retrospective data collection and prospective clinical investigation for the augmentation or reinforcement of the rotator cuff using the pitch-patch

Conditions: Rotator Cuff Tear; Rotator Cuff Tears; Rotator Cuff Tears of the Shoulder; Rotator Cuff Injuries

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 is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years. a minimum of 32 patients will be enrolled into the study. follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective 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 is expected to be 4 years; this includes a recruitment period of 2 years, and a follow-up period (for the prospective clinical investigation) of 2 years. a minimum of 32 patients will be enrolled into the study. follow-up data will be collected at (if available for retrospective data) 3 months, 6 months, 1 year, 2 years and final follow-up (maximum 2.5 years for prospective study; maximum of 5 years for retrospective study).

Eligibility criteria:
inclusion criteria: * treated using pitch-patch device for augmentation or reinforcement of the rotator cuff since 2012. * if applicable, patient is willing to participate in the study (beyond standard of (routine) care) and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the ethics committee (ec). exclusion criteria: * there are no exclusion criteria; the aim of this study is to collect all data to see how the device is used in the real world setting.

Keywords: rotator cuff reinforcement rotator cuff repair pitch-patch xiros rotator cuff augmentation