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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group with patch augmentation | Experimental | Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch |
|
| Comparison group without patch augmentation | Active Comparator | Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic rotator cuff reconstruction using fixation with anchors augmented with a synthetic polyester patch (Pitch-Patch Tissue Reinforcement Device)) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pain levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Hess, MD | Contact | +41 58 144 8143 | florian.hess@stgag.ch |
| Name | Affiliation | Role |
|---|---|---|
| Florian Hess, MD | Spital Thurgau AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spital Thurgau AG | Recruiting | Frauenfeld | Thurgau | 8501 | Switzerland |
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Single blind study in which only patients will not be aware of treatment (with or without rotator cuff augmentation with polyester patch)
|
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| Arthroscopic rotator cuff reconstruction using fixation with anchors augmented without a synthetic polyester patch | Device | Arthroscopic rotator cuff reconstruction using fixation with anchors and no augmentation with a synthetic polyester patch. |
|
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) |
| Healing rate | Using radiological imaging (ultrasound), healing of the rotator cuff tear will be monitored over time | 6-week and 1-year exams (postoperative) |
| 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) |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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