Clinical trials: Total Shoulder Arthroplasty
Total Shoulder Arthroplasty
Glenosphere Size and Scapular Notch in RSA, Prospective Randomized Study
Scapular notch can be reduced by using bigger glenospheres but in some patients it cannot be implanted because of small size. If small size of glenosphere is used then scapular notch may increase.
- Trial name
- GSSNRSA (NCT03730597)
- Testing
- reverse shoulder arthroplasty
- Volunteers
- 95 people
- Sponsor
- Hospital del Mar
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
Post-Operative Pain
Comparison of Pulmonary Function and Efficacy of Different Nerve Block Catheters for Shoulder Surgery
This study is designed to evaluate lung function and pain control of continuous supraclavicular versus suprascapular versus interscalene nerve catheters in subjects undergoing total shoulder replacement.
- Trial name
- NCT02117778
- Testing
- Continuous Nerve Block
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Benaroya Research Institute
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
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 Arthroplasty
Assessment of Posterior Subluxation of the Humeral Head Using Biplanar Imaging in the Upright Position in Patients Scheduled for Total Shoulder Arthroplasty
Total shoulder replacement is now recognized as a reliable and effective therapeutic option for the treatment of various degenerative joint conditions.
- Trial name
- SubPostEOS (NCT07819149)
- Testing
- biplanar fluoroscopy EOS
- Where
- France
- Volunteers
- 92 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Primary Reverse Total Shoulder Arthroplasty
Does Undergoing a Prehabilitation Protocol Aimed at Optimizing Scapulothoracic Mobility and Strengthening Improve Internal Rotation After Reverse Shoulder Arthroplasty?
Difficulty with internal rotation (IR) after reverse shoulder arthroplasty (RSA) is common. Current rehabilitation protocols may not optimize IR.
- Trial name
- NCT07145957
- Testing
- Prehabilitation
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- University of Florida
Shoulder Osteoarthritis
Fixed Inclination Humeral Cut
The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a…
- Trial name
- NCT03922763
- Testing
- Anatomical cut, Cutting guide
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Rothman Institute Orthopaedics
Total Shoulder Arthroplasty
Analgesia After Total Shoulder Arthroplasty
The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total…
- Trial name
- NCT01782872
- Testing
- Interscalene Block (ISB) - 0.375% Ropivacaine + additives, Interscalene Block (ISB) - 0.2% Ropivacaine + additives, Interscalene Block (ISB) - 0.1% Ropivacaine + additives
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Hospital for Special Surgery, New York
Osteoarthritis of the Shoulder
TITAN™ Reverse Shoulder System
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the…
- Trial name
- NCT02204228
- Testing
- TITAN™ Reverse Shoulder System (TRS)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 151 people
- Sponsor
- Smith & Nephew, Inc.
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
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
Anatomic Total Shoulder Arthroplasty
Comparison of Glenoid Component Position Using Intelligent Reusable Instrument (IRI) vs Standard Surgical Instruments
The proposed clinical study will enroll patients indicated for standard of care anatomic total shoulder arthroplasty. They will receive all pre operative testing, intra-operative care including all implants and post operative…
- Trial name
- IRI (NCT01801241)
- Testing
- Anatomic TSA using IRI Instrumentation, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- The Cleveland Clinic
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
Pain
Liposomal Bupivacaine in Total Shoulder Arthroplasty
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible.
- Trial name
- EXP-TSA (NCT02570022)
- Testing
- Liposomal bupivacaine, Inter-scalene nerve block, Ropivacaine
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Henry Ford Health System
Shoulder Disease, Rotator Cuff Tear Arthropathy
Sling vs No Sling After Reverse Total Shoulder Arthroplasty
This study involves patients who will be undergoing a reverse total shoulder replacement at Duke University. 100 eligible will be randomly assigned into one of two groups, a sling or no sling group.
- Conditions
- Shoulder Disease, Rotator Cuff Tear Arthropathy, Shoulder Osteoarthritis
- Trial name
- NCT06092996
- Testing
- Time of Sling Use
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Duke University
Shoulder Arthroplasty, Total Shoulder Arthroplasty
A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic…
- Trial name
- NCT07812324
- Testing
- Mirror Anatomic Total Shoulder Prosthesis, Medacta Anatomic Shoulder
- Where
- 12 sites in United States
- Volunteers
- 286 people
- Sponsor
- Medacta USA
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
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