Clinical trials: Arthroplasty, Replacement, Shoulder
Humerus Fracture, Humerus
RSA vs. Nonop for 3 & 4-Part Proximal Humerus Fractures
There is currently no consensus amongst orthopedic specialists on the best way to treat 3- and 4-part proximal humerus fractures.
- Conditions
- Humerus Fracture, Humerus, Shoulder Fractures, Shoulder Arthropathy Associated With Other Conditions
- Trial name
- NCT03599336
- Testing
- Reverse Total Shoulder Arthroplasty (rTSA), Nonoperative Treatment
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Mayo Clinic
Total Shoulder Arthroplasty, Postoperative Pain
Total Shoulder Arthroplasty Preoperative Pain Threshold and Association With Postoperative Opioid Consumption
The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption…
- Conditions
- Total Shoulder Arthroplasty, Postoperative Pain, Opioid Use
- Trial name
- NCT06133933
- Testing
- Pain Threshold using algometer/dolorimeter
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- The Cooper Health System
Total Shoulder Arthroplasty
Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder.
- Trial name
- NCT02143245
- Testing
- Synovial Biopsy, Open Tissue Biopsy
- Where
- 4 sites in Canada
- Volunteers
- 118 people
- Sponsor
- Ottawa Hospital Research Institute
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
Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus
Easytech Reversed Shoulder System Clinical Study
The purpose of the study is to collect data to demonstrate the safety and effectiveness of the Easytech Reversed Shoulder System for the treatment of patients who require a reverse total shoulder arthroplasty.
- Conditions
- Osteo Arthritis Shoulders, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT03806842
- Testing
- Easytech group
- Where
- 6 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- FX Shoulder Solutions
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
Arthroplasty, Replacement
PRIMA EU Retrospective & Prospective
This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the…
- Conditions
- Arthroplasty, Replacement, Shoulder
- Trial name
- NCT06371833
- Testing
- Shoulder Arthroplasy with PRIMA humeral stem
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Limacorporate S.p.a
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
Rotator Cuff Injuries, Anesthesia; Functional
The Impact of a Preoperative Nerve Block on the Consumption of Sevoflurane in Total Shoulder Arthroplasty
Total arthroplasty surgery of the shoulder is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves.
- Trial name
- NCT04020601
- Testing
- Ropivacaine, Dextrose
- Where
- Canada
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Alberta
Shoulder Osteoarthritis
Subscapularis Strength After Total Shoulder Arthroplasty
This is a randomized, double-blinded, standard of care-controlled clinical trial. The purpose of this study is to determine the difference in subscapularis strength and function after anatomic Total Shoulder Arthroplasty (aTSA)…
- Trial name
- NCT03854357
- Testing
- Subscapularis Rehabilitation, Standard Rehabilitation
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Proximal Humeral Fracture, Humeral Head Fracture
Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements
The optimal treatment of complex shoulder fracture is controversial. In general, non-surgical treatment is recommended for older patients, but results are often unsatisfying.
- Trial name
- NCT06444828
- Testing
- Non-operative
- Where
- Denmark
- Volunteers
- 90 people
- Sponsor
- University of Southern Denmark
Shoulder Arthritis, Anesthesia, Local
Perioperative Pain Management for Total Shoulder Arthroplasty: A Pilot Non-Inferiority Trial
Total shoulder arthroplasty (TSA) is a common and effective treatment for end-stage shoulder pathologies. Over the past 25 years, implant designs have evolved and the indications for joint replacement have expanded significantly…
- Conditions
- Shoulder Arthritis, Anesthesia, Local, Local Infiltration
- Trial name
- NCT05908851
- Testing
- 100 mL of 0.9% normal saline (57ml), 0.5% ropivacaine (40 ml), 10 mg morphine (10 mg/ml), 0.1 mg of epinephrine (0.1 mg/ml), and 30 mg of ketorolac (30 mg/ml)
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Humeral Fracture, Proximal
Reverse Total Shoulder Arthroplasty Versus Hemiarthroplasty for Displaced 3- and 4-part Proximal Humeral Fractures
Proximal humeral fractures are common injuries with the highest incidence being amongst the elderly. Most proximal humeral fractures are nondisplaced or minimally displaced.
- Trial name
- NCT03383991
- Testing
- Reverse Total Shoulder Arthroplasty, Hemiarthroplasty
- Sponsor
- Karolinska Institutet
Rotator Cuff Tears, Anatomic Total Shoulder Arthroplasty
Innovating Physical Therapy: A Pilot Study on Band Connect's Impact on Compliance, Satisfaction, and Revenue
Participants are being invited to take part in this research study because you will be undergoing total shoulder replacement or rotator cuff repair and will be participating in physical therapy rehabilitation following the…
- Conditions
- Rotator Cuff Tears, Anatomic Total Shoulder Arthroplasty, Reverse Total Shoulder Arthroplasty
- Trial name
- NCT06733480
- Testing
- Band Connect
- Where
- United States
- Volunteers
- 499 people
- Sponsor
- University Hospitals Cleveland Medical Center
Closed Fracture Proximal Humerus, Four Part
Reverse Total Shoulder Arthroplasty Versus Open Reduction Internal Fixation of 3&4 Part Proximal Humerus Fractures
Will patients who suffer complex humerus fractures have better functional outcomes and less implant failure with shoulder replacement (reverse total shoulder arthroplasty, RTSA) compared to shoulder repair (open reduction and…
- Trial name
- NCT02597972
- Testing
- Fracture repair, Fracture repair with joint replacement
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Mayo Clinic
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
Arthroplasty, Replacement
SMR Stemless Reverse vs SMR Reverse Shoulder System
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
- Trial name
- NCT04697004
- Testing
- Investigational Arm: SMR Stemless Reverse, Control Arm: SMR Reverse Shoulder System
- Where
- 13 sites in United States
- Volunteers
- 200 people
- Sponsor
- Limacorporate S.p.a
Arthroplasty, Replacement, Shoulder
S-33 SMR Shoulder HP Reverse Glenosphere
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision…
- Trial name
- NCT05339815
- Testing
- SMR shoulder arthroplasty
- Where
- United Kingdom
- Volunteers
- 205 people
- Sponsor
- Limacorporate S.p.a
Rotator Cuff Tear Arthropathy, Rotator Cuff Tear
Abduction Brace Versus Antirotation Sling for Immobilization Following Reverse Shoulder Arthroplasty and Rotator Cuff Repair
To compare the functional and anatomical outcomes, and patient satisfaction and compliance between two different postoperative immobilization methods - abduction shoulder brace versus simple arm sling - following 2 common…
- Trial name
- NCT03488433
- Testing
- Abduction brace, Antirotation sling
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Milton S. Hershey Medical Center
Osteoarthritis of Glenohumeral Joint
Columbia Shoulder Study (CSS)
This prospective study will evaluate the Bigliani/Flatow prosthesis. The aims of this study are to establish the safety, effectiveness, and value of the prosthetic system, and to collect information from expert shoulder surgeons…
- Trial name
- CSS (NCT01488006)
- Testing
- Bigliani/Flatow Shoulder System
- Where
- United States
- Volunteers
- 207 people
- Sponsor
- Columbia University