Clinical trials: Prostheses, open to volunteers
Peripheral Neuropathy
A Mixed-Methods Exploratory Pilot Study of the Investigational MYNERVA Leia Sensory Prosthesis in U.S. Adults With Peripheral Neuropathy
This is a US-specific pilot study to evaluate the short- and long-term effects of the investigational MYNERVA Leia Sensory Prosthesis on gait, neuropathic symptoms and quality of life in US adults with peripheral neuropathy, and…
- Trial name
- MYN-L001-002 (NCT07840157)
- Testing
- Leia Sensory Prosthesis
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Mynerva Inc.
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.
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
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
Lower Limb Amputation Above Knee (Injury)
Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.
New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life.
- Trial name
- INCREMENT (NCT06635655)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Proteor Group
Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Revision 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™ Revision Hip Prosthesis System in adult participants…
- Conditions
- Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint, Prostheses-related Infections, Joint Instability
- Trial name
- NCT07653295
- Testing
- Tıpmed™ Revision Hip Prosthesis System
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 35 people
- Sponsor
- TIPMED Medical Device Manufacturing Ltd. Co.
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.
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
Post-Meniscectomy Pain Syndrome
Early Artificial Lateral Prosthesis
The device subject to this clinical investigation has been developed for treating patients with a history of partial or total meniscectomy, who suffer from symptomatic unicompartmental pain in the meniscus-deficient knee: the…
- Trial name
- EARTH (NCT06705985)
- Testing
- Implantation of lateral meniscus prosthesis
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- ATRO Medical B.V.
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.
Osteoarthritis Thumb, Thumb Carpometacarpal Joint Osteoarthritis
TOUCH® CMC 1 New Enrollment US Study
The purpose of this study is to meet a PMA (P240020) condition of approval of the TOUCH® CMC 1 Prosthesis to evaluate the effectiveness and safety of the prosthesis in the United States (US) population.
- Trial name
- PAS002 (NCT07405983)
- Testing
- TOUCH® CMC 1 Prosthesis
- Where
- 4 sites in United States
- Volunteers
- 163 people
- Sponsor
- Keri Medical SA
Peripheral Neuropathy
Randomized, Sham-Controlled Investigation of the Leia Sensory Prosthesis in Individuals With Peripheral Neuropathy
This study will evaluate a wearable device intended to support balance and gait in adults with peripheral neuropathy. Participants will use the device for a defined period, and outcomes related to safety, usability, and…
- Trial name
- MYN-L001-001 (NCT07236515)
- Testing
- Active wearable device
- Where
- 3 sites in Switzerland
- Volunteers
- 80 people
- Sponsor
- MYNERVA AG
Complication, Prosthesis Durability
SEBBIN Round, Anatomical and Biconvex Gluteal Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled gluteal implants, included in the technical file of the device.
- Trial name
- NCT05062733
- Where
- 2 sites in Italy, Netherlands
- Volunteers
- 60 people
- Sponsor
- Groupe SEBBIN
Amputation of Lower Limb, Prosthesis
LIMBER UniLeg: Rapid, On-demand, and Scaled-up Manufacturing of Customized Transtibial Prosthetic Legs for Amputees
The LIMBER UniLeg, a 3D printed single-piece transtibial prosthetic limb, is sufficiently equivalent to traditional passive prosthetic limbs (no motors or sensors), while reducing the cost and time of manufacturing and enabling…
- Conