Clinical Research Directory

ISB With SSNB & ANB

This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline). The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.

Lyophilized Platelet-Rich Plasma Lysate vs Dextrose Prolotherapy for Partial Rotator Cuff Tears

The goal of this clinical trial is to learn whether lyophilized platelet-rich plasma (PRP) lysate can improve shoulder symptoms, shoulder muscle strength, and tendon tear size in adults with partial-thickness rotator cuff tears, compared with hypertonic dextrose prolotherapy. The main questions this study aims to answer are: * Does PRP lysate improve shoulder pain and function in people with partial-thickness rotator cuff tears? * Does PRP lysate improve shoulder internal and external rotation strength? * Does PRP lysate reduce the size of the rotator cuff tendon tear as measured by ultrasound? Researchers will compare PRP lysate with hypertonic dextrose prolotherapy to determine whether the changes in shoulder symptoms, muscle strength, and tendon tear size differ between the two treatments. Participants will be randomly assigned to receive either PRP lysate or hypertonic dextrose. Each participant will receive one ultrasound-guided injection into the partially torn rotator cuff tendon each month for 3 months, for a total of three injections. Participants will complete a questionnaire about shoulder symptoms and function, undergo ultrasound examination of the rotator cuff, and have their shoulder rotation strength measured before the first injection and 1 month after the final injection. Participants assigned to the PRP lysate group will also have blood collected for preparation of the PRP lysate used for their treatment.

Percutaneous Tenotomy Versus Radiofrequency Ablation for Rotator Cuff Tear - Related Pain.

Rotator cuff tears are among the most common direct and indirect causes of chronic shoulder pain. Patients with irreparable rotator cuff tears face a choice of pain management options. The principal treatments available for chronic shoulder pain associated with irreparable rotator cuff tears include arthroscopic tenotomy of the long head of the biceps tendon, shoulder arthroplasty, pharmacological treatment, and radiofrequency ablation of the suprascapular nerve. Arthroscopic tenotomy of the long head of the biceps tendon is an established treatment for pain associated with massive irreparable rotator cuff tears, as supported by the available literature. Radiofrequency ablation of the suprascapular nerve provides temporary pain control by destroying the sensory nerve fibres supplying the shoulder joint. Tenotomy of the long head of the biceps tendon can be performed safely using a minimally invasive, ultrasound-guided outpatient procedure under local anaesthesia, without the general anaesthesia required for arthroscopy. The aim of the study is to compare the reduction in pain intensity and the duration of analgesia following percutaneous tenotomy of the long head of the biceps tendon versus continuous radiofrequency ablation of the suprascapular nerve. Changes in shoulder mobility limitations following the two procedures will also be compared using the Constant-Murley score, which assesses shoulder function.

Patient Education and Sling Use After Shoulder Surgery

This study will evaluate whether educational pamphlets can help patients safely manage personal hygiene, household activities, and female-specific self-care while wearing a sling after surgery. The study will also examine whether following sling-use instructions is associated with better short-term recovery and patient-reported outcomes for up to 6 months after surgery.

Ultrasound and Shear Wave Elastography for Assessment of the Quality of Rotator Cuff Muscles

Rotator cuff disorders are among the most frequent musculoskeletal causes of shoulder pain, weakness, and limited movement. In many individuals with rotator cuff disease, the damaged muscles gradually shrink (muscle atrophy) and become replaced by fat tissue (fatty infiltration), particularly involving the supraspinatus and infraspinatus muscles. These structural changes can impair shoulder function, reduce the likelihood of successful tendon repair surgery, and increase the risk of recurrent tears. Magnetic resonance imaging (MRI) is the established standard for assessing rotator cuff muscle health, but it is expensive, time-consuming, and not suitable for all individuals. Musculoskeletal ultrasound offers an accessible, real-time alternative, and shear wave elastography (SWE) adds the capability to quantitatively measure tissue stiffness. The purpose of this study is to evaluate the diagnostic accuracy and validity of combining conventional ultrasound with shear wave elastography to assess rotator cuff muscle quality, specifically fatty infiltration and muscle atrophy, in comparison with reference MRI or CT scans. Participants aged 18 years or older with suspected rotator cuff disorders who have had a qualifying shoulder MRI or CT scan within the previous 12 months will undergo an ultrasound and shear wave elastography examination of the affected shoulder. Researchers will calculate shear wave velocity and muscle occupation ratios to assess muscle stiffness and volume, and compare these results to validated MRI grading scales (the Goutallier classification for fat infiltration and the Warner staging system for muscle atrophy).

