Rotator Cuff Tears of the Shoulder

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. Rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. Its incidence furthermore is expected to grow as the population ages. A wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full- thickness rotator cuff tears (RCTs). The latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the SINEFIX implant and instruments, are intended. Despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. RCTs may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however RCTs typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. Instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative RCTs. For RCTs, treatment options include both surgical and non-surgical (conservative) procedures. In this context, the SINEFIX implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction. A pilot study phase investigating the SINEFIX implant and instruments was conducted and showed adequate performance, usability and preliminary safety. Hence, the device is now being tested on a larger number of participants as part of the comparative study phase.

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.

The aim of this clinical trial is to investigate the effects of an attention shift-based rehabilitation program on clinical outcomes in individuals with rotator cuff-related shoulder pain (RCRSP). The study will evaluate the effects of an attention shift approach, in which motor tasks targeting regions outside the shoulder are performed concurrently with standard shoulder exercises, on pain, functional status, and pain catastrophizing. These results will be compared with those of a standard shoulder rehabilitation program. The main questions this study aims to answer are: Is there a difference in pain levels between individuals with RCRSP who participate in an attention shift-based rehabilitation program and those who participate in a standard exercise program? Is there a difference between these two rehabilitation approaches in terms of shoulder function and pain catastrophizing? Participants will: Be randomly assigned to either an attention shift-based rehabilitation group or a standard shoulder rehabilitation group Participate in supervised exercise sessions twice per week for 6 weeks Attend sessions lasting approximately 60-75 minutes Undergo clinical assessments at baseline and at week 6

The aim of this study is to evaluate the performance and safety of Move-Up's lok™ system (lok™ suture anchors range and associated instrumentation). These devices will be evaluated at approximately 3, 6 and 12 months with 3 scoring criteria: Constant score, VAS pain score, and subjective shoulder value score (SSV). At the 6-month and 12-month post-operative visit, tendon healing, and the absence of recurrence of rupture or failure to heal in patients treated with lok™ anchors will also be analyzed. The Sugaya score on ultrasound imaging will be used for this assessment. Adverse Events (AEs) and Serious Adverse Events (SAEs) will be assessed after the surgery and at each follow-up (1, 3, 6 and 12 months after the surgery).

The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument SN). The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. The secondary outcome measures are the Sugaya classification, Goutallier Stage and tendon quality based on MRI as well as objective scores and patient-reported outcome measures (PROMs) from validated outcome scoring systems.

Previous studies have shown that even when following standard sterilization protocols, the positive culture rate of Cutibacterium acnes can still be as high as 30%. In recent years, several studies have reported that preoperative skin preparation of the shoulder, such as applying benzoyl peroxide (BPO) to the skin, can effectively reduce the cutaneous bacterial load of C. acnes and even decrease its incidence in the shoulder joint or surgical sutures after surgery. However, most of the existing studies have focused on arthroplasty, and robust evidence regarding contamination in rotator cuff surgery remains lacking. Therefore, this study aims to investigate whether preoperative skin preparation with a 10% BPO acne cleanser can effectively reduce contamination in rotator cuff surgery. The findings will help guide future clinical practice in preoperative preparation. This study will adopt a prospective randomized design. Patients will be randomly assigned (using a random number table) into two groups: the control group and the BPO cleanser group. All patients will receive instructions on preoperative skin cleansing. Patients in the control group will follow the current routine practice in our institution, cleansing the surgical site (shoulder) with soap or body wash. Patients in the BPO group, in addition to routine preoperative instructions, will receive specific guidance on cleansing the shoulder and surrounding skin. They will be provided with a 10% BPO acne cleanser and instructed to use it on the shoulder and surrounding area during bathing the day before surgery. After surgical disinfection, skin samples will be collected for bacterial culture. In addition, a segment of surgical suture will be obtained postoperatively for bacterial culture.