Clinical Research Directory

Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?

Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT). Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.

Dermis on Demand Allograft Augmentation for Rotator Cuff Repair

The purpose of this study is to find out whether adding a human acellular dermal allograft (Dermis on Demand) during arthroscopic rotator cuff repair improves tendon-to-bone healing and lowers the rate of re-tear compared to standard repair alone. Sixty adults with large (3-5 cm) full-thickness superior or posterosuperior rotator cuff tears will be randomly assigned to repair with or without the allograft. Healing will be assessed by MRI at 12 months and by ultrasound at 6 months after surgery. Patient-reported outcomes, shoulder range of motion and strength, and operative time will also be compared between the groups.

Treatment of Rotator Cuff Tears With Platelet Rich Plasma

The purpose of this study is to evaluate the safety and effectiveness of dual platelet rich plasma (PRP) injections into the rotator cuff insertion and the area of the tendon proximal to the insertion.

Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears

Large-to-massive rotator cuff tears of the shoulder with poor tendon and muscle quality often cannot be fully repaired back to its footprint, and they have a high risk of re-tear. This study evaluates a combined technique for these tears. During surgery, the torn rotator cuff is repaired as far as possible, the long head of the biceps tendon is transposed (rerouted) and fixed to the top of the humeral head, and the repair is augmented with an acellular dermal matrix graft (MegaDerm Plus, L\&C Bio, Republic of Korea). All participants receive the same operation and the same structured rehabilitation program; there is no comparison group. Forty adults aged 40 to 75 years treated at Tam Anh General Hospital, Ho Chi Minh City, Vietnam, will be followed for 12 months after surgery. The main outcome is the rate of tendon retear on MRI at 12 months. Pain, shoulder function scores (Constant, ASES, UCLA), range of motion, muscle strength, X-ray findings and complications, including graft-related complications, will also be recorded.

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.

Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

Fibrin Clot Augmentation in Arthroscopic Rotator Cuff Repair

The aim of this study is to evaluate whether applying an autologous fibrin clot to the repair site improves tendon healing and clinical outcomes after arthroscopic rotator cuff repair. Fifty patients with rotator cuff tears requiring surgery were randomly assigned to two groups: arthroscopic repair with autologous fibrin clot augmentation or standard arthroscopic repair alone. The fibrin clot is prepared from the patient's own blood without centrifugation. Tendon healing is assessed with magnetic resonance imaging (MRI) using the Sugaya classification at 12 months, and shoulder function and pain are assessed with the ASES score, Constant score and Visual Analog Scale (VAS) preoperatively and at 3, 6 and 12 months.

Repeated Injections of Adipose-derived Stem Cells in Rotator Cuff Tears

The aim of the project is to investigate whether repeated implantations of micro-fragmented adipose tissue (MFAT), into the shoulder muscle can improve the outcome of standard surgical treatment for rotator cuff tears (RCT). The investigators hypothesize that combining surgery with repeated implantations of micro-fragmented adipose tissue (MFAT) into the muscle provides a more effective treatment for patients with rotator cuff tears compared to standard surgical treatment. The result would be better outcomes such as improved shoulder functioning and reduced pain.

Pain Education After Rotator Cuff Surgery

Study Title: The Effect of Pain Neuroscience Education Combined with Conventional Rehabilitation on Pain Management and Functional Outcomes in Patients Undergoing Mini-Open Rotator Cuff Repair Purpose: This study aims to investigate whether adding Pain Neuroscience Education (PNE) to a conventional rehabilitation program improves pain management, physical function, and psychosocial outcomes in patients who have undergone mini-open surgery for rotator cuff tears (RCT). The study will also compare the effects of PNE when delivered before versus after surgery. Who Can Participate: Adults aged 40-75 who have been diagnosed with a medium-sized rotator cuff tear and are scheduled for mini-open surgical repair. Participants must meet specific health criteria and be willing to participate in the rehabilitation program. Study Details: Participants will be randomly assigned to one of three groups: Group 1: Conventional rehabilitation only. Group 2: Conventional rehabilitation + PNE before surgery. Group 3: Conventional rehabilitation + PNE after surgery. PNE involves educational sessions that explain the biology of pain, how the nervous system processes pain, and strategies to reduce fear and catastrophizing related to pain. The study will last approximately 12 weeks, with regular assessments of pain levels, physical function, and psychosocial factors (e.g., fear of movement, depression, sleep quality). Potential Benefits: Participants may experience reduced pain, improved shoulder function, and better overall recovery. The study may provide valuable insights into how PNE can enhance rehabilitation outcomes for patients with rotator cuff tears. Potential Risks: Some participants may find the educational sessions time-consuming or mentally challenging. There is a small risk of discomfort during physical assessments or rehabilitation exercises. Why is this study important?: Rotator cuff tears are a common cause of shoulder pain and disability, especially in older adults. Post-surgical pain and fear of movement can slow recovery and reduce quality of life. This study will help determine whether PNE, when combined with conventional rehabilitation, can improve recovery outcomes and provide a better understanding of how timing (before or after surgery) affects its effectiveness.

Effect of Kinesio Taping After Rotator Cuff Surgery

This prospective randomized controlled trial evaluated whether adding Kinesio Taping (KT) to a standardized postoperative rehabilitation program improves early clinical recovery after arthroscopic rotator cuff repair. Patients undergoing arthroscopic repair of an isolated full-thickness supraspinatus tear were randomized to receive either standardized rehabilitation combined with KT or standardized rehabilitation alone. Postoperative pain intensity was the primary outcome. Secondary outcomes included shoulder range of motion, postoperative edema, Constant-Murley Score, QuickDASH score, and postoperative complications. Participants were assessed preoperatively and on postoperative day 1, week 2, week 6, and month 3.