Remote App-based Rehabilitation After Rotator Cuff Repair

The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.

Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation

The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high rate of postoperative failure to heal. In such situations, there is a lack of connective tissue establishment between the rotator cuff tendon and the bone. One strategy to attempt to improve healing of the rotator cuff tendon back to the bone is via the use of extracellular matrix allograft. This treatment is composed of tissue from other humans, which is stripped of its cells so that just the scaffolding around the cells remains. This decellularized scaffolding can be placed at the rotator cuff healing site in an attempt to augment healing. Both animal studies and human studies have shown promise with this approach. Of those patients enrolling in the study, 50% will be assigned at random to receive a standard rotator cuff repair AND allograft treatment, while 50% will be assigned at random to receive standard rotator cuff repair WITHOUT allograft treatment. All patients enrolled in the study will also obtain an MRI at one year following surgery in order to assess tendon healing. Of note, one-year postoperative MRIs are not standard following rotator cuff repair - only those enrolled in the study will receive this MRI. There will be no financial consequence of receiving this MRI.

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 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.

Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery

This study is a randomized, double-blind, placebo-controlled pilot trial investigating the effects of BPC-157 on tendon healing and functional recovery following arthroscopic rotator cuff repair (aRCR). BPC-157 is a synthetic peptide that has demonstrated promising regenerative and anti-inflammatory effects in preclinical animal models of musculoskeletal injury, but it has not yet been studied in formal human clinical trials. Twenty patients undergoing aRCR will be enrolled and randomly assigned to receive either BPC-157 or a saline placebo. Participants will self-administer subcutaneous injections daily for 90 days following surgery. All other aspects of care will follow the standard postoperative rehabilitation protocol. The study will assess tendon healing using postoperative MRI, patient-reported outcome measures (PROMs), range of motion (ROM), and muscle strength via handheld dynamometry. Blood samples will also be collected to evaluate biomarkers associated with collagen turnover and inflammation. The goal of this pilot study is to evaluate the safety, feasibility, and preliminary efficacy of BPC-157 in promoting tendon healing and improving functional outcomes after rotator cuff repair. Results will inform the design of a future larger-scale clinical trial.

Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.

Rotator Cuff Tendon Repair With FiberLocker System Patch Augmentation

The overall objective of this clinical investigation is to assess the safety and efficacy of full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System for the subjects. The primary outcome of the investigation is to assess the safety after full-thickness arthroscopic rotator cuff repairs augmented with the FiberLocker System in terms of postoperative adverse events through the 12-month follow-up. Main secondary outcomes include measures of efficacy and clinical performance evaluated at 6-week, 4.5-month, and 12-month follow-ups including retear rate assessed using MRI and different functional performance scores.

Superior Capsular Reconstruction vs. Partial Repair for Massive Rotator Cuff Tears

Little evidence exists to guide treatment in patients with massive irreparable rotator cuff tears (MRCTS). Arthroscopic partial rotator cuff repair (PRCR) has the longest record of use. The new technique of superior capsular reconstruction (SCR) has more recently been described. Despite high enthusiasm for this technique, its effectiveness, cost and safety profile have not been established. The long-term goal of this study is to perform a multicenter randomized control trial to evaluate the effectiveness of SCR compared to PRCR in patients with MRCTS. The current study is a pilot required to support the development of an expanded formal clinical 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). 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.

