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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906004
• Other study ID #: CRE 031
• Status: Not yet recruiting
• Start date: January 2024
• Est. completion date: February 2028

Study information

• Verified date: August 2023
• Source: Xiros Ltd
• Contact: Vikki Adams
• Phone: 01132387200
• Email: vikki.adams[@]xiros.co.uk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: February 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiros Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Re-tear Rate	Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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