Clinical trial NCT06076902: Patch Study (Patch-augmented Rotator Cuff Repair)
Official title: Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Rotator Cuff Repair
Lead sponsor: Spital Thurgau AG
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

Detailed description: This single-center, prospective, randomized controlled study will compare patients allocated to two treatment arms who are undergoing surgery to repair rotator cuff tears: (1) arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch, and (2) arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. The primary objective is to compare complications (primarily retear rates) and the secondary objective is to compare mid- and long-term clinical and radiological outcomes using standard orthopedic assessments, such as the subjective shoulder value and the Constant-Murley score.

The Pitch-Patch is a single-use synthetic polyester patch (Pitch-Patch, neoligamentsTM, Leeds, UK) intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue. The surgical group will be randomly assigned, and each group will include 150 patients. After surgery, patients will be followed for two years and undergo clinical and radiological assessments.

The main research question to be answered by this investigation is whether synthetic patch augmentation can significantly improve outcomes in patients with rotator cuff tears from either degenerative or traumatic origins versus patients with no patch augmentation.

Eligibility criteria: Inclusion Criteria:

* Adults with massive rotator cuff tear
* Tear must affect at least two tendons
* Primary surgery only
* Origin of tear can be either degenerative or traumatic
* German language speaking

Exclusion Criteria:

* Fatty infiltration grade 4 (according to Goutallier)
* Bilateral tears
* Cases of arthritis or severe osteoarthritis
* Structural or pathological condition of the bone or soft tissue that could impair healing
* Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines
* Unable or unwilling to give consent (language barrier or cognitive impairment)
* Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits

Primary outcomes:
measure: Rotator cuff retear rate
timeFrame: Up to two years postoperative
Secondary outcomes:
measure: Complication rate (adverse event greater than grade 2)
timeFrame: Up to two years postoperative
measure: Pain levels
timeFrame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
measure: Healing rate
timeFrame: 6-week and 1-year exams (postoperative)
measure: Range of motion
timeFrame: Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Other outcomes:
Locations:
city: Frauenfeld
country: Switzerland
facility: Spital Thurgau AG
state: Thurgau
Study officials:
affiliation: Spital Thurgau AG
name: Florian Hess, MD
role: PRINCIPAL_INVESTIGATOR
References: