Clinical trials: Total Shoulder Arthroplasty
Osteoarthritis, Inflammatory Arthritis
Rotator Cuff Sparing Total Arthroplasty
Design: Prospective, randomized clinical trial, of 120 patients requiring a total shoulder replacement (TSR). Purpose: To collect and evaluate long-term clinical data on patients whose total shoulder replacement (TSR) is…
- Trial name
- NCT01961986
- Testing
- TSR - traditional subscapularis release, TSR - rotator cuff sparing
- Where
- United States
- Volunteers
- 108 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
Osteoarthritis Shoulder, Rotator Cuff Tears
DenCT Shoulder Bone Quality Evaluation
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
- Trial name
- NCT06032416
- Testing
- Preoperative CT Scan
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Arthroplasty, Replacement, Shoulder, Arthritis Shoulder
Three Year Outcomes After Shoulder Arthroplasty
The purpose of this multicenter observational cohort study is to evaluate three-year outcomes in adults who underwent anatomic or reverse total shoulder arthroplasty using a contemporary shoulder implant system.
- Conditions
- Arthroplasty, Replacement, Shoulder, Arthritis Shoulder, Rotator Cuff Arthropathy
- Trial name
- NCT07815535
- Where
- 5 sites in United States
- Volunteers
- 300 people
- Sponsor
- Vani Sabesan
Osteo Arthritis Shoulders, Osteoarthritis Shoulder
Endogenous Pain Modulation Study
Rationale: Although most patients experience significant pain relief after total shoulder arthroplasty (TSA), pain persists for some patients even after surgery.
- Trial name
- EPM (NCT05861960)
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Reinier Haga Orthopedisch Centrum
Orthopedic Disorder, Humerus Fracture
Early Versus Delayed Rehabilitation After Reverse Total Shoulder Arthroplasty for Proximal Humerus Fracture
Proximal humerus fractures can be a debilitating injury in the elderly, impacting the ability to function independently or complete activities of daily living due to pain and restricted shoulder motion.
- Conditions
- Orthopedic Disorder, Humerus Fracture, Shoulder Arthroplasty, Reverse Shoulder Replacement
- Trial name
- NCT06869343
- Testing
- Physical Therapy
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Virginia
Osteoarthritis of the Shoulder
Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction
The overall objective of this study is to compare the clinical benefit and safety of two different surgical techniques of primary reverse total shoulder arthroplasty for the treatment of shoulder pseudoparalysis from chronic…
- Trial name
- NCT01697865
- Testing
- Transfer group, Control group
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Cutibacterium Acnes Contamination
Wound Irrigation Comparative Effectiveness Study
The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline…
- Trial name
- NCT06379919
- Testing
- Irrisept Irrigation, Saline Irrigation Solution Delivery
- Where
- United States
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Orthopaedic Education and Research Institute (dba Hoag Orthopedics)
Postoperative Pain
Propofol Versus Sevoflurane on Acute Postoperative Pain
This study was performed to compare the acute postoperative pain intensity and opioid consumption after total shoulder arthroplasty between propofol-remifentanil and sevoflurane-remifentanil anesthesia.
- Trial name
- NCT04333992
- Testing
- propofol and remifentanil, sevoflurane and remifentanil
- Where
- South Korea
- Volunteers
- 48 people
- Sponsor
- Yeungnam University College of Medicine
Opioid Use, Shoulder Osteoarthritis
Opioid-Free Shoulder Arthroplasty
Purpose of Study: To identify and provide a safe, opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
- Conditions
- Opioid Use, Shoulder Osteoarthritis, Avascular Necrosis, Rotator Cuff Tear
- Trial name
- NCT03540030
- Testing
- Gabapentin, Celecoxib, toradol
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- OrthoCarolina Research Institute, Inc.
Total Shoulder Arthroplasty, Osteo Arthritis Shoulders
Posterior Approach to Total Shoulder Arthroplasty
The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes.
- Trial name
- pTSA (NCT03623269)
- Testing
- posterior approach to total shoulder arthroplasty
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- The Orthopaedic Research & Innovation Foundation
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
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
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03726554
- Testing
- Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Zimmer Biomet
Arthritis
The Effect of Music Therapy Intervention on Pain and Anxiety in Adult Patients Undergoing Total Shoulder Arthroplasty
The purpose of this study is to determine if music therapy interventions as adjunct to standard surgical care reduces pre- and post-operative pain and anxiety in patients undergoing total shoulder arthroplasty as compared with…
- Trial name
- NCT02692768
- Testing
- Live Music Therapy, Recorded Music Therapy, Control
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- April Armstrong
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
Pain, Postoperative
Liposomal Bupivacaine Versus Interscalene Nerve Block
The aim of this study is to compare two different pain management interventions in patients undergoing reverse total shoulder arthroplasty.
- Trial name
- NCT03929146
- Testing
- Exparel, Interscalene Nerve Block
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study…
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- Trial name
- NCT04968405
- Testing
- Catalyst CSR Total Shoulder System
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Catalyst OrthoScience
Shoulder Arthropathy Associated With Other Conditions
Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear…
- Trial name
- NCT03430167
- Testing
- home therapy, formal therapy
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Washington University School of Medicine
Total Shoulder Arthroplasty, Rotator Cuff Tears
Ultrasound After Total Shoulder Arthroplasty
The purpose of this study would be to evaluate a group of patients status post post-total shoulder arthroplasty to assess the integrity of the rotator cuff using ultrasound.
- Conditions
- Total Shoulder Arthroplasty, Rotator Cuff Tears, Rotator Cuff Injuries
- Trial name
- NCT04416932
- Testing
- Ultasound
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Duke University