Clinical trials: Arthroplasty Shoulder
Postoperative Pain, Total Shoulder Arthroplasty
Cohort 1 (TSA) of: A Multi-surgery Assessment of ZYNRELEF (HTX-011)
Cohort 1 (subjects undergoing total shoulder arthroplasty, TSA) of a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical…
- Conditions
- Postoperative Pain, Total Shoulder Arthroplasty, Multimodal Analgesia
- Trial name
- AMAZE (NCT06109415)
- Testing
- HTX-011, Bupivacaine Hydrochloride, MMA regimen
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Heron Therapeutics
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 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
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
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion TSA System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03858517
- Testing
- ReUnion TSA System
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Stryker Trauma and Extremities
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 Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03880955
- Testing
- ReUnion RSA System
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Stryker Trauma and Extremities
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
Primary Anatomic or Reverse Total Shoulder Arthroplasty
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery.
- Trial name
- NCT04609306
- Testing
- H2O2 application to incision
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Florida
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
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
Post-operative Pain, Total Shoulder Arthroplasty
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients…
- Conditions
- Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management
- Trial name
- NCT03887650
- Testing
- Liposomal Bupivicaine 1.3%, Bupivacaine 0.5%
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Hartford Hospital
Mastectomy, Upper Limb Amputation Below Elbow
Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this…
- Conditions
- Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee
- Trial name
- NCT03578237
- Testing
- Cryoneurolysis (active)
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- University of California, San Diego
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
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
Anatomic Total Shoulder Arthroplasty
Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty
Glenoid component loosening is the most common complication of total shoulder arthroplasty. Loosening is associated with malposition of the implant as well as the quality of the glenoid bone.
- Trial name
- RTI (NCT01905241)
- Testing
- Anatomic TSA using RTI, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland 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
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
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, 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