Clinical Research Directory

Lok™ Suture Anchors Safety & Performance Trial

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).

Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff

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.

Partial Rotator Cuff Injury Combined With Stiff Shoulder

A Randomized Controlled Trial Comparing Early Surgical Intervention Versus a Structured Rehabilitation Program with Delayed Surgery if Needed for Partial-Thickness Rotator Cuff Tears with Concomitant Shoulder Stiffness: The SPIRIT Trial (Surgery for Partial Tears with Immobility Randomized Intervention Trial)

FiberLocker® System Augmentation of Rotator Cuff Repairs

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.

Acne Face Wash for Reducing the Contamination Rate in Arthroscopic Rotator Cuff Repair Surgery

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.

Integrity Implant System Post Market Clinical Follow-Up Study

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).

SINEFIX-2022 Comparative Phase

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.

Evaluation of Medial Supraspinatus Muscle Release in Treatment of Retracted Rotator Cuff Tear

\- Introduction Rotator cuff tears are a prevalent cause of shoulder pain and dysfunction, particularly among individuals engaged in repetitive overhead activities or advancing in age. The supraspinatus muscle, integral to shoulder function, initiates abduction and provides essential stability to the glenohumeral joint. When the supraspinatus tendon tears and retracts, surgical intervention is often necessary to restore function and alleviate symptoms. (1) Traditional surgical approaches for retracted rotator cuff tears typically involve reattaching the tendon to the greater tuberosity of the humerus. However, severe retraction can lead to challenges during repair, including increased tension on the repair site, potentially compromising healing and increasing the risk of re-tears. • Partial Repair with or without Augmentation: In cases of moderate retraction where complete tendon mobilization is challenging, a partial repair combined with augmentation techniques (e.g., patch augmentation, autografts, allografts) may be considered to optimize tendon-to-bone healing. • Tendon Transfer: For massive irreparable tears or poor tendon quality, tendon transfer procedures (e.g., transferring the teres minor or lower trapezius tendon) may be necessary to restore function and shoulder stability. (2) To address these challenges, medial release of the supraspinatus tendon from its attachment on the medial border of the scapula has emerged as a promising technique. Medial release involves detaching the supraspinatus tendon from its scapular attachment and mobilizing it medially. This technique aims to reduce tension at the repair site, allowing for better tendon apposition and potentially improving healing outcomes. Proponents suggest that medial release enhances biomechanical strength and reduces the risk of postoperative complications such as re-tears. However, the technique's optimal application, outcomes, and comparative effectiveness against traditional repair methods remain subjects of ongoing research and debate within the orthopedic community. (3) Given the complexity and variability of retracted rotator cuff tears, a systematic evaluation of medial release is crucial to clarify its efficacy, safety, and role in surgical management. This protocol outlines a comprehensive framework for evaluating medial release of the supraspinatus tendon in the repair of retracted rotator cuff tears. The study aims to provide evidence-based insights that can guide surgical decision-making, improve patient outcomes, and advance the field of shoulder surgery. Furthermore, medial release may enhance the biomechanical integrity of the repair. By optimizing tendon positioning and tension during repair, it could improve the mechanical strength of the repair construct. This aspect is crucial for achieving durable outcomes and preventing repair failure over time..