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

Xiros

Status: Not yet enrolling

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

Treatments: Device: Pitch-Patch

Study type: Observational

Funder types: Industry

Identifiers

NCT05906004

CRE 031

Details and patient eligibility

About

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 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 and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.

Full 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 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 and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.

Enrollment: 37 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.