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Rotator Cuff Tears clinical trials

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NCT ID: NCT05450510 Recruiting - Rotator Cuff Tears Clinical Trials

Slow and Accelerated Rehabilitation Protocols

Start date: April 27, 2022
Phase: N/A
Study type: Interventional

Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.

NCT ID: NCT05439850 Recruiting - Rotator Cuff Tears Clinical Trials

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Start date: August 16, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

NCT ID: NCT05333211 Recruiting - Rotator Cuff Tears Clinical Trials

Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®

Start date: July 26, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.

NCT ID: NCT05329584 Recruiting - Rotator Cuff Tears Clinical Trials

InSpace Accelerated Rehabilitation Study

iAccelerate
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.

NCT ID: NCT05274737 Recruiting - Rotator Cuff Tears Clinical Trials

Comparison Of A Novel Sling With A Traditional Abduction Sling After Shoulder Surgery

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to determine if the novel shoulder sling has higher patient satisfaction compared to a traditional, abduction sling with at least equivalent postoperative outcomes after arthroscopic rotator cuff repair and total shoulder arthroplasty.

NCT ID: NCT05232773 Recruiting - Rotator Cuff Tears Clinical Trials

Rotator Cuff Surgery in Athletes: From Rehabilitation to Return to Sport

RCR-SPORT
Start date: January 31, 2022
Phase:
Study type: Observational

The main goal of this project is to study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport made by a set of objective shoulder evaluation indicators that are easy to use in clinical context. Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo four evaluation at different times. Healthy subjects will undergo evaluations with the same timing as patients.

NCT ID: NCT05214651 Recruiting - Rotator Cuff Tears Clinical Trials

A Clinical Research on Repair of Massive-large Rotator Cuff Tears

Start date: June 8, 2022
Phase: N/A
Study type: Interventional

The study is designed as a randomized controlled trial, a total of 52 participants with large - massive rotator cuff tears will be prospectively enrolled and randomly divided into 2 groups according to the applied repairing technique: novel double row technique group and suture bridge double row technique group. The functional outcome was measured at the preoperatively, 3, 6, 12 and 24 months postoperatively, using the visual analog scale (VAS) for pain, active and passive ROM, Constant score, American Shoulder and Elbow Surgeons (ASES) score, and University of California Los Angeles shoulder score (UCLA). The anatomic outcome was evaluated using magnetic resonance imaging at 3, 6, 12 and 24 months postoperatively. The clinical results were compared between the novel double row technique group and suture bridge double row technique group.

NCT ID: NCT05102968 Recruiting - Rotator Cuff Tears Clinical Trials

The Effect of Self-rehabilitation Using Communication APP After Arthroscopic Surgery for Rotator Cuff Tear

Start date: March 22, 2019
Phase: N/A
Study type: Interventional

The purpose of this study was to assess the clinical effect of a mobile application supporting home-based rehabilitation for the patients after arthroscopic rotator cuff repair. The investigators hypothesized the clinical results of the patients using a mobile application (APP) to support the home-based rehabilitation were comparable to the patients receiving the supervised rehabilitation. This prospective randomized case-control study was approved by the institutional review board of the Kaohsiung Veteran General Hospital (IRB No. KSVGH18-CT12-15) prior to enroll any patients. Patients were recruited if they had a small to medium-sized full-thickness rotator cuff tear or, a Lafosse type II or III subscapularis tear diagnosed and then repaired under shoulder arthroscope. After the surgery, patients were randomized either to the home-based rehabilitation (the home group) or the hospital supervised rehabilitation (the supervised group). In the home group, patients self-managed rehabilitation exercise without supervision. Rehabilitation were supportive with the APP. Patient could communicate with the physician via the APP. In the supervised group, patients attended one-on-one instructions with therapists and exercised under supervision at hospital. Patients' characters were recorded. Peri-operative factors associated with rotator cuff healing were assessed. The active ROM (forward elevation, abduction, external and internal rotation), the visual analogue scale (VAS) pain scores, the American shoulder and elbow surgeon shoulder (ASES) scores and the modified Constant scores were recorded pre-operatively and post-operatively 3, 6, 12 and 24 months. The isometric shoulder strength was assessed with the hand-held dynamometer. The compliance of post-operative rehabilitation was evaluated not only from patients' self-reported logs but also by physicians at post-operatively 6, 12 and 24 weeks. Tendon integrity was evaluated with MRI scan at least 6 months after the index surgery. In the pilot study, we found a mean difference of 4 points and a standard deviation of 5.5 points in the modified Constant scores. Power analysis revealed a total sample size of 62 patients (31 patients in each group) would achieve a statistical power of 0.8 with a two-tailed level of 0.05 to detect significant differences. Statistical level of significance was defined as p<0.05.

NCT ID: NCT05084781 Recruiting - Rotator Cuff Tears Clinical Trials

Arthroscopic Rotator Cuff Repair Utilizing Mechanical Bone Debridement Versus Coblation Debridement

FLOW90
Start date: July 8, 2020
Phase: N/A
Study type: Interventional

Randomized controlled trial comparing coblation debridement to mechanical debridement in rotator cuff repair.

NCT ID: NCT05026346 Recruiting - Rotator Cuff Tears Clinical Trials

Construction of an AI System for the Automatic Supervision of Shoulder's Rehabilitation Exercises (Rehab-SPIA)

Rehab-SPIA
Start date: April 1, 2020
Phase:
Study type: Observational

The current historical phase and the growing need for rehabilitation in the world make tele-rehabilitation systems, and e-Health in general, fundamental tools for increasing patient engagement and compliance with care, crucial elements for the preservation of the NHS from a perspective expenditure review and resource optimization. In particular, the rehabilitation patient has on average an adherence to the Home Exercise Program (HEP) between 30-50%, to which is frequently added a reduced effectiveness of motor learning due to the lack of feedback on the accuracy of the gesture, as is the case. it happens in the hospital or outpatient setting under the supervision of a therapist. The new computational approaches for the analysis of data on human movement, aimed at the development of algorithms to automatically supervise the accuracy of the patient's gesture during home self-treatment exercise such as those based on Artificial Intelligence (AI) and Machine Learning (ML), especially those of the latest generation, called sub-symbolics (or connectionists) can help. Among the most promising approaches are. Given the importance of the Home Exercise Program in shoulder disease, it was decided to select a population of patients affected by the main pathologies affecting this joint. The main objective of the study is to create and validate a software tool for the automatic and expert analysis of the correct execution of the main rehabilitation exercises for the functional recovery of the shoulder following orthopedic pathologies.