Rotator Cuff TearRotator Cuff TearsRotator Cuff Tears of the ShoulderRotator Cuff Injuries
Investigational drug(s) / intervention(s)
Pitch-Patch
Pitch-Patch: Pitch-Patch device used for rotator cuff augmentation/ reinforcement.
Study 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 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.
Eligibility
Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Constant Murley Score (CMS) — 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.
Device Related or Procedure Related Adverse Events — 2 years Device related and/ or procedure related adverse events up to at least 2 years after surgery
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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