Patch Study (Patch-augmented Rotator Cuff Repair)

Rotator Cuff Tears Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076902
• Other study ID #: ProjectID 2023-00238
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: April 30, 2027

Study information

• Verified date: October 2023
• Source: Spital Thurgau AG
• Contact: Florian Hess, MD
• Phone: +41 58 144 8143
• Email: florian.hess[@]stgag.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	Spital Thurgau AG	Frauenfeld	Thurgau

Sponsors (1)

Lead Sponsor	Collaborator
Spital Thurgau AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	Healing rate	Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time	6-week and 1-year exams (postoperative)
Secondary	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)