Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pitch-Patch.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Tears of the Shoulder, Rotator Cuff Injuries. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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 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.
Interventions
- Device Pitch-Patch
Pitch-Patch device used for rotator cuff augmentation/ reinforcement.
Primary outcome measures
- Constant Murley Score (CMS) [Time frame: 2 years]
- Device Related or Procedure Related Adverse Events [Time frame: 2 years]
Secondary outcome measures (6)
- Re-tear Rate [Time frame: 2 years]
- Constant Murley Score (subscale) [Time frame: 2 years]
- Normal Daily Work/ Normal Recreational Activities [Time frame: 2 years]
- Tegner Score [Time frame: 2 years]
- Subjective Shoulder Value [Time frame: 2 years]
- Tissue Integration into the Pitch Patch [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Reading Shoulder Unit — Reading
Identifiers
NCT: NCT05906004 · CRE 031