Clinical trials: Total Shoulder Arthroplasty
Osteoarthritis, Avascular Necrosis
A Clinical Investigation of the Comprehensive®, BioModular®, and Bi-Angular® Shoulder Systems
The purpose of this prospective clinical data collection is to document the performance and clinical outcomes of Biomet Humeral Stems
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Humeral Fractures
- Trial name
- NCT00699270
- Sponsor
- Biomet Orthopedics, LLC
Shoulder Fractures, Shoulder Arthritis
Zimmer Biomet Shoulder Arthroplasty PMCF
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty.
- Conditions
- Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity
- Trial name
- NCT04984291
- Testing
- Alliance Glenoid, Identity Stem
- Where
- 17 sites in United States, Japan and 1 more
- Volunteers
- 584 people
- Sponsor
- Zimmer Biomet
Shoulder Arthroplasty, Shoulder Joint Disease
Radiographic and Clinical Outcomes After Short-Stem Reverse Shoulder Arthroplasty
Reverse total shoulder arthroplasty (RTSA) has become increasingly common in recent years due to expanding indications and improved surgical techniques.
- Conditions
- Shoulder Arthroplasty, Shoulder Joint Disease, Reverse Shoulder Prosthesis
- Trial name
- STEP2yrs (NCT07651215)
- Where
- Austria
- Volunteers
- 50 people
- Sponsor
- Krankenhaus Barmherzige Schwestern Linz
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
Analgesia
A Multi-surgery Assessment of ZYNRELEF (HTX-011), AMAZE. Master Protocol HTX-011-401.
This is a Phase 4, randomized, blinded, active-controlled, multicohort study to evaluate HTX-011 compared with bupivacaine HCl in subjects undergoing different surgical procedures.
- Trial name
- NCT05109312
- Testing
- Bupivacaine Hydrochloride, HTX-011, Luer lock applicator
- Where
- 7 sites in United States
- Volunteers
- 90 people
- Sponsor
- Heron Therapeutics
Shoulder Arthropathy Associated With Other Conditions
Reverse Shoulder Replacement: Formal vs. Home Physiotherapy
The purpose of this study is to compare range of motion between a structured home exercise program to supervised physiotherapy post-operatively after Reverse Total Shoulder Replacement is performed for rotator cuff tear…
- Trial name
- NCT03430167
- Testing
- home therapy, formal therapy
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Washington University School of Medicine
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 Arthritis, Shoulder Arthropathy Associated With Other Conditions
Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond
The objective is to compare two types of wound closure after total shoulder arthroplasty to determine which closure is faster, and subsequently if there are different outcomes between the two types of closures.
- Trial name
- NCT03899753
- Testing
- 2-Octyl Cyanoacrylate and Mesh, 2-Octyl Cyanoacrylate
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
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
Shoulder Arthritis
A Study Comparing Shoulder Replacement Techniques For Patients With Shoulder Arthritis And An Intact Rotator Cuff
The purpose of this study is to determine if patients undergoing anatomic total shoulder arthroplasty (aTSA) will have improved patient reported outcome scores at 1 year compared to those undergoing reverse total shoulder…
- Trial name
- SOAR (NCT07584356)
- Testing
- aTSA, rTSA
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Mayo Clinic
Osteoarthritis, Arthropathy
Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements.
- Conditions
- Osteoarthritis, Arthropathy, Shoulder Pain, Closed Fracture Proximal Humerus, Four Part
- Trial name
- NCT02762071
- Testing
- Liposomal bupivacaine, Interscalene Nerve Block
- Where
- 2 sites in United States
- Volunteers
- 108 people
- Sponsor
- Johns Hopkins University
Total Shoulder Arthroplasty, Shoulder Osteoarthritis
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia…
- Trial name
- NCT03969875
- Testing
- Interscalene catheter, Liposomal bupivacaine, Dexamethasone
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies.
- Conditions
- Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis, Post Traumatic Injury to Shoulder
- Trial name
- NCT00737087
- Testing
- Delta Xtend Reverse Total Shoulder
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 144 people
- Sponsor
- DePuy International
Pain
Exparel Interscalene vs Indwelling Catheter
The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).
- Trial name
- NCT03827213
- Testing
- Exparel, Indwelling Interscalene Catheter
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Montefiore Medical Center
Shoulder Joint Disease, Complications; Arthroplasty
Tranexamic Acid in Reverse Total Shoulder Arthroplasty
To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo…
- Conditions
- Shoulder Joint Disease, Complications; Arthroplasty, Intraoperative Complications, Blood Loss, Surgical
- Trial name
- TXA (NCT02043132)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Corewell Health East
Arthroplasty, Replacement
INHANCE Stemless Reverse Shoulder IDE
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Trial name
- NCT06323980
- Testing
- Reverse Total Shoulder
- Where
- 15 sites in United States
- Volunteers
- 168 people
- Sponsor
- DePuy Orthopaedics
Anatomic Total Shoulder Arthroplasty
Use of Real Time Instrumentation (RTI) in Total Shoulder Arthroplasty
Glenoid component loosening is the most common complication of total shoulder arthroplasty. Loosening is associated with malposition of the implant as well as the quality of the glenoid bone.
- Trial name
- RTI (NCT01905241)
- Testing
- Anatomic TSA using RTI, Anatomic Total Shoulder Arthroplasty
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Cleveland Clinic
Reverse Total Shoulder Arthroplasty
Reverse Total Shoulder Arthroplasty in Patients Who Exceeded Their Life-expectancy: a Retrospective Study
Reverse total shoulder arthroplasty (RTSA) has become an established treatment for cuff arthropathy, severe osteoarthritis and in certain fracture cases.
- Trial name
- NCT04807322
- Testing
- Reverse Total Shoulder Arthroplasty (RTSA)
- Where
- Switzerland
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Bürgerspital Solothurn
Arthroplasty, Replacement, Shoulder
Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty
The aim of the study is to evaluate if intravenous steroid supplementation can provide advantages over routine analgesia protocols in terms of post-operative symptoms (pain and nausea), length of hospital stay, shoulder range of…
- Trial name
- NCT04507412
- Testing
- dexamethasone
- Where
- Switzerland
- Volunteers
- 74 people
- Sponsor
- Christian Candrian