Clinical trials: Total Shoulder Arthroplasty
Pain, Postoperative
Analgesic Efficacy of Interscalene Nerve Block Versus Local Infiltration Analgesia Following Total Shoulder Arthroplasty
Total shoulder arthroplasty (TSA) is considered to be a major surgical procedure resulting in severe postoperative pain, especially in the first 48 hours after surgery.
- Trial name
- NCT02876055
- Testing
- Single shot interscalene nerve block, Continuous interscalene nerve block, Local Infiltration Analgesia (LIA)
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Anatomic Total Shoulder Arthroplasty
Comparison of Glenoid Position Using SmartBones
The investigators propose a randomized clinical trial to evaluate the accuracy of glenoid implant placement comparing four groups of patients.
- Trial name
- NCT03035318
- Testing
- DePuy Global® Anchor Peg Glenoid Instrumentation, DePuy Global® Anchor Peg Instrumentation with SmartBone™, IRI with SmartBone™
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- The Cleveland Clinic
Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
Effects on Postoperative Pain of Liposomal Bupivacaine in Interscalene Blocks for Total Shoulder Arthroplasty Patients
The purpose of this trial is to compare the difference in the proportion of patients with tolerable pain scores, VAS pain scores, quality of recovery and opioid use in milligram equivalents (at 24, 48, 72, 96 and 120 hours…
- Trial name
- NCT05900427
- Testing
- Liposomal bupivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Johnny K. Lee
Rotator Cuff Arthropathy, Failed Total Shoulder
Reverse Shoulder Prosthesis Study
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator…
- Conditions
- Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
- Trial name
- RSP (NCT00764504)
- Testing
- Reverse Shoulder Prosthesis
- Where
- 25 sites in United States
- Volunteers
- 516 people
- Sponsor
- Encore Medical, L.P.
Surgery, Surgical Site Infection
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after…
- Conditions
- Surgery, Surgical Site Infection, Cutibacterium Acnes, Prosthetic-joint Infection
- Trial name
- NCT05919888
- Testing
- Povidone-Iodine, SURGX Wound Gel
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- St. Louis University
Shoulder Injuries, Patient Satisfaction
Conjoint Tendon Resection During Reverse Total Shoulder Arthroplasty
Reverse total shoulder arthroplasty (RTSA) can reliably restore active forward elevation, abduction, and external rotation, which are often lost in patients with massive rotator cuff tears.
- Conditions
- Shoulder Injuries, Patient Satisfaction, Internal Rotation Contracture-shoulder
- Trial name
- NCT05753904
- Testing
- Conjoint Tendon Resection
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Pain
Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia
- Trial name
- NCT02713230
- Testing
- bupivacaine liposome injectable suspension
- Where
- 20 sites in United States, Belgium and 1 more
- Volunteers
- 156 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
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 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
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
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
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
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
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
Rotator Cuff Tear Arthropathy
Impact of Humeral Component Version on Outcomes Following RTSA
The proposed study is a prospective, single-blinded, randomized trial to investigate the impact of humeral component version on shoulder range of motion and patient reported functional outcomes following reverse total shoulder…
- Trial name
- NCT03111147
- Testing
- 0 degrees humeral component version, 30 degrees humeral component retroversion
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Corewell Health East
Total Shoulder Arthroplasty
Interscalene Dynamometer Pilot Study
Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain. Commonly, patients receive general anesthesia with interscalene block (injection of local anesthetic or numbing medicine near nerves in the…
- Trial name
- NCT01550952
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hospital for Special Surgery, New York
Pain, Postoperative, Brachial Plexus Block
Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty
This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.
- Trial name
- NCT05005260
- Testing
- Bupivacaine HCl, Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj
- Where
- United States
- Volunteers
- 88 people
- Sponsor
- Mayo Clinic