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NCT Number: NCT05906004

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

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rotator Cuff Tears Rotator Cuff Tears of the Shoulder Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Reading Shoulder Unit

Reading, RG1 6UZ, United Kingdom

Location status: Recruiting

Location contact

Ofer Levy

CONTACT

Ofer Levy

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pitch-Patch

Device

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

Primary outcomes

  1. Constant Murley Score (CMS)

    Time frame: 2 years

    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. Device Related or Procedure Related Adverse Events

    Time frame: 2 years

    Device related and/ or procedure related adverse events up to at least 2 years after surgery

Secondary outcomes

  1. Re-tear Rate

    Time frame: 2 years

    Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)

  2. Constant Murley Score (subscale)

    Time frame: 2 years

    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.

  3. Normal Daily Work/ Normal Recreational Activities

    Time frame: 2 years

    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.

  4. Tegner Score

    Time frame: 2 years

    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.

  5. Subjective Shoulder Value

    Time frame: 2 years

    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.

  6. Tissue Integration into the Pitch Patch

    Time frame: 2 years

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Cook

CONTACT

[email protected]

+44 (0) 113 238 7200

Vikki Adams

CONTACT

[email protected]

07825626018

Sponsors and collaborators

Lead sponsor

Xiros Ltd

Industry

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 15, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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