Patch Study (Patch-augmented Rotator Cuff Repair)

Patch Study: a Single-center, Prospective, Single-blind, Randomized, Two-arm Controlled Study of Outcomes Following Synthetic Polyester Patch-augmented Rotator Cuff Repair

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florian Hess, MD; Phone Number: +41 58 144 8143; Email: florian.hess@stgag.ch

Study Locations

• Switzerland
  • Thurgau
    • Frauenfeld, Thurgau, Switzerland, 8501
      • Recruiting
      • Spital Thurgau AG
      • Contact: Florian Hess, MD; Phone Number: +41 58 144 8143; Email: florian.hess@stgag.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group with patch augmentation; Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch	Device: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)); The Pitch-Patch is a single-use device intended to reinforce the rotator cuff following or during repair by sutures or suture anchors where weakness exists in the soft tissue.; Other Names: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)
Active Comparator: Comparison group without patch augmentation; Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch	Device: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spital Thurgau AG
• Investigators: Principal Investigator: Florian Hess, MD, Spital Thurgau AG

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: September 18, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rotator Cuff Repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: ProjectID 2023-00238

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No