Clinical trials: 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
Subscapularis Peel, Morselized Osteotomy
Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
- Trial name
- NCT00508105
- Testing
- subscapularis peel, osteotomy
- Where
- Canada
- Volunteers
- 87 people
- Sponsor
- Ottawa Hospital Research Institute
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
Arthroplasty, Hemiarthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System
This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites.
- Conditions
- Arthroplasty, Hemiarthroplasty, Shoulder Pain
- Trial name
- NCT04089371
- Testing
- ReUnion Total Shoulder Arthroplasty (TSA), ReUnion Reverse Shoulder Arthroplasty (RSA)
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Stryker Trauma and Extremities
Glenohumeral Joint Degeneration
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
- Trial name
- NCT02768597
- Testing
- ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset, ReUnion System with a Large-Diameter Glenosphere +6 mm offset
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Mayo Clinic
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
Osteoarthritis, Hip Arthropathy
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
The objective of this study is to evaluate the efficacy of topical tranexamic acid (TXA) in decreasing blood loss following both shoulder arthroplasty and primary total hip arthroplasty.
- Conditions
- Osteoarthritis, Hip Arthropathy, Shoulder Arthropathy
- Trial name
- NCT01937559
- Testing
- Tranexamic acid (TXA), Normal saline
- Where
- United States
- Volunteers
- 188 people
- Sponsor
- The Hawkins Foundation
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
Fracture
Anatomical Shoulder™ Fracture PMCF Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02465398
- Testing
- Fracture Shoulder Arthroplasty
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
TSA, Bruise
Natural History of Pain After Shoulder Arthroplasty Conducted With Multimodal Analgesia
This study aims to identify the timeline of pain following total shoulder replacement with the goal of developing data for a subsequent randomized trial.
- Conditions
- TSA, Bruise, Pain, Postoperative
- Trial name
- TSA (NCT03021096)
- Testing
- Surveys
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Hospital for Special Surgery, New York
Shoulder Arthropathy, Shoulder Pain
Opioid-Free Pain Protocol After Shoulder Arthroplasty
This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty.
- Trial name
- NCT05488847
- Testing
- Celecoxib, Pregabalin, Tramadol
- Where
- United States
- Volunteers
- 83 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
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