Clinical trials: Shoulder Arthroplasty
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, 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
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
Arthroplasty, Replacement, Shoulder
S-33 SMR Shoulder HP Reverse Glenosphere
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision…
- Trial name
- NCT05339815
- Testing
- SMR shoulder arthroplasty
- Where
- United Kingdom
- Volunteers
- 205 people
- Sponsor
- Limacorporate S.p.a
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03726554
- Testing
- Comprehensive Reverse Porous Augmented Glenoid, Comprehensive Mini Humeral Tray
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Zimmer Biomet
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 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.
Shoulder Osteoarthritis
Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
The aim of this observationnal post-marketing study is to provide additional information on the safety and effectiveness of Simpliciti™ system at 24 months post-shoulder arthroplasty , in usual surgical practice.
- Trial name
- NCT02452957
- Where
- Germany
- Sponsor
- Stryker Trauma and Extremities
Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis
Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty.
- Conditions
- Non-inflammatory Degenerative Joint Disease (NIDJD), Avascular Necrosis, Osteoarthritis, Inflammatory Joint Disease (IJD)
- Trial name
- NCT01700543
- Testing
- Shoulder Arthroplasty
- Where
- 8 sites in Austria, France and 3 more
- Volunteers
- 152 people
- Sponsor
- Zimmer Biomet
Arthroplasty
Arthroplasty Cements Outcomes - A Post-market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all…
- Trial name
- NCT06354543
- Testing
- Cemented joint arthroplasty
- Where
- 10 sites in France, Italy
- Volunteers
- 1,050 people
- Sponsor
- Teknimed
Rotator Cuff Tears of the Shoulder
Integrity Implant System Post Market Clinical Follow-Up Study
The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff…
- Trial name
- NCT06741527
- Testing
- Integrity Implant System
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Anika Therapeutics, Inc.
Joint Replacement, Arthropathy
The restor3d Outcomes Registry
The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic…
- Trial name
- NCT07563803
- Testing
- Patient-Specific Orthopedic Implant
- Where
- United States
- Volunteers
- 2,250 people
- Sponsor
- Restor3D
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
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
Rotator Cuff
Safety of Treatment of Shoulder Repair
This study evaluates the safety of the HEALICOIL Knotless Suture Anchors in patients requiring a repair of the rotator cuff tendon repair
- Trial name
- HEALICOIL_KNTL (NCT04552119)
- Testing
- HEALICOIL Knotless PEEK, HEALICOIL Knotless REGENESORB
- Where
- 5 sites in United States
- Volunteers
- 138 people
- Sponsor
- Smith & Nephew, Inc.
Shoulder Arthroplasty
A Post-Market Clinical Evaluation of the ReUnion Reverse Shoulder Arthroplasty (RSA) System
This investigation is a prospective, multicenter clinical investigation. It is anticipated that a total of eighty (80) subjects will be enrolled at approximately 4-7 sites.
- Trial name
- NCT03880955
- Testing
- ReUnion RSA System
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- Stryker Trauma and Extremities
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
Osteoarthritis Shoulder, Rheumatoid Arthritis
TESS V3 Modular Total Shoulder System PMCF
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis
- Trial name
- NCT05002959
- Testing
- Anatomic TESS V3, Reverse TESS V3
- Where
- 2 sites in France
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet
Arthroscopy
A Clinical Study to Evaluate the Safety and Efficacy of Q-Fix Trial in Chinese Patients
Protocol synopsis Title of Study: A Prospective, Randomized, Multi-Center Clinical Study to Evaluate the Safety and Efficacy of Q-Fix All-Suture Anchor in Arthroscopic Repair of Shoulder Soft Tissue in Chinese Patients Study…
- Trial name
- Q-Fix (NCT03765515)
- Testing
- Twinfix Ti, Q-Fix
- Where
- 4 sites in China
- Volunteers
- 128 people
- Sponsor
- Smith & Nephew, Inc.