Clinical trials: Arthroplasty, Replacement, Shoulder
Shoulder Arthroplasty
Shoulder Innovations Clinical Data Registry
The goal of this multi-center observational study is to collect long-term clinical outcome information for anatomic and reverse total shoulder arthroplasty (shoulder replacement).
- Trial name
- SICDR (NCT06754150)
- Where
- 10 sites in United States
- Volunteers
- 2,500 people
- Sponsor
- Shoulder Innovations
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
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
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
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
Pain
Efficacy, Safety, and Pharmacokinetics of Brachial Plexus Block With EXPAREL in Shoulder Surgery
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study in 155 adult subjects undergoing primary unilateral total shoulder arthroplasty or rotator cuff repair with general anesthesia
- Trial name
- NCT02713230
- Testing
- bupivacaine liposome injectable suspension
- Where
- 20 sites in United States, Belgium and 1 more
- Volunteers
- 156 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Arthroplasty, Replacement, Shoulder, Glenoid Cavity
Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
This post-market follow-up study investigates improvement in clinical and radiological outcome after reversed total shoulder arthroplasty with the patient-specific Glenius Glenoid Reconstruction system
- Conditions
- Arthroplasty, Replacement, Shoulder, Glenoid Cavity, Osteoarthritis of the Shoulder
- Trial name
- NCT03806881
- Testing
- reversed glenoid prothesis
- Where
- 4 sites in Belgium, Netherlands
- Volunteers
- 24 people
- Sponsor
- Materialise
Cuff Tear Arthropathy, Primary Osteoarthritis
Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are…
- Conditions
- Cuff Tear Arthropathy, Primary Osteoarthritis, Secondary Osteoarthritis, Shoulder Osteoarthritis
- Trial name
- NCT05128500
- Testing
- Total Shoulder Arthroplasty with Permedica's MIRAI
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 76 people
- Sponsor
- Permedica spa
Osteoarthritis Shoulder, Rotator Cuff Tears
DenCT Shoulder Bone Quality Evaluation
The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.
- Trial name
- NCT06032416
- Testing
- Preoperative CT Scan
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Joint Disease
Comprehensive Shoulder System Nano IDE
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).
- Trial name
- Nano (NCT01936259)
- Testing
- Mini Stem, Nano
- Where
- 12 sites in United States
- Volunteers
- 258 people
- Sponsor
- Zimmer Biomet
Shoulder Arthritis, Shoulder Osteoarthritis
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis
- Trial name
- NCT05314387
- Testing
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Volunteers
- 100 people
- Sponsor
- Limacorporate S.p.a
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
Shoulder Fractures, Shoulder Arthritis Osteoarthritis
Zimmer Biomet Shoulder Arthroplasty PMCF Study
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in…
- Conditions
- Shoulder Fractures, Shoulder Arthritis Osteoarthritis, Shoulder Injury, Shoulder Pain
- Trial name
- NCT06920459
- Testing
- Alliance™ Glenoid
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Primary Generalized (Osteo)Arthritis, Post-traumatic Arthrosis of Other Joints, Upper Arm
Simpliciti IDE Trial; Replacing the Humeral Head in Total Shoulder Arthroplasty
The purpose of this study is to demonstrate safety and efficacy of the Simpliciti Shoulder System in total shoulder arthroplasty.
- Trial name
- NCT01390038
- Testing
- Simpliciti™ Shoulder System
- Where
- 14 sites in United States
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- Stryker Trauma and Extremities
Shoulder Arthroplasty
Total Shoulder Arthroplasty Multi-Center Registry
The objective of the study is a multi-center prospective registry to collect clinical outcomes of anatomic and reverse total shoulder arthroplasty.
- Trial name
- NCT03511586
- Where
- 27 sites in United States, Germany and 2 more
- Volunteers
- 2,500 people
- Sponsor
- Arthrex, Inc.
Arthroplasty, Replacement
SMR Stemless Reverse vs SMR Reverse Shoulder System
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
- Trial name
- NCT04697004
- Testing
- Investigational Arm: SMR Stemless Reverse, Control Arm: SMR Reverse Shoulder System
- Where
- 13 sites in United States
- Volunteers
- 200 people
- Sponsor
- Limacorporate S.p.a
Reverse Shoulder Replacement
Tornier Blueprint Planning Software in Patients Receiving Reverse Shoulder Arthroplasty
Compare sizing determined in pre-operative planning of reverse shoulder arthroplasty to operative implant size selected.
- Trial name
- NCT04474665
- Testing
- Reverse shoulder arthroplasty utilizing Blueprint Software
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Spine Institute of Louisiana Foundation
Osteo Arthritis Shoulders, Traumatic Arthritis
Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement
A post market, prospective, non-randomized, multi-center, open-label, clinical study using survivorship as the reference performance goal to study the safety and efficacy of the Titan Modular Shoulder System 2.5 when used for…
- Conditions
- Osteo Arthritis Shoulders, Traumatic Arthritis, Rheumatoid Arthritis
- Trial name
- NCT03250767
- Testing
- Integra Titan Modular Shoulder System 2.5
- Where
- 7 sites in United States
- Volunteers
- 58 people
- Sponsor
- Smith & Nephew, Inc.
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