An observational study in Rotator Cuff Tear, Rotator Cuff Tears and Rotator Cuff Tears of the Shoulder, sponsored by Xiros Ltd. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Xiros Ltd · Observational
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.
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.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's planned enrollment of 37 is below the median of 70 across 145 observational studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Xiros Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- The Pitch-Patch has been used outside its intended use.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pitch-Patch device used for rotator cuff augmentation/ reinforcement.
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.
Time frame: 2 years
Device Related or Procedure Related Adverse Events
Device related and/ or procedure related adverse events up to at least 2 years after surgery
Time frame: 2 years
Re-tear Rate
Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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.
Time frame: 2 years
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
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Nov 2029, 41 months after the start.
Of 72 observational studies under Rotator Cuff Injuries, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 165. This study's planned 41 months is below that.
How these figures are worked out, and which studies are left out of them.
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