Clinical trial NCT05906004: Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch
Official title: Retrospective Data Collection and Prospective Clinical Investigation for the Augmentation or Reinforcement of the Rotator Cuff Using the Pitch-Patch.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rotator Cuff Tear
Rotator Cuff Tears
Rotator Cuff Tears of the Shoulder
Rotator Cuff Injuries
Keywords: Rotator Cuff Reinforcement
Rotator Cuff Repair
Pitch-Patch
Xiros
Rotator Cuff Augmentation
Lead sponsor: Xiros Ltd
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.

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 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).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Constant Murley Score (CMS)
timeFrame: 2 years
measure: Device Related or Procedure Related Adverse Events
timeFrame: 2 years
Secondary outcomes:
measure: Re-tear Rate
timeFrame: 2 years
measure: Constant Murley Score (subscale)
timeFrame: 2 years
measure: Normal Daily Work/ Normal Recreational Activities
timeFrame: 2 years
measure: Tegner Score
timeFrame: 2 years
measure: Subjective Shoulder Value
timeFrame: 2 years
measure: Tissue Integration into the Pitch Patch
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
References: