Clinical trials: Arthroplasty, Replacement, Shoulder
Rotator Cuff Tear Arthropathy, Rotator Cuff Tear
Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods - abduction shoulder brace versus simple arm sling - following 2 common…
- Trial name
- NCT03488433
- Testing
- Abduction brace, Antirotation sling
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Nausea, Emesis
Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Nausea after surgery may negatively influence patient satisfaction, may delay discharge, and cause unexpected hospital admissions.
- Trial name
- NCT02602080
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Hospital for Special Surgery, New York
Arthropathy Shoulder
TXA in Revision Total Shoulder Arthroplasty
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group…
- Trial name
- NCT04650698
- Testing
- Tranexamic acid (TXA) injection
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NYU Langone Health
Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty
PaRIS-IOR is a prospective observational study that aims to collect and analyze functional outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder arthroplasty at the IRCCS Rizzoli Orthopedic…
- Conditions
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Shoulder
- Trial name
- PaRIS-IOR (NCT03790267)
- Testing
- Questionnaire administration
- Where
- Italy
- Volunteers
- 4,260 people
- Sponsor
- Istituto Ortopedico Rizzoli
Total Shoulder Arthroplasty
Exparel for Total Shoulder Arthroplasty
The primary objective of this study is to determine if Exparel leads to better pain scores at 24, 48 and 72 hours after Total Shoulder Arthroplasty (TSA) compared to a pain pump.
- Trial name
- NCT04364867
- Testing
- Exparel, Pain Pump
- Where
- United States
- Volunteers
- 102 people
- Sponsor
- Norton Healthcare
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
Glenohumeral Osteoarthritis
Poly vs Hybrid Glenoid in Stemless aTSA
Participants are randomized 1:1 to receive either a cemented all-polyethylene pegged glenoid or a hybrid trabecular titanium-pegged glenoid during anatomic total shoulder arthroplasty.
- Trial name
- Poly vs hybrid (NCT07520721)
- Testing
- Anatomic total shoulder arthroplasty with cemented all-polyethylene pegged glenoid, Anatomic total shoulder arthroplasty with hybrid trabecular titanium central-peg glenoid
- Where
- Netherlands
- Volunteers
- 94 people
- Sponsor
- Spaarne Gasthuis
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
Osteoarthritis of the Shoulder
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical.
- Trial name
- NCT04468178
- Testing
- Total joint arthroplasty of the glenohumeral joint
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Hannover Medical School
Shoulder Arthritis, Shoulder Osteoarthritis
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis
- Trial name
- NCT05314387
- Testing
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Volunteers
- 100 people
- Sponsor
- Limacorporate S.p.a
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