Clinical trials: SHOULDER ARTHROPLASTY
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
Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region
Aequalis Resurfacing Head Study
Aequalis® Resurfacing Head implant is a range of shoulder arthroplasty device available for the treatment of various shoulder pathologies. It received CE Mark in June 2007.
- Conditions
- Localized, Primary Osteoarthritis, Post-traumatic Arthrosis of Other Joints, Shoulder Region, Avascular Necrosis of the Head of Humerus
- Trial name
- NCT02444299
- Testing
- Shoulder hemi-arthroplasty
- Volunteers
- 100 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
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Comprehensive Reverse Shoulder Data Collection
This study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. The primary objective of this study is to evaluate improvement of pain score at one year for the Biomet Comprehensive Reverse…
- Conditions
- Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff, Osteoarthritis of the Shoulder, Rheumatoid Arthritis Without Humeral Metaphyseal Defects
- Trial name
- NCT03404778
- Testing
- Biomet Comprehensive Reverse Shoulder
- Where
- 4 sites in United States
- Volunteers
- 175 people
- Sponsor
- Zimmer Biomet
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.
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
Rotator Cuff Arthropathy, Failed Total Shoulder
Reverse Shoulder Prosthesis Study
The objective of this clinical study is to evaluate the safety and efficacy of the Encore Reverse Shoulder Prosthesis (RSP). The clinical results of the RSP will be compared to clinical results published in literature for rotator…
- Conditions
- Rotator Cuff Arthropathy, Failed Total Shoulder, Failed Hemi-arthroplasty
- Trial name
- RSP (NCT00764504)
- Testing
- Reverse Shoulder Prosthesis
- Where
- 25 sites in United States
- Volunteers
- 516 people
- Sponsor
- Encore Medical, L.P.
Rotator Cuff Tears
Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®
Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.
- Trial name
- NCT05333211
- Testing
- Ortho-R/PRP
- Where
- 9 sites in United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- ChitogenX Inc
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
Osteoarthritis, Post-traumatic; Arthrosis
Long Term Sidus PMCF
The objectives of this study are to assess the safety and performance of the Sidus Stem-Free Shoulder Arthroplasty System in unilateral primary total shoulder arthroplasty.
- Trial name
- NCT04063943
- Testing
- Sidus Stem-Free Shoulder
- Where
- 7 sites in United States, Canada
- Sponsor
- Zimmer Biomet
Tendon Injuries- Subscapularis
Embody Post-Market Clinical Follow-Up Study
A multi-center, prospective post-market clinical follow-up study: subscapularis repair augmented with Tapestry Biointegrative Implant after shoulder arthroplasty.
- Trial name
- RAISE (NCT05735119)
- Testing
- Tapestry Biointegrative Implant
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively.
- Conditions
- Glenohumeral Osteoarthritis, Proximal Humerus Fracture, Rotator Cuff Arthropathy, Rheumatoid Arthritis
- Trial name
- NCT07678034
- Testing
- Tipmed™ Reverse Shoulder Prosthesis System, Tipmed™ Shoulder Prosthesis System (Hemiarthroplasty Configuration)
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 54 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
Primary Osteoarthritis, Secondary Osteoarthritis
Clinical and Radiological Outcomes of Medacta Shoulder System
This is a post-marketing surveillance on Medacta Shoulder System
- Conditions
- Primary Osteoarthritis, Secondary Osteoarthritis, Rotator Cuff Tear Arthropathy, Rheumatoid Arthritis Shoulder
- Trial name
- NCT03547947
- Testing
- Medacta Shoulder System
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Medacta International SA
Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder
FX Shoulder Solutions Retrospective / Prospective Clinical Study
Subjects implanted with the shoulder replacement medical devices manufactured by FX Shoulder Solutions and distributed by FX Shoulder Solutions.
- Conditions
- Rotator Cuff Syndrome of Shoulder and Allied Disorders, Osteoarthritis Shoulder, Fracture, Shoulder
- Trial name
- NCT06077942
- Testing
- FX Artificial Shoulder Prosthesis
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- FX Shoulder Solutions
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
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
Fracture
Anatomical Shoulder™ Fracture PMCF Study
The purpose of this study is to obtain outcomes data on the Anatomical Shoulder Fracture System by analysis of standard scoring systems and radiographs.
- Trial name
- NCT02465398
- Testing
- Fracture Shoulder Arthroplasty
- Where
- 3 sites in Germany, Switzerland and 1 more
- Volunteers
- 52 people
- Sponsor
- Zimmer Biomet
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