Clinical trials: Total Shoulder Arthroplasty
Cerebral Ischemia
Total Shoulder Arthroplasty Near-infrared Spectroscopy
The purpose of this study is to measure cerebral oxygenation and cardiac output of total shoulder replacement patients undergoing general anesthesia (GA) and positive-pressure ventilation (PPV).
- Trial name
- TSA NIRS (NCT02198183)
- Testing
- Casmed Fore-Sight Elite, Non-invasive Cardiac Output Monitor (NICOM)
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Hospital for Special Surgery, New York
Shoulder Arthropathy
Quality of Life, Functional Outcomes and Costs in Shoulder Arthroplasty
This prospective observational study aims to collect and analyse data on functional outcomes, quality of life indicators, and costs in patients undergoing primary total shoulder arthroplasty (shoulder replacement) surgery.
- Trial name
- NCT05940974
- Testing
- Questionnaire administration
- Where
- Russia
- Volunteers
- 12 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Shoulder Pain
Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus…
- Trial name
- NCT03913091
- Testing
- Liposomal Bupivacaine, 0.5% Bupivacaine HCL
- Where
- United States
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Arthritis
Total Shoulder Replacement Outcomes With Autologous Bone Graft as Fixator for Glenoid Anchor Peg.
We hypothesize that there will be a low incidence of glenoid loosening with a total shoulder arthroplasty using an anchor peg glenoid and autologous bone grafting.
- Trial name
- Glenoid (NCT02136251)
- Sponsor
- University of Nebraska
Joint Disease
Comprehensive Shoulder System Nano IDE
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
- Trial name
- Nano (NCT01936259)
- Testing
- Mini Stem, Nano
- Where
- 12 sites in United States
- Volunteers
- 258 people
- Sponsor
- Zimmer Biomet
Shoulder Injuries
Increased Home-based Physical Therapy Adherence Using BAND Connect's VirtuaCare™ Platform
This study aims to enhance at-home therapy by introducing a new device called the BAND Connect's VirtuaCare™ platform. The study aims to determine whether patients can improve their adherence to at-home exercises using this…
- Trial name
- NCT05876208
- Testing
- BAND Connect's VirtuaCare™ platform, Standard of Care Physical Therapy
- Where
- United States
- Volunteers
- 77 people
- Sponsor
- University of Cincinnati
Post Operative Pain, Anesthesia
Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties
Comparison of post-operative pain after total shoulder surgery. The Principle Investigator will be comparing Exparel single shot block to Interscalene catheter
- Conditions
- Post Operative Pain, Anesthesia, Nerve Block, Shoulder Osteoarthritis
- Trial name
- NCT05868330
- Testing
- Interscalene Catheter, Exparel Single Shot Interscalene Block
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Melinda Seering
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
Total Shoulder Arthroplasty
Patient Specific Instruments Versus Standard Surgical Instruments
Comparison of Glenoid Component Position Using Patient Specific Instruments Versus Standard Surgical Instruments: A Randomized Prospective Clinical Trial
- Trial name
- TIOSO-GPS (NCT01430468)
- Testing
- Glenoid Positioning System
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- The Cleveland Clinic
Osteoarthritis of the Shoulder, Shoulder Pain
Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.
- Conditions
- Osteoarthritis of the Shoulder, Shoulder Pain, Pain, Postoperative
- Trial name
- NCT04134442
- Testing
- Bupivacaine Liposome Injection, Standard Therapy
- Where
- United States
- Sponsor
- University of Massachusetts, Worcester
Shoulder Fractures, Shoulder Arthritis Osteoarthritis
Zimmer Biomet Shoulder Arthroplasty PMCF Study
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in…
- Conditions
- Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain
- Trial name
- NCT06920459
- Testing
- Alliance™ Glenoid
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Shoulder Arthritis, Blood Loss, Surgical
Effect of TXA on Blood Loss in Reverse Total Shoulder Arthroplasty
Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that has been well studied and routinely used for hip and knee arthroplasty.
- Conditions
- Shoulder Arthritis, Blood Loss, Surgical, Tranexamic Acid Adverse Reaction
- Trial name
- NCT06638749
- Testing
- Tranexamic Acid, Normal Saline
- Where
- United States
- Sponsor
- University of Kansas Medical Center
Primary Generalized (Osteo)Arthritis, Post-traumatic Arthrosis of Other Joints, Upper Arm
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
- Trial name
- NCT01390038
- Testing
- Simpliciti™ Shoulder System
- Where
- 14 sites in United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Total Shoulder Arthroplasty
Subscapularis-Sparing Total Shoulder Arthroplasty
The investigators purpose of this study are to perform a prospective clinical study to determine the following after subscapularis-sparing anatomic total shoulder arthroplasty performed for glenohumeral osteoarthritis: 1.
- Trial name
- NCT07410650
- Testing
- Subscapularis-Sparing Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Utah
Shoulder Arthritis, Anesthesia, Local
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial
Total shoulder arthroplasty (TSA) is a common and effective treatment for end-stage shoulder pathologies. Over the past 25 years, implant designs have evolved and the indications for joint replacement have expanded significantly…
- Conditions
- Shoulder Arthritis, Anesthesia, Local, Local Infiltration
- Trial name
- NCT05908851
- Testing
- 100 mL of 0.9% normal saline (57ml), 0.5% ropivacaine (40 ml), 10 mg morphine (10 mg/ml), 0.1 mg of epinephrine (0.1 mg/ml), and 30 mg of ketorolac (30 mg/ml)
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Shoulder Injuries
IO Vancomycin in TSA
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic…
- Trial name
- NCT05831774
- Testing
- Intervention - Intraosseous (IO) administration of vancomycin, Control - Standard IV administration of vancomycin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- The Methodist Hospital Research Institute
Shoulder Arthroplasty
Total Shoulder Arthroplasty Multi-Center Registry
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
- Trial name
- NCT03511586
- Where
- 27 sites in United States, Germany and 2 more
- Volunteers
- 2,500 people
- Sponsor
- Arthrex, Inc.
Shoulder Arthroplasty
Prospective Low Dose CT for Total Shoulder Arthroplasty/Reverse Shoulder Arthroplasty
This study is a prospective, departmental funded study examining the outcomes of simulated Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University for total shoulder arthroplasty or…
- Trial name
- NCT05350319
- Testing
- A low-dose CT scan of the shoulder
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Duke University
Reverse Shoulder Replacement
EMG Biofeedback and NMES of Deltoid in Patients With rTSA
The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA
- Trial name
- NCT06873022
- Testing
- neuromuscular electrical stimulation, biofeedback
- Where
- Taiwan
- Volunteers
- 34 people
- Sponsor
- National Taiwan University Hospital
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet