Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the UK / NCT05906004
Recruiting Observational

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

NCT05906004 · tracked via the Priya Life Science UK tracker
Sponsor
Xiros Ltd
Phase
Observational
Started
2026-06-16
Last updated
2026-09-04

Condition(s) studied

Rotator Cuff TearRotator Cuff TearsRotator Cuff Tears of the ShoulderRotator Cuff Injuries

Investigational drug(s) / intervention(s)

Pitch-Patch

Pitch-Patch: Pitch-Patch device used for rotator cuff augmentation/ reinforcement.

Study summary

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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient has been treated using a Pitch-Patch device for augmentation or reinforcement of the rotator cuff 2-2.5years prior to enrolment. * 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 written informed consent as approved by the Ethics Committee (EC). Exclusion Criteria: \- The Pitch-Patch has been used outside its intended use.

Primary outcome measure(s)

  • Constant Murley Score (CMS) — 2 years
    The primary performance endpoint is the change in the CMS from baseline (if available) and between post-surgery timepoints up to at least 2 years after surgery. CMS comprises of 4 parts: Pain reported by the patient (max 15 points), activities of daily living reported by patient (max 20 points), range of movement assess by the examiner (max 40 points), and strength assessed by the examiner (max 25 points). Scores range from 0 to 100. Better functioning shoulders will have a greater number of points, up to a maximum of 100 points.
  • Device Related or Procedure Related Adverse Events — 2 years
    Device related and/ or procedure related adverse events up to at least 2 years after surgery

Trial sites (1)

FacilityCityRegionStatus
Reading Shoulder Unit Reading United Kingdom Recruiting

More Xiros Ltd trials in the UK

Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint Stabilisation Recruiting
Post-market Clinical Follow-up (PMCF) Study of the Poly-Tape Devices for Medial Patellofemoral Ligament (MPFL) Reconstruction Active, not recruiting

Other trials for the same condition

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears Recruiting
Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant Recruiting
Exactech Shoulder Post Market Clinical Follow-up Study Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05906004 on ClinicalTrials.gov ↗ ← All trials in the UK