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.
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).
None
Rotator cuff tear treated with Pitch-Patch for augmentation or reinforcement of the rotator cuff.
Cohort
Other
Pitch-Patch
DevicePitch-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.
Device Related or Procedure Related Adverse Events
Device related and/ or procedure related adverse events up to at least 2 years after surgery
Re-tear Rate
Number of re-tear events as assessed by radiographical imaging (e.g., MRI, Ultrasound)
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.
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.
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.
