Clinical trials: Shoulder Arthroplasty
Osteoarthritis
Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the "Epoca" System
The clinical question on whether or not to replace the glenoid component in patients with a degenerative shoulder disease, has not been answered yet in a randomized study with enough statistical power.
- Trial name
- Epoca H vs T (NCT01288066)
- Testing
- Hemiarthroplasty, Total arthroplasty
- Where
- 4 sites in Austria, Germany and 1 more
- Volunteers
- 76 people
- Sponsor
- AO Innovation Translation Center
Shoulder Injuries, Shoulder Pain
Reverse Shoulder Arthroplasty vs Rotator Cuff Repair for 60+
To compare the one year outcomes between 60 year old patients with a three tendon tear treated as part of their standard of care with either a reverse total shoulder arthroplasty or rotator cuff repair surgery.
- Trial name
- RTSA-RCR (NCT06848023)
- Testing
- Reverse Total Shoulder Arthroplasty, Rotator Cuff Repair
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Campbell Clinic
Total Shoulder Arthoplasty
TSA Versus RSA in Patients >75
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff.
- Trial name
- NCT04827277
- Testing
- Reverse Total Shoulder Replacement, Anatomic Total Shoulder Replacement
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
Rotator Cuff Arthropathy
Focus on the Humeral Component Following Reverse Shoulder Arthroplasty
Reverse total shoulder arthroplasty has been widely used in the treatment of rotator cuff arthropathy. Follow-up has historically focused on the glenoid component because of problems with fixation and scapular notching leading to…
- Trial name
- RSA (NCT04809077)
- Testing
- Reverse total shoulder replacement
- Where
- Belgium
- Volunteers
- 123 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Osteo Arthritis Shoulders
Air Barrier System for the Reduction of Airborne Colony-forming Units During Total Shoulder Arthroplasty
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g., bacteria) present at a surgery site during total shoulder arthroplasty surgeries.
- Trial name
- NCT03782675
- Testing
- Control, Air Barrier System
- Volunteers
- 40 people
- Sponsor
- Nimbic Systems, LLC
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)
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 Pain, Opioid Use
Multimodal Analgesia in Shoulder Arthroplasty
Opioid medications are associated with many side effects and the risk of abuse or overdose. Orthopaedic surgeons are currently investigating ways to control pain after surgery while limiting the amount of opioid medications…
- Trial name
- NCT03586934
- Testing
- Acetaminophen, Celecoxib 200mg, Celecoxib 400 mg
- Where
- United States
- Sponsor
- Rush University Medical Center
Shoulder Disease
Diaphragm-sparing Nerve Blocks for Shoulder Arthroplasty
The combination of a modified lateral sagittal infraclavicular block and a suprascapular nerve block has not been studied in a cohort of total arthroplasty patients.
- Trial name
- NCT03877835
- Testing
- Peripheral nerve blocks
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- University Hospital of North Norway
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
Pain, Shoulder
Comparison of Pain Relief After Non Stimulating Interscalene Catheter Placement vs Stimulating Catheter Placement in Total Shoulder Arthroplasty.
1. Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used. 2.
- Conditions
- Pain, Shoulder, Arthroplasty
- Trial name
- NCT01122732
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- University of Chicago
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
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
Reverse Shoulder Arthroplasty
Comparison of Lateralized RTSA With and Without Subscapularis Repair
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern…
- Trial name
- NCT04728282
- Testing
- RTSA with subscapularis repair, RTSA without subscapularis repair
- Where
- 6 sites in Canada
- Volunteers
- 284 people
- Sponsor
- Panam Clinic
Chronic Pain
Chronic Pain After Shoulder Arthroplasty
Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain…
- Trial name
- NCT01900223
- Volunteers
- 786 people
- Sponsor
- Karen Bjørnholdt
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
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System (BE)
This is a post-market surveillance study on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05002335
- Testing
- Medacta Shoulder System
- Where
- 3 sites in Belgium
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Rotator Cuff Tear Arthropathy
Subscapularis Repair in Reverse Shoulder Arthroplasty
This study will evaluate the subscapularis repair versus non-repair during a reverse shoulder arthroplasty (RSA).
- Trial name
- Subscap (NCT05438914)
- Testing
- Repair of the subscapularis
- Where
- 6 sites in United States
- Volunteers
- 134 people
- Sponsor
- Arthrex, Inc.
Arthroplasty Complications, Shoulder Osteoarthritis
Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
- Trial name
- CARS-2 (NCT06025448)
- Testing
- BIO-RSA, MIO-RSA
- Where
- Norway
- Volunteers
- 20 people
- Sponsor
- Lovisenberg Diakonale Hospital
Shoulder Surgery
Opiate Sparing Versus Opiate Based Following Shoulder Arthroplasty
To investigate the difference between an opiate sparing pain management protocol versus a standard opiate-based protocol following shoulder arthroplasty in the ninety day postoperative period regarding visual analog scores and…
- Trial name
- NCT04294680
- Testing
- Cryotherapy
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Campbell Clinic