At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pitch-Patch (device)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- Pitch-Patch — device: Pitch-Patch device used for rotator cuff augmentation/ reinforcement.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 16 Years and over
- Who
- All
- Number of participants
- 37
- Started
- 2026-06-16
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for rotator cuff tear
- • Clinical study - 37 participants
- • This is a clinical investigation study
Who can take part?
- • Ages 16 Years and over
- • Diagnosed with rotator cuff tear
Where?
- • Reading - Reading Shoulder Unit
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the study is expected to be 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline, procedure, and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
More detail
This is a clinical investigation study with both a prospective and retrospective study design. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the study is expected to be 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline, procedure, and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 16 Years and over
- Who can join: All genders
What the study is looking for
- ✓Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years...
- ✓Patient has a baseline Constant Murley Score (CMS), assessed within 30 days prior to implantation of the device.
- ✓Patient must be 16 years old or above.
- ✓Patient is willing to participate in the study, and having been informed of the nature of the study, has provided...
Who cannot take part
- ✗\- The Pitch-Patch has been used outside its intended use.
See the full criteria
Where Is This Study? (1 UK site)
Reading Shoulder Unit
Reading RG1 6UZ, United Kingdom
How to Get in Touch
Lisa Cook
Sponsor contactCONTACT
Vikki Adams
Sponsor contactCONTACT