Clinical trials: SHOULDER ARTHROPLASTY
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
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
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 Disease, Shoulder Fractures
Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term
This study takes place in the framework of the Post-Market Clinical Follow-up of the FX Solutions Shoulder System. The goal of this PMCF study is to collect clinical data in order to confirm the safety and the performance at a…
- Conditions
- Shoulder Disease, Shoulder Fractures, Shoulder Arthroplasty for Revision of Previous Treatment
- Trial name
- NCT05284357
- Testing
- Shoulder Arthroplasty Surgery with HUMELOCK I & II® Anatomic Shoulder System, Shoulder Arthroplasty Surgery with HUMELOCK II® Reversible System, Shoulder Arthroplasty Surgery with HUMELOCK Reversed® Shoulder System
- Where
- 20 sites in France, Monaco
- Volunteers
- 416 people
- Sponsor
- FX Solutions
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.
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Osteoarthritis Shoulder, Fracture
Multi Centre Study on TESS V2 Shoulder System
This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.
- Conditions
- Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis
- Trial name
- NCT03431857
- Testing
- TESS V2
- Where
- 2 sites in Belgium, France
- Volunteers
- 106 people
- Sponsor
- Zimmer Biomet
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
Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder
Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
It is a non-randomized, consecutive enrollment, 10-year follow-up study of patients who are treated with the Ascension® HRA. Its purpose is to measure and document the outcomes associated with implanting the Ascension HRA…
- Conditions
- Shoulder Arthritis Osteoarthritis, Rheumatoid Arthritis Shoulder, Acquired Deformity of Head, Post-traumatic Arthrosis of Other Joints, Shoulder Region
- Trial name
- NCT02029469
- Testing
- Ascension HRA device
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Ascension Orthopedics, Inc.
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
Rotator Cuff Injuries, Shoulder Pain
ASHCOM Shoulder System and Its Related Instruments
The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy; Traumatic, Arthroplasty Complications
- Trial name
- NCT04258605
- Testing
- ASHCOM Shoulder System
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- Zimmer Biomet
Shoulder Osteoarthritis, Shoulder Arthritis
AETOS Shoulder System
The goal of this study is to confirm the safety and performance of the AETOS Shoulder System for USA adoption. This is a prospective, open, adaptive, non-comparative, multi-centre investigation enrolling a maximum of 220 subjects…
- Trial name
- NCT06319911
- Testing
- AETOS
- Where
- 5 sites in United States
- Volunteers
- 220 people
- Sponsor
- Smith & Nephew, Inc.
Shoulder Arthroplasty and Fracture Repair
Tornier Shoulder Outcomes Study to Examine Safety and Functional Outcomes in Shoulder Arthroplasty and Fracture Patients
The Tornier Shoulder Outcomes Study is designed to collect safety and efficacy data on designated commercially available Tornier Shoulder repair products.
- Trial name
- NCT02047955
- Testing
- Shoulder Arthroplasty
- Where
- 15 sites in United States
- Volunteers
- 7,500 people
- Sponsor
- Stryker Trauma and Extremities
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion TSA System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03858517
- Testing
- ReUnion TSA System
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- Stryker Trauma and Extremities
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