Central Neuromuscular Dysfunction, Functionality, Psychological Status and Rotator Cuff Surgery

Considering the fact that The problems experienced by the patients are not only physiological but also psychological and social. Unfortunately, there is no sufficient study focus on all these concepts. Generally, studies focus on only physiological dimensions such as functional level, muscle strength and pain. The aim of this study, in addition to assessment methods commonly used for functional level, muscle strength and pain, is to evaluate central neuromuscular function on individuals who have undergone rotator cuff tear surgery with transcranial magnetic stimulation. Furthermore, psychological resilience, which is considered as a positive psychological trait, will also be evaluated. Until now, only one study has evaluated the role of psychological resilience in the postoperative process of rotator cuff surgery. This study has shown that the correlation between functionality and psychological resilience. As a result of our study, the influence of resiliency on postoperative outcomes following rotator cuff surgery will be determined and central neuromuscular function, shoulder functional level, and psychological resilience changes will be revealed in physiological and psychological concepts. Furthermore, this study may show that psychological resilience has a potential role on predicting functional level and pain. It is planned that the results obtained will guide the postoperative rehabilitation of rotator cuff surgery for further studies on multidimensional perspectives.

Exactech Shoulder Post Market Clinical Follow-up Study

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

MRI Evaluation of Integrity Implant for Rotator Cuff Tears

The goal of this observational study is to evaluate the effectiveness and safety of the Integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. The main questions it aims to answer are: * How does the application of the Integrity implant affect patient-reported outcome measures (PROMs) such as ASES, SANE, and PROMIS? * What are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the Integrity implant? Postoperative MRIs will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the Integrity implant at 3 and 6 months after surgery. Participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. They may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.

Perianchor Cyst Formation, Tendon Healing, and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

Perianchor cyst formation is frequently observed after arthroscopic rotator cuff repair; however, its clinical significance remains unclear. This study aims to evaluate the relationship between anchor-related parameters and cyst formation, as well as their association with tendon healing and functional outcomes.

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.

Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study

The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are: * What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and * What is the rate of surgical revisions needed over a 10 year period Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.

Biomarkers to Predict Rotator Cuff Repair Healing on Postoperative MRI

Rotator cuff repair healing is highly variable with healing failure rates ranging from 11 to 94%. To this date, there are no specific biomarkers in shoulder tissues that can be associated with rotator cuff healing after surgery. The purpose of this study is to perform diagnostic imaging study (MRI without contrast), for research purposes, to subjects in the Orthopedics Biobank (IRB#202403832), to identify biomarkers associated with failure of rotator cuff repair healing. We will evaluate biomarkers in synovial fluid and shoulder tissues collected and analyzed as part of the IRB#202403832, and correlate the difference in biomarkers in patients that did and did not have signs of healing in the MRI. Secondarily, we aim to develop a model using demographics, radiographic parameters/MRI measurements and biomarkers to accurately predict rotator cuff repair healing rates at 1-year following surgery. This will be a study from a population of patients who are enrolled in the Orthopedic biorepository under IRB #202403832. Patients who underwent a rotator cuff repair will be invited to get an MRI without contrast of their operated shoulder at a period between 6 months to 1 year post-operative.

Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair

The goal of this clinical trial is to verify the effect of suprascapular nerve block and axillary nerve block in relieving postoperative pain after arthroscopic rotator cuff repair. Are there differences in visual analog pain scale and patient's satisfaction? Are there differences in mean plasma pain related cytokines? The participants will undergo preemptive ultrasound guided suprascapular nerve block and axillary nerve block using each 0.75% ropivacaine 10mL or each 0.9% saline 10mL.

E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults

This is a phase 1b investigator-initiated clinical trial that will evaluate the safety and feasibility of E-CEL UVEC® cells with the aim of improving outcomes for patients with full-thickness rotator cuff tears who undergo arthroscopic surgical repair. Allogeneic E-CEL UVEC cells will be delivered to the tendon repair site and to the muscle adjacent to the tendon repair site.

Longitudinal Change in Depression Severity and Clinical Outcomes After Arthroscopic Rotator Cuff Repair

This prospective cohort study evaluated how depressive symptom severity changes during the first 2 years after arthroscopic rotator cuff repair, and whether changes in depressive symptoms are associated with improvements in shoulder pain and function. Adults who underwent arthroscopic suture-bridge repair for a symptomatic full-thickness rotator cuff tear were classified by preoperative Hamilton Depression Rating Scale (HDRS) score as having depressive symptoms (HDRS ≥8) or not (HDRS ≤7). Depressive symptom severity (HDRS), shoulder pain (visual analog scale), and shoulder function (American Shoulder and Elbow Surgeons score and Constant score) were assessed before surgery and at 3, 6, 12, and 24 months after surgery. Integrity of the repaired tendon was evaluated with ultrasonography at 24 months.

Randomized Study of an Analgesic Device Enabling Local Anesthetic Delivery and Neuromodulation After Shoulder/Foot Surgery

Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to investigate the post-operative analgesic potential of this investigational device and prepare for a pivotal multicenter clinical trial.

Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.