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 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 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 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 and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
Study Type
OBSERVATIONAL
Enrollment
37
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
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