Clinical trials: SHOULDER ARTHROPLASTY
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)
Rotator Cuff Tear, Proximal Humerus Fractures
Clinical Outcome Comparison Between Medial and Lateral Offset Reverse Shoulder Arthroplasty
The purpose of this study is to prospectively evaluate two FDA approved implant designs for the Tornier Reverse Shoulder arthroplasty. The small difference in design is the amount of offset each implant has.
- Conditions
- Rotator Cuff Tear, Proximal Humerus Fractures, Malunions, Chronic Proximal Humerus Dislocations
- Trial name
- NCT01086202
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Loma Linda University
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
Reverse Shoulder Arthroplasty, Depressor Muscle Training
Strengthening Exercises for Humeral Head Depressor Muscles
Postoperative rehabilitation after reverse shoulder arthroplasty aims to improve pain control, range of motion, and functional capacity.
- Conditions
- Reverse Shoulder Arthroplasty, Depressor Muscle Training, Shoulder Rehabilitation
- Trial name
- NCT07309796
- Testing
- Conventional Rehabilitation Group, Depressor Muscle Strengthening Group
- Where
- Turkey (Türkiye)
- Volunteers
- 27 people
- Sponsor
- Hacettepe University
Technology, Comparison
Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty
The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques.
- Trial name
- NCT05615259
- Where
- 2 sites in Netherlands
- Volunteers
- 260 people
- Sponsor
- Exactech
Glenohumeral Joint Degeneration
Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.
- Trial name
- NCT02768597
- Testing
- ReUnion System with a Large-Diameter Glenosphere +2 mm offset, ReUnion System with a Small-Diameter Glenosphere +2 mm offset, ReUnion System with a Large-Diameter Glenosphere +6 mm offset
- Where
- United States
- Volunteers
- 113 people
- Sponsor
- Mayo Clinic
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Comprehensive Reverse Shoulder Data Collection
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03404778
- Testing
- Biomet Comprehensive Reverse Shoulder
- Where
- 4 sites in United States
- Volunteers
- 175 people
- Sponsor
- Zimmer Biomet
Arthroplasty Shoulder, Periprosthetic Joint Infection
Optimizing Infection Prophylaxis Prior to Shoulder Surgery
The goal of this interventional study is to determine the amount of skin C. acnes reduction with increased pressure during the chlorhexidine gluconate, brand name ChloraPrep, application.
- Trial name
- NCT06464770
- Testing
- Chlorhexidine Gluconate
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Washington
Shoulder Osteoarthritis
Comparison Between Anatomic Shoulder Arthroplasty, Hemiarthroplasty, and Reverse Shoulder Arthroplasty.
This study aims to evaluate outcomes in patients over 70 years of age who underwent anatomic shoulder arthroplasty, hemiarthroplasty, or reverse shoulder arthroplasty, focusing on revision rates, rotator cuff integrity as primary…
- Trial name
- NCT07060469
- Volunteers
- 110 people
- Sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Rotator Cuff Tears of the Shoulder
Integrity Implant System Post Market Clinical Follow-Up Study
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff…
- Trial name
- NCT06741527
- Testing
- Integrity Implant System
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Anika Therapeutics, Inc.
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT04003311
- Testing
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Arthropathy, Failed Total Shoulder
Reverse Shoulder Prosthesis Study
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator…
- Conditions
- Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
- Trial name
- RSP (NCT00764504)
- Testing
- Reverse Shoulder Prosthesis
- Where
- 25 sites in United States
- Volunteers
- 516 people
- Sponsor
- Encore Medical, L.P.
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
Rotator Cuff Tears
Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.
- Trial name
- NCT05333211
- Testing
- Ortho-R/PRP
- Where
- 9 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- ChitogenX Inc
Glenohumeral Osteoarthritis
Comparison of Stemless and Stemmed Shoulder Arthroplasty for Osteoarthritis
This is a randomized controlled trial comparing the Comprehensive Nano stemless total shoulder arthroplasty (intervention group) with the Comprehensive un-cemented stemmed total shoulder arthroplasty (control group).
- Trial name
- NCT04105478
- Testing
- Shoulder arthroplasty
- Where
- Denmark
- Volunteers
- 122 people
- Sponsor
- Herlev and Gentofte Hospital
Shoulder Disease
Short-Term Outcomes of Total Shoulder Arthroplasty Using the Titan Modular Total Shoulder System
The goals of total, reverse total and hemi shoulder arthroplasty are the same, to alleviate the patient's pain and obtain a full functional recovery.
- Trial name
- NCT03956316
- Testing
- Titan Modular Total Shoulder System
- Volunteers
- 25 people
- Sponsor
- OrthoIndy
Osteoarthritis
Global® AP™ Total Shoulder Arthroplasty
This study will evaluate the clinical performance of DePuy Global® AP™ Shoulder prosthesis using the anchor pegged glenoid component and clinical and radiographic evaluations.
- Trial name
- NCT00719771
- Testing
- Global® AP™ Total shoulder arthroplasty
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- DePuy Orthopaedics
Anxiety, Opioid Use
Effects of Hypnosis Therapy on Outcomes in Shoulder Replacement Therapy
The purpose of this study is to collect information to evaluate the role of the psychogenic component of pain induced by anxiety on postoperative outcomes in major orthopaedic surgery and to determine whether hypnosis therapy…
- Trial name
- NCT04889833
- Testing
- hypnosis therapy
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Foundation for Orthopaedic Research and Education
Osteoarthritis, Post-traumatic; Arthrosis
Long Term Sidus PMCF
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
- Trial name
- NCT04063943
- Testing
- Sidus Stem-Free Shoulder
- Where
- 7 sites in United States, Canada
- Sponsor
- Zimmer Biomet
Shoulder Arthritis
Study of Personalized Instrument in Total Shoulder Arthroplasty The P.I.T.S.A. Study
Total shoulder arthroplasty is an effective procedure to improve patients function and to relieve shoulder pain in cases of glenohumeral arthritis. The main challenge of this procedure is implanting the glenoid component.
- Trial name
- PITSA (NCT03839758)
- Testing
- TSA standard, RTSA standard, TSA Blueprint
- Where
- Canada
- Volunteers
- 112 people
- Sponsor
- Université de Montréal