Patch Study (Patch-augmented Rotator Cuff Repair)

Last updated: October 4, 2023
Sponsor: Spital Thurgau AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT06076902
ProjectID 2023-00238
  • Ages 30-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 impairhealing
  • Unable or unwilling to restrict activities to prescribed levels or followrehabilitation 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

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device))
Phase:
Study Start date:
April 06, 2023
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • Spital Thurgau AG

    Frauenfeld, Thurgau 8501
    Switzerland

    Active - Recruiting

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