Clinical trials: Arthroplasty, Replacement, Shoulder
Shoulder Arthroplasty
Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants
The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in…
- Trial name
- NCT03845894
- Testing
- Liposomal bupivacaine, Bupivacaine with adjuvants
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
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
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
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
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
Shoulder Arthritis, Shoulder Arthropathy Associated With Other Conditions
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.
- Trial name
- NCT03899753
- Testing
- 2-Octyl Cyanoacrylate and Mesh, 2-Octyl Cyanoacrylate
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
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
Osteoarthritis
Lesser Tuberosity Osteotomy for Subscapularis Repair
The primary objective of this study is to assess the clinical effectiveness of two different techniques used for subscapularis tendon repair during total shoulder replacement.
- Trial name
- NCT02762903
- Testing
- TSA with tenotomy technique, TSA with lesser tuberosity osteotomy technique, Shoulder prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
Osteoarthritis, Knee, Osteoarthritis, Hip
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder
- Trial name
- NCT02197273
- Testing
- Liposomal bupivacaine, Standard of care analgesia
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- OhioHealth
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, Shoulder Osteoarthritis
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia…
- Trial name
- NCT03969875
- Testing
- Interscalene catheter, Liposomal bupivacaine, Dexamethasone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Osteoarthritis, Rotator Cuff Tear Arthropathy
Prediction of Development of Scapular Notching Following Reverse Total Shoulder Arthroplasty
The hypothesis is that computer simulated bony impingement of the bone surrounding the spherical glenoid implant (the glenosphere) along the scapular neck on three-dimensional (3-D) computed tomography (CT) imaging analysis is…
- Conditions
- Osteoarthritis, Rotator Cuff Tear Arthropathy, Reverse Total Shoulder Arthroplasty, Scapular Notching
- Trial name
- NCT02052466
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Eric Ricchetti
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
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
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
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
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
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
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
Pain
Exparel Interscalene vs Indwelling Catheter
The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).
- Trial name
- NCT03827213
- Testing
- Exparel, Indwelling Interscalene Catheter
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Montefiore Medical Center