Clinical trials: Arthroplasty Shoulder
Shoulder Injuries, Rotator Cuff Injuries
Subscap Reverse Shoulder Arthroplasty
The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial.
- Trial name
- NCT05344898
- Testing
- Subscap Tenotomy, Subscap Repair
- Where
- United States
- Volunteers
- 118 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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
Rate of Positive Culture Growth for C.Acnes From Specimens Obtained From the Shoulders of Patients Undergoing Primary Shoulder Arthroplasty
Irrisept C.Acnes Study
A Prospective, Randomized, Controlled Trial Comparing An Irrisept Antiseptic Irrigation With 0.05% Chlorhexidine Gluconate versus Standard of Care Prophylaxis Chlorohexidine Wipes
- Trial name
- NCT03938467
- Testing
- Antiseptic Cleanser
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Orthopaedic Associates of Michigan, PC
Subscapularis Peel, Morselized Osteotomy
Comparing Two Surgical Methods of Fixation of Subscapularis During Shoulder Arthroplasty
This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
- Trial name
- NCT00508105
- Testing
- subscapularis peel, osteotomy
- Where
- Canada
- Volunteers
- 87 people
- Sponsor
- Ottawa Hospital Research Institute
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
Reverse Shoulder Replacement
EMG Biofeedback and NMES of Deltoid in Patients With rTSA
The effect of NMES and surface electromyography (sEMG) biofeedback on the deltoid and associated scapular muscles in scapular kinematics and muscle activation in individual post rTSA
- Trial name
- NCT06873022
- Testing
- neuromuscular electrical stimulation, biofeedback
- Where
- Taiwan
- Volunteers
- 34 people
- Sponsor
- National Taiwan University Hospital
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
Proximal Humeral Fractures
Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Fractures of the Proximal Humerus
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
- Trial name
- NCT00835562
- Testing
- Non-surgical management, Osteosynthesis, Hemiarthroplasty
- Where
- Denmark
- Volunteers
- 162 people
- Sponsor
- Herlev Hospital
Opioid Use
Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm
The investigators aim to better understand opioid use in patients undergoing elective shoulder surgery. The investigators will prospectively determine actual postoperative opioid use, while evaluating whether implementation of an…
- Trial name
- NCT03808025
- Testing
- opioid education
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of California, Davis
Glenohumeral Osteoarthritis
Anatomic Versus Reverse Shoulder Arthroplasty for Primary Glenohumeral Osteoarthritis
The primary goal of the investigators prospective randomized study is to determine whether reverse total shoulder arthroplasty (RTSA) have at least as good results as anatomic TSA (non-inferiority), in patients with glenohumeral…
- Trial name
- NCT06513559
- Testing
- Anatomic total shoulder replacement, Reverse total shoulder replacement
- Where
- United States
- Sponsor
- University of Utah
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
Arthropathy Shoulder
The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty
The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes.
- Trial name
- NCT03727490
- Testing
- Repair, Standard Treatment
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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
Osteoarthritis
Electromyography Evaluation of Subscapularis Function After Total Shoulder Arthroplasty
The primary objective is to document function of the structurally intact subscapularis after total shoulder arthroplasty by using electromyography. Structural integrity of the subscapularis will be confirmed using ultrasound.
- Trial name
- NCT00779974
- Testing
- Evaluation
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Milton S. Hershey Medical Center
Rebound Pain, Shoulder Arthroplasty
Effect of Local Anesthetic Concentration on Rebound Pain
Randomized control study that compares different concentrations of local anesthetic to investigate whether a lower concentration of local anesthetic would contribute to lower rebound pain scores at 24 hours post op in patients…
- Conditions
- Rebound Pain, Shoulder Arthroplasty, Interscalene Block
- Trial name
- RPRCT (NCT07146685)
- Testing
- Bupivacaine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Virginia
Arthropathy Shoulder
Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)
The shoulder is a site particularly affected by osteoarthritis since it affects up to 7% of the population aged over 65. To deal with osteoarthritis, total shoulder prosthesis is an increasingly used solution.
- Trial name
- SCAP-imag (NCT06877936)
- Testing
- EOS exam, Questionnaires Constant et ASES
- Where
- France
- Volunteers
- 25 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
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
Rotator Cuff Arthropathy
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial.
- Trial name
- REACT (NCT04864158)
- Testing
- TSA-group, Exercise-group
- Where
- 8 sites in Denmark, Estonia and 2 more
- Volunteers
- 102 people
- Sponsor
- University of Aarhus
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
Arthroplasty, Replacement, Shoulder, Shoulder Osteoarthritis
Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if…
- Trial name
- CARS-1 (NCT06025331)
- Testing
- BIO-RSA, RSA
- Where
- 2 sites in Norway
- Volunteers
- 130 people
- Sponsor
- Lovisenberg Diakonale Hospital