An interventional study of Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) and Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch in Rotator Cuff Tears, sponsored by Spital Thurgau AG. Recruiting at 1 site in Switzerland. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-11.
Sponsored by Spital Thurgau AG · Not applicable, Interventional, and Treatment
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.
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.
734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 538 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Spital Thurgau AG is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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))
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
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.
Also known as: Pitch-Patch Tissue Reinforcement Device (version model number 102-1090)
Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch.
Rotator cuff retear rate
Occurence of retear following rotator cuff reconstruction to treat massive tear (measured using radiological imaging/ultrasound)
Time frame: Up to two years postoperative
Complication rate (adverse event greater than grade 2)
Development of postoperative complications following rotator cuff reconstruction to treat massive tear
Time frame: 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)
Time frame: 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
Time frame: 6-week and 1-year exams (postoperative)
Range of motion
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)
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Spital Thurgau AG