Patch Study (Patch-augmented Rotator Cuff Repair)

Not Applicable

Recruiting

• Conditions: Rotator Cuff Tears
• Interventions: Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch; Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))

• Registration Number: NCT06076902
• Lead Sponsor: Spital Thurgau AG

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.

Study Timeline

• Study Start: 2023-04-06
• Study First Submitted: 2023-09-18
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-11
• Last Update Posted: 2023-10-11
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison group without patch augmentation	Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch	Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch
Treatment group with patch augmentation	Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))	Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch

Primary Outcome Measures

Name	Time	Method
Rotator cuff retear rate	Up to two years postoperative	Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)

Secondary Outcome Measures

Name	Time	Method
Pain levels	Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)	During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)
Complication rate (adverse event greater than grade 2)	Up to two years postoperative	Development of postoperative complications following rotator cuff reconstruction to treat massive tear
Healing rate	6-week and 1-year exams (postoperative)	Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time
Range of motion	Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)	Clinical assessments of healing using the range of motion will be compared over time

Trial Locations

Locations (1)

Spital Thurgau AG; 🇨🇭 Frauenfeld, Thurgau, Switzerland