Clinical trials: SHOULDER ARTHROPLASTY
Osteoarthritis Shoulder, Rheumatoid Arthritis
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
The objective of this study is to collect and evaluate long-term clinical outcomes data in order to better understand the safety and performance of the Equinoxe Humeral Reconstruction Prosthesis in shoulder arthroplasty over…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Oncology
- Trial name
- HRP (NCT05615246)
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Exactech
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System FR
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT05926622
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
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
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
Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus
Catalyst CSR Shoulder System for Semi or Total Shoulder Arthroplasty
Evaluation of the performance and safety of the Catalyst CSR Shoulder System with clinical and radiographic results at multiple time points through 24 months postoperatively This study will be a prospective multi-center study…
- Conditions
- Osteoarthritis Shoulder, Avascular Necrosis of the Head of Humerus, Rheumatoid Arthritis Shoulder
- Trial name
- NCT04968405
- Testing
- Catalyst CSR Total Shoulder System
- Where
- 3 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Catalyst OrthoScience
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
Arthroplasty Complications, Osteo Arthritis Shoulders
Comprehensive SRS Regenerex Tissue Attachment
The objective of this retrospective and prospective consecutive series data collection is to confirm safety, performance, and clinical benefits of the Comprehensive SRS Regenerex Tissue Attachment Augments when used for limb…
- Trial name
- NCT06615739
- Testing
- Regenerex Tissue Attachment Augments
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Zimmer Biomet
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
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
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis
- Trial name
- NCT04003272
- Testing
- Comprehensive Reverse Versa-Dial Titanium Glenosphere
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Zimmer Biomet
Primary Osteoarthritis, Secondary Osteoarthritis
SMR Stemless Shoulder Arthroplasty Clinical Study
Shoulder arthroplasty is a reliable procedure for the treatment of severe shoulder joint diseases to relieve pain and restore shoulder function.
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Post-traumatic; Arthrosis, Rheumatoid Arthritis
- Trial name
- NCT02679352
- Testing
- SMR Stemless
- Where
- 4 sites in Germany, Netherlands and 1 more
- Volunteers
- 78 people
- Sponsor
- Limacorporate S.p.a
Avascular Necrosis, Revision Surgery
Anatomical Shoulder Domelock System Study
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event…
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid
- Trial name
- NCT03312465
- Testing
- AS Domelock System
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 73 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
Osteoarthritis, Posttraumatic Arthrosis
Sidus Stem-Free Shoulder IDE Study
The purpose of this study is to determine if Sidus stem-free shoulder system is safe and effective when used in total shoulder replacement.
- Conditions
- Osteoarthritis, Posttraumatic Arthrosis, Rheumatoid Arthritis
- Trial name
- NCT01878253
- Testing
- Sidus Stem-Free Total Shoulder Arthroplasty System
- Where
- 11 sites in United States, Canada
- Volunteers
- 95 people
- Sponsor
- Zimmer Biomet
Rotator Cuff Injuries, Shoulder Pain
Anaverse™ Glenoid System and Its Instrumentation
The objectives of this study are to confirm safety, performance and clinical benefits of the Anaverse™ Glenoid System and its instrumentation by analysis of standard scoring systems, radiographs and adverse event records.
- Conditions
- Rotator Cuff Injuries, Shoulder Pain, Arthropathy, Arthroplasty Complications
- Trial name
- NCT05215600
- Testing
- Anaverse Shoulder System
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Arthritis
S.E.S Shoulder Arthroplasty Data Collection
This observational study intends to collect efficacy and safety data on S.E.S shoulder system
- Trial name
- NCT00754416
- Where
- 12 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
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
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
The INSPYRE implant is a new range of shoulder hemi-arthroplasty device. It consists of a Pyrocarbon spherical interpositional implant and is indicated in primary surgery to relieve severe pain or significant disability caused by…
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02424760
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 67 people
- Sponsor
- Stryker Trauma and Extremities
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
Osteoarthritis, Rheumatoid Arthritis
Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480453
- Testing
- Trabecular Metal Humeral Stem
- Where
- 3 sites in United States
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet