Patch Study (Patch-augmented Rotator Cuff Repair)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorSpital Thurgau AG

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 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

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators