Clinical trials: Prosthesis, open to volunteers
Primary Osteoarthritis, Cartilage Degeneration
DEXA Bone Density Analysis of the CoreHip® Prosthesis System
The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density (Gruen Zones 3 and 4) within 24 months postoperative in patients treated with CoreHip® primary…
- Conditions
- Primary Osteoarthritis, Cartilage Degeneration, Osteoarthritis, Hip, Inflammatory Arthritis
- Trial name
- CODEX (NCT06632301)
- Testing
- Primary hip replacement with cementless stem
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Aesculap AG
Amputation, Prosthesis User
Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators
The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses.
- Conditions
- Amputation, Prosthesis User, Amputation; Traumatic, Leg: Thigh, Between Hip and Knee, Limb; Absence, Congenital, Lower
- Trial name
- NCT06937242
- Testing
- Ottobock C-Leg 4 Microprocessor Knee, Ottobock Kenevo
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Hanger Institute for Clinical Research and Education, LLC
Hip Surgery
Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.
The objective of this observatory is to generate additional real life clinical data in accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study carried out following the European Conformity (CE)…
- Trial name
- HipFHOrtho (NCT05966220)
- Testing
- Hip surgery with FH Ortho devices
- Where
- 5 sites in France
- Volunteers
- 800 people
- Sponsor
- FH ORTHO
Upper Limb Amputation Above Elbow, Upper Limb Amputation Below Elbow
Long-Term Stability of the Glide Control Strategy
This research is intended to test whether the prescription of the Glide prosthesis control system reduces the burden of use for both patients and their clinical care team as compared to use of Pattern Recognition-based advanced…
- Trial name
- NCT07222085
- Testing
- Glide Control System, Pattern Recognition System
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- Infinite Biomedical Technologies
Rheumatoid Arthritis, Arthritis of Ankle
Vantage Mobile Bearing Total Ankle System Post Market Clinical Follow-up (Outside US)
The objectives of this study are to evaluate the performance and safety of the Vantage Mobile-Bearing Total Angle System. This study will follow subjects for a period of up to 10 years post-surgery.
- Conditions
- Rheumatoid Arthritis, Arthritis of Ankle, Failure, Prosthesis
- Trial name
- NCT05691868
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 400 people
- Sponsor
- Exactech
Prosthesis User, Lower Limb Amputation Below Knee (Injury)
Caesar Foot Take-Home Validation Testing
The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment.
- Trial name
- NCT07075198
- Testing
- Caesar Foot
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Liberating Technologies, Inc.
Age - Related Macular Degeneration (AMD)
International Study of the SING IMT™ Prosthesis in Pseudophakic patiEnts With Stable Moderate to Profound Bilateral Central vIsion Impairment Due to adVancEd AMD / PERSPECTIVE Study
This study aims to expand the CE mark IFU of the SING IMT™ to pseudophakic (patients with an intraocular lents) patients with late stage of AMD (Age-Related Macular Degeneration) and bilateral central vision impairment.
- Trial name
- PERSPECTIVE (NCT07164378)
- Testing
- Lens-Exchange, Add-on
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 44 people
- Sponsor
- VisionCare, Inc.
Total Knee Arthroplasty
Performance and Safety Evaluation of the FHK®-CK Knee Prosthesis
The life expectancy worldwide is increasing and leading to an increase of knee arthroplasty. Also, as millions of people around the world are currently living with a Total Knee Arthroplasty (TKA), the need for revision surgery…
- Trial name
- FHK-CK (NCT06124482)
- Testing
- Total Knee arthroplasty
- Where
- 7 sites in France
- Volunteers
- 92 people
- Sponsor
- FH ORTHO
Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater
Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity
The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN).
- Conditions
- Peripheral Neuropathy With Type 2 Diabetes, Peripheral Neuropathy Grade 2 or Greater, Balance, Balance Impairment, Gait Disorders, Fatigue
- Trial name
- NCT07554443
- Testing
- External, lower limb sensory prosthesis
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- RxFunction Inc.
Total Hip Replacement
Post-Market Observational Study of the HARMONY® Evolution Implants and Instruments
The purpose of this study is to evaluate the safety and performance of the HARMONY® Evolution implants in a series of operated subjects treated in THR.
- Trial name
- NCT06628336
- Testing
- HARMONY EVOLUTION
- Where
- 5 sites in France
- Volunteers
- 264 people
- Sponsor
- Symbios Orthopedie SA
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
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
Osteoarthrosis of Knee
Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis
This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine…
- Trial name
- NCT04858347
- Testing
- Total knee replacement
- Where
- Colombia
- Volunteers
- 350 people
- Sponsor
- Waldemar Link GmbH & Co. KG
Revision of a Shoulder Prosthesis
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Anatomical Shoulder Bipolar System
The study is a monocentric, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study.
- Trial name
- NCT05358574
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Zimmer Biomet
Prosthesis and Implants
Transdermal Compress IDE Study
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
- Trial name
- NCT06134167
- Testing
- Transdermal Compress Device
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Balmoral Medical company
Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation
Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control
The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses.
- Conditions
- Upper Limb Amputation Below Elbow (Injury), Wrist Disarticulation, Transradial Amputation
- Trial name
- CYBORG (NCT07325708)
- Testing
- Phantom X multielectrode EMG sensor array implant for upper limb prosthesis control
- Where
- 2 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Phantom Neuro Inc.
Total Hip Arthroplasty (THA), Hemiarthroplasty
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Primary Hip Prosthesis System
This is a multicenter, prospective, observational, post-market clinical follow-up (PMCF) study designed to evaluate the safety and clinical performance of the Tipmed™ Primary Hip Prosthesis System in adult subjects undergoing…
- Conditions
- Total Hip Arthroplasty (THA), Hemiarthroplasty, Osteoarthritis (OA) of the Hip, Femoral Neck Fractures
- Trial name
- NCT07651735
- Testing
- Tipmed™ Primary Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 101 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
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.
Total Hip Arthroplasty, Survival, Prosthesis
Multicenter Mpact DM France
The primary objective of the study is to evaluate the 10-year performance of the MPACT DM cup in the treatment of patients requiring total hip arthroplasty.
- Trial name
- NCT05818891
- Where
- France
- Volunteers
- 600 people
- Sponsor
- Medacta International SA
Humeral Fracture, Proximal, Glenohumeral Osteoarthritis
RETRO-PROSPECTIVE POSTMARKET CLINICAL STUDY FOR FX SHOULDER SOLUTIONS SHOULDER SYSTEMS
This study takes place in the framework of the PostMarket Clinical Follow-up plan of the Shoulder Systems commercialized by FX SHOULDER SOLUTIONS. The included cases will be followed for 10 years after index surgery.
- Conditions
- Humeral Fracture, Proximal, Glenohumeral Osteoarthritis, Avascular Necrosis of the Head of Humerus, Rotator Cuff Tear
- Trial name
- NCT07558590
- Testing
- Shoulder arthroplasty
- Where
- 22 sites in France, Monaco
- Volunteers
- 1,004 people
- Sponsor
- FX Solutions