patients with radiography
confirmed large rotator cuff tears (> 3 cm) resulting from trauma and/or degeneration will be
observed.
Historically, many operative procedures have been used by surgeons in the treatment of large
rotator cuff tears including open rotator cuff repair, mini- open rotator cuff repair,
arthroscopic rotator cuff repair, bridging techniques, debridement, arthroscopic rotator cuff
repair with acromioplasty, arthroscopic rotator cuff repair without acromioplasty, surgical
augmentation, debridement etc. While the surgical repair of large rotator cuff tears has
resulted in pain relief and improved function, the re-tear rate (55%-94%) has remained high
despite advances in repair techniques. The re-tear rates correlate with the size of the
rotator cuff tear as well as with other factors such as muscle atrophy, tendon quality, and
postoperative rehabilitation protocol.
With an effort to improve healing rates, surgeons have used various biologic tissues to
either substitute for or augment the repair of the rotator cuff. These tissues include the
patients' biceps tendon, fascia latae allografts and autografts, freeze-dried rotator cuff
allografts, and synthetic materials such as polypropylene mesh.1 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.
The investigators hypothesize that arthroscopic augmentation using a bioinductive collagen
implant will have superior outcomes in terms of increasing healing, thereby decreasing
re-tear rate, as compared to participants who are treated with the current gold standard
treatment (consisting of debridement, acromioplasty, and rotator cuff repair). The
investigators hypothesize that the participants with graft augment will have decreased pain
both during the early recovery phase and two years post-operatively as compared to the
non-augmented group. Additionally, the investigators hypothesize that participants with the
collagen scaffold will have better outcome scores at two years, as compared to the
non-augmented group.
