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Patch Study (Patch-augmented Rotator Cuff Repair)

Primary Purpose

Rotator Cuff Tears

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
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 without a synthetic polyester patch
Sponsored by
Spital Thurgau AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Rotator Cuff Repair

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spital Thurgau AGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment group with patch augmentation

Comparison group without patch augmentation

Arm Description

Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch

Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch

Outcomes

Primary Outcome Measures

Rotator cuff retear rate
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)

Secondary Outcome Measures

Complication rate (adverse event greater than grade 2)
Development of postoperative complications following rotator cuff reconstruction to treat massive tear
Pain levels
During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)
Healing rate
Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time
Range of motion
Clinical assessments of healing using the range of motion will be compared over time

Full Information

First Posted
September 18, 2023
Last Updated
October 4, 2023
Sponsor
Spital Thurgau AG
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1. Study Identification

Unique Protocol Identification Number
NCT06076902
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
April 30, 2027 (Anticipated)
Study Completion Date
April 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spital Thurgau AG

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Rotator Cuff Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group with patch augmentation
Arm Type
Experimental
Arm Description
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch
Arm Title
Comparison group without patch augmentation
Arm Type
Active Comparator
Arm Description
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch
Intervention Type
Device
Intervention Name(s)
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))
Other Intervention Name(s)
Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch
Intervention Description
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.
Primary Outcome Measure Information:
Title
Rotator cuff retear rate
Description
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)
Time Frame
Up to two years postoperative
Secondary Outcome Measure Information:
Title
Complication rate (adverse event greater than grade 2)
Description
Development of postoperative complications following rotator cuff reconstruction to treat massive tear
Time Frame
Up to two years postoperative
Title
Pain levels
Description
During clinical assessments, patient reported pain levels will be measured using visual analogue scale (VAS); scale 0 (low) to 15 (high)
Time Frame
Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)
Title
Healing rate
Description
Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time
Time Frame
6-week and 1-year exams (postoperative)
Title
Range of motion
Description
Clinical assessments of healing using the range of motion will be compared over time
Time Frame
Preoperative and postoperative (6 weeks, 3 months, 1- and 2-year follow-up visits)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florian Hess, MD
Phone
+41 58 144 8143
Email
florian.hess@stgag.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Hess, MD
Organizational Affiliation
Spital Thurgau AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spital Thurgau AG
City
Frauenfeld
State/Province
Thurgau
ZIP/Postal Code
8501
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian Hess, MD
Phone
+41 58 144 8143
Email
florian.hess@stgag.ch

12. IPD Sharing Statement

Learn more about this trial

Patch Study (Patch-augmented Rotator Cuff Repair)

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