RecruitingOBSERVATIONAL

Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff

This study is investigating a medical device called the Pitch-Patch, which is used to help repair tears in theoulder's rotator cuff. The Pitch-Patch is already approved for use and is made of a strong, single-use material. Researchers want to understand how safe and effective it is over the long term when used as intended. They will be looking at information from patients who have already had the Pitch-Patch implanted 2 to 2.5 years ago. The study will collect existing medical records and involve a follow-up visit. This is a single-group study, meaning all participants received the Pitch-Patch. The study is expected to last three years and will include at least 37 patients.

At a glance

Status

Recruiting

Sponsor

Xiros Ltd

Enrolment target

Start

01 May 2026

Estimated completion

01 Dec 2029

Rotator Cuff Tear Rotator Cuff Tears Rotator Cuff Tears of the Shoulder Rotator Cuff Injuries

What is this study about?

This study is about a medical device called the Pitch-Patch, which is used during surgery to help fix tears in the shoulder's rotator cuff. The rotator cuff is a group of muscles and tendons that surround the shoulder joint, helping you lift and rotate your arm. When it gets torn, it can be very painful and limit movement.

The Pitch-Patch acts like a support or reinforcement for the shoulder repair. It's a special type of strong, single-use patch made by a company called Xiros Ltd, and it's already available for doctors to use. The main goal of this 'Post-Market Clinical Follow-up' study is to check on the long-term safety and how well the Pitch-Patch performs in real-world use, making sure it works as expected when implanted to help repair partially torn rotator cuffs.

Researchers will be collecting information from patients who have already had the Pitch-Patch implanted a couple of years ago. This helps them understand the long-term effects and ensures that the device continues to meet safety and performance standards. It's an important step in making sure medical devices are safe and effective for everyone who uses them.

Key takeaways

This study is monitoring the long-term safety and performance of the Pitch-Patch device.
The Pitch-Patch is an approved medical device for rotator cuff repair, not experimental.
Participation involves providing existing medical records and one follow-up visit.
You must have had your Pitch-Patch implanted 2 to 2.5 years ago to be eligible.
No new treatments or medications are given during the study.
Your involvement helps gather important data for future patient care.

Who may be eligible?

To be considered for this study, you must have had a Pitch-Patch device implanted in your shoulder between 2 and 2.5 years ago to help with a rotator cuff tear. You also need to have had a specific shoulder health assessment (called a Constant Murley Score) recorded within 30 days before your Pitch-Patch surgery.

You need to be at least 16 years old. Most importantly, you must be willing to take part and provide your written permission after a full explanation of the study has been given to you. Your involvement is completely voluntary.

You would not be able to participate if the Pitch-Patch was used for something other than its intended purpose, for example, if it wasn't used to specifically help augment or reinforce a rotator cuff repair.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Did you have a Pitch-Patch device implanted for a rotator cuff tear 2 to 2.5 years ago?
Was your shoulder assessed (with a Constant Murley Score) within 30 days before that surgery?
Are you 16 years old or older?
Are you willing to provide your written permission to participate after understanding the study?

Answer every question to see your result.

What does participation involve?

If you join this study, it simply means that information about your past Pitch-Patch surgery and recovery will be collected. You will have a specific follow-up visit to the study clinic between 2 and 2.5 years after your Pitch-Patch implant. During this visit, researchers will gather current information about your shoulder’s condition. In addition to this, they will look back at your existing medical records for information from before your surgery and at earlier points like 3 months, 6 months, and 1 year after your surgery, if these records are available. You won't receive any new medication as part of this study. The total study duration, observing all participants, is expected to be 3 years.

Potential risks and benefits

Taking part in this study primarily involves the collection of your existing medical information and a follow-up visit. A potential benefit could be contributing to important knowledge about the long-term safety and effectiveness of the Pitch-Patch, which may help future patients. As this study collects data from an already implanted device, there are no new risks directly associated with the device implant itself as part of participating. Any medical procedure carries inherent risks, but those would have been discussed with you at the time of your surgery. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Reading Shoulder Unit
Verified postcode
Reading, United Kingdom· Recruiting

Common questions

What is the Pitch-Patch?

The Pitch-Patch is a medical device, a special patch, used during surgery to strengthen or support repairs of tears in the shoulder's rotator cuff.

Is the Pitch-Patch new or experimental?

No, the Pitch-Patch is already approved for use and available on the market. This study is checking its long-term safety and how well it works after being used by patients.

What will I have to do if I join the study?

If you join, the study will mainly collect information from your existing medical records and from a follow-up visit, which will take place 2 to 2.5 years after your Pitch-Patch surgery.

Will I receive any new treatment?

No, this study is about collecting information on a device you've already had implanted. You will not receive any new medication or treatment as part of this study.

How long will the study last for me?

Your involvement focuses on providing information from your medical records and during one follow-up visit. The overall study to collect information from all patients is expected to last three years.

How to find out more

Lisa Cook

lisa.cook@xiros.co.uk +44 (0) 113 238 7200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.