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

NCT05906004 | Recruiting

• 1 other identifier: CRE 031
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Rotator Cuff Reinforcement; Rotator Cuff Repair; Pitch-Patch; Xiros; Rotator Cuff Augmentation

Outcome Measures

Primary Outcomes (2)

• Constant Murley Score (CMS)

  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.

  2 years

• Device Related or Procedure Related Adverse Events

  Device related and/ or procedure related adverse events up to at least 2 years after surgery

  2 years

Secondary Outcomes (6)

• Re-tear Rate

  2 years

• Constant Murley Score (subscale)

  2 years

• Normal Daily Work/ Normal Recreational Activities

  2 years

• Tegner Score

  2 years

• Subjective Shoulder Value

  2 years

Interventions

Pitch-Patch DEVICE

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.

You may qualify if:

• 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).

You may not qualify if:

• \- The Pitch-Patch has been used outside its intended use.

Sponsors & Collaborators

• Xiros Ltd: lead

Study Sites (1)

Reading Shoulder Unit

Reading, RG1 6UZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Central Study Contacts

Lisa Cook

CONTACT

+44 (0) 113 238 7200; lisa.cook@xiros.co.uk

Vikki Adams

CONTACT

07825626018; vikki.adams@xiros.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)