Clinical trials: Shoulder Arthroplasty
Blood Loss, Anatomic Total Shoulder Arthroplasty
Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty
To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total…
- Conditions
- Blood Loss, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty, Transfusion
- Trial name
- NCT02569658
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Fracture of Shoulder and Upper Arm
Exparel for Postoperative Pain Management in Shoulder Surgery
The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
- Trial name
- NCT02472314
- Testing
- 1.3% Liposomal Bupivacaine, 0.125% Bupivacaine
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Wayne State University
Osteoarthritis, Arthropathy
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements.
- Conditions
- Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part
- Trial name
- NCT02762071
- Testing
- Liposomal bupivacaine, Interscalene Nerve Block
- Where
- 2 sites in United States
- Volunteers
- 108 people
- Sponsor
- Johns Hopkins University
Pain
Liposomal Bupivacaine in Total Shoulder Arthroplasty
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible.
- Trial name
- EXP-TSA (NCT02570022)
- Testing
- Liposomal bupivacaine, Inter-scalene nerve block, Ropivacaine
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
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
Rotator Cuff Injuries, Shoulder Pain
ASHCOM Shoulder System and Its Related Instruments
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
- Trial name
- NCT04258605
- Testing
- ASHCOM Shoulder System
- Where
- Italy
- Volunteers
- 24 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 Joint Disease, Complications; Arthroplasty
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo…
- Conditions
- Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
- Trial name
- TXA (NCT02043132)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Corewell Health East
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
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
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
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
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
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Posttraumatic Arthrosis
Sidus Stem-Free Shoulder IDE Study
The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
- Conditions
- Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
- Trial name
- NCT01878253
- Testing
- Sidus Stem-Free Total Shoulder Arthroplasty System
- Where
- 11 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Zimmer Biomet
Anatomic Total Shoulder Arthroplasty
Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative…
- Trial name
- IRI (NCT01801241)
- Testing
- Anatomic TSA using IRI Instrumentation, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- The Cleveland Clinic
Acute Pain
Liposome Bupivacaine Interscalene Total Shoulder
This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine alone in interscalene blocks when undergoing…
- Trial name
- NCT03587636
- Testing
- liposome bupivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
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
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