The Contribution of Platelet-Rich Plasma to the Surgical Treatment of Rotator Cuff Tear: An Experimental Study

Purpose of the study: The aim of the study is to determine whether the postoperative administration of biological therapy with autologous platelet-rich plasma improves the clinical, imaging, and biochemical outcomes following surgical repair of a shoulder rotator cuff tear. What does the study involve? The study involves the postoperative administration of biological therapy after blood is drawn from the patients and processed appropriately. All patients will also undergo the necessary laboratory and imaging preoperative assessments, the surgical procedure, and standard postoperative rehabilitation, as routinely performed at this center. Tissue samples may be collected intraoperatively for testing. Postoperative follow-up will include clinical evaluations at specific time points-before surgery and at 1 month (regarding pain), 3 months, 6 months, and 1 year after therapy administration. At 6 months post-treatment, patients will undergo a follow-up MRI scan.

Preoperative Central Sensitization and Postoperative Outcomes After Arthroscopic Rotator Cuff Repair

This prospective observational study aims to investigate the effect of preoperative central sensitization on postoperative clinical outcomes in patients undergoing arthroscopic rotator cuff repair. Central sensitization, characterized by an increased responsiveness of the central nervous system to pain stimuli, has been associated with persistent pain and poor functional recovery in various musculoskeletal disorders. However, its impact on outcomes following arthroscopic rotator cuff repair has not been fully elucidated. Adult patients diagnosed with a rotator cuff tear by clinical examination and magnetic resonance imaging (MRI) and scheduled for arthroscopic repair will be enrolled. Preoperative central sensitization will be assessed using the Central Sensitization Inventory (CSI), while pain intensity and shoulder function will be evaluated using the Visual Analog Scale (VAS) and the Shoulder Pain and Disability Index (SPADI), respectively. Clinical assessments will be performed preoperatively and at postoperative 3 months. The study aims to determine whether preoperative central sensitization is associated with postoperative pain and functional recovery after arthroscopic rotator cuff repair.

Telerehabilitation vs. In-person Physiotherapy in Young Elite Baseball Players

This study compares physical therapy delivered through video calls to in-person therapy for young baseball players with shoulder pain. The goal is to see if remote therapy is as effective and easier for them to stick with

Interscalene Brachial Plexus Block and Early Wound-Related Symptoms After Open Rotator Cuff Repair

This exploratory randomized controlled trial evaluated the association of interscalene brachial plexus block (ISB) with early postoperative wound-related symptom scores and perioperative biomarker responses in patients undergoing open rotator cuff repair. Participants were randomly allocated to receive either ultrasound-guided interscalene brachial plexus block or standardized general anaesthesia. The primary outcome was postoperative wound-related assessment using the Toronto Symptom Assessment System for Wounds (TSAS-W) on postoperative days 5 and 14. TSAS-W was used as an exploratory patient-reported wound symptom assessment tool. Secondary outcomes included perioperative serum cytokine and growth-factor concentrations (IL-1β, IL-2, TNF-α, EGF, PDGF, and TGF-β), platelet counts, postoperative pain scores, tramadol consumption within 48 hours, time to mobilisation, and postoperative nausea and vomiting. This study aimed to investigate whether interscalene brachial plexus block was associated with differences in perioperative biological responses and postoperative wound-related symptom scores compared with general anaesthesia.

Oxandrolone Rotator Cuff Trial

This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.

Rotator Cuff Failure With Continuity

This proposal's objective is to challenge and expand the current definition of rotator cuff healing by investigating tendon retraction - broadly defined as medial translation of the repaired tendon away from the bone with or without a defect - as a common and clinically predictive structural outcome following rotator cuff repair. The investigators' central hypothesis is that failure with continuity is a common yet unrecognized structural phenomenon of rotator cuff healing that is significantly and meaningfully correlated with clinical outcomes. The investigators' approach is to characterize tendon retraction using an array of implanted radio-opaque markers, and investigate its relationship to pre-operative tissue quality (MRI), post-operative repair structural integrity (MRI) and clinical outcomes in a 125-patient prospective cohort study. These patients will complete (1) validated questionnaires and range of motion testing pre-operatively, (2) CT imaging at day of surgery, 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively, (3) MRI at 3 weeks, 3 and 6 months, and 1, 2 and 5 years post-operatively and (4) questionnaires, range of motion and strength testing at 3 and 6 months and 1, 2 and 5 years post-operatively.

RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS

This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery. Primary objective is the assessment in real life of the revision rate of the shoulder systems at long-term. Secondary objectives are * Revision rate at each post op visit * Range of motion at each post op visit * Quick Dash, Constant, American Shoulder and Elbow Surgeons Shoulder Score (ASES), Subjective Shoulder Value (SSV), Pain scores at each post op visit * Radiological assessment of implant positioning through geometrical parameters at each post op visit * Incidence of complications at each post op visit * Qualitative feedback from surgeons on the instrumentation

Phase 3 Study of the Efficacy and Safety of MR Arthrography Using the NEMO-103 Injection in Patients With Known or Suspected Shoulder Joint Diseases

The goal of this Phase 3 clinical trial is to evaluate whether MR arthrography enhanced with NEMO-103 injection (NEMO-103 Inj.) provides superior diagnostic imaging quality compared to unenhanced MRI in patients with known or suspected shoulder joint disorders, such as rotator cuff tendon tears, labral tears, and articular cartilage injuries. ⦁ The primary objective is to determine whether NEMO-103 Inj.-enhanced MR arthrography offers improved imaging quality in terms of joint distension, contrast resolution, and image sharpness compared to standard unenhanced MRI. Participation Details: * Each participant will undergo two MRI scans: one unenhanced and one enhanced with NEMO-103 Inj. * NEMO-103 Inj. will be administered once, during the second study visit. * Participants will attend a total of three site visits.

Reliability and Accuracy of a New Clinical Test for Biceps Lesions

The purpose of this study is to evaluate the accuracy and reliability of a new physical examination test (referred to as Said's test) for diagnosing injuries to the biceps tendon in the shoulder, specifically lesions of the long head of the biceps and SLAP tears. Diagnosing biceps injuries during a physical exam can be challenging, and existing standard tests can vary in their accuracy. This study aims to determine if this newly developed physical test is a more sensitive, specific, and reliable tool for doctors to use in a clinical setting. The study will enroll 144 adult participants (ages 18 to 70). These participants will be categorized into three groups: patients with isolated SLAP lesions, patients with complex shoulder injuries (such as a rotator cuff tear combined with a biceps lesion), and a control group of healthy individuals or asymptomatic shoulders. During the study, each participant will be examined by two independent doctors who are blinded to the patient's actual diagnosis. The doctors will perform the new physical test alongside traditional shoulder tests (the Speed's and O'Brien tests). To determine the true accuracy of these physical exams, the doctors' findings will be compared against definitive diagnostic methods, which will include an MRI, an MRA, or direct visualization during shoulder arthroscopy. By comparing the physical exam results to the gold standard imaging or surgical findings, researchers will calculate the new test's sensitivity, specificity, and inter-observer reliability.

Research and Clinical Validation of a Wearable Device-Based Remote Rehabilitation System for Postoperative Rotator Cuff Injury

This study included patients who underwent their first shoulder rotator cuff surgery at Peking University Third Hospital, diagnosed with small to medium rotator cuff tears based on MRI results. Participants were randomly divided into an online wearable device training group and an offline traditional rehabilitation group, with 36 individuals in each group. Before testing began, patients were ensured to participate voluntarily and had signed informed consent forms.

Atelocollagen ＆ Hyaluronic Acid Correlation With Enhancement of Rotator Cuff Healing: Synergistic Effect?

The purpose of this study is to analyze the correlation between the synergistic effects of atelocollagen and hyaluronic acid (HA) in enhancing rotator cuff healing postoperatively in patients undergoing rotator cuff repair surgery.The main questions it aims to answer are: * Does atelo Collagen aid in the rotator cuff repair healing process? * Does hyaluronic acid (HA) aid in the rotator cuff repair healing process? * Does the combined use of atelo collagen and HA in the rotator cuff repair healing process have a synergistic effect? The researchers will compare the use of atelo collagen and HA alone with no treatment to determine their effectiveness in rotator cuff healing. Participants will: * receive injections of atelo collagen or HA, either alone or in combination, during arthroscopic rotator cuff repair. * visit the clinic for medical checkups and tests every 3 months, 6 months, 1 year, and 2 years.