Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch

Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch.

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 is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.

A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tear; Rotator Cuff Injuries; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder
• Intervention / Treatment: Device: Pitch-Patch

Detailed Description

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 is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years.

A minimum of 32 patients will be enrolled into the study. Follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

• Study Type: Observational
• Enrollment (Estimated): 32

Contacts and Locations

• Study Contact: Name: Vikki Adams; Phone Number: 01132387200; Email: vikki.adams@xiros.co.uk
• Study Contact Backup: Name: Steve Curran; Phone Number: 01132387200; Email: steve.curran@xiros.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Treated using Pitch-Patch device for augmentation or reinforcement of the rotator cuff since 2012.
• If applicable, patient is willing to participate in the study (beyond standard of (routine) care) and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Ethics Committee (EC).

Exclusion Criteria:

• There are no exclusion criteria; the aim of this study is to collect all data to see how the device is used in the real world setting.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-tear Rate	Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)	2 years
Constant Murley Score (subscale)	Change in CMS subscale scores (pain, activities of daily living, strength, and range of movement) from baseline and between post-surgery timepoints. CMS subscales: 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). The higher the score, the higher the shoulder function.	2 years
Normal Daily Work/ Normal Recreational Activities	Ability to perform normal daily work and normal recreational activities measured by CMS post-surgery. A subscale for Constant Murley Score, reported by the patient. Points range from 0-20, the higher the score, the higher the ability to perform normal daily work/ recreational activities.	2 years
Tegner Score	Change in Tegner Score from pre-injury and pre-surgery to post-surgery and between post-surgery timepoints. The Tegner activity is a scale to identify graded level of activity of a patient. The scale ranges from 0 (very low level of activity) to 10 (extremely active). A score greater than 6 is only achievable with participation in sport.	2 years
Subjective Shoulder Value	Change in Subjective Shoulder Value (SSV) score from baseline and between post-surgery timepoints. SSV is measured on a percentage scale from 0% to 100%, with a higher percentage reflecting a subjective feel of a normal shoulder.	2 years
Tissue Integration into the Pitch Patch	Tissue integration into the Pitch Patch will be assessed up to the 2 year time point and categorised into 'yes' or 'no' by the examiner. Tissue integration can be assessed from the following: Radiological data; Histological data; Photographic data	2 years

Collaborators and Investigators

• Sponsor: Xiros Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 7, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Rotator Cuff Repair; Rotator Cuff Reinforcement; Pitch-Patch; Xiros; Rotator Cuff Augmentation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CRE 031

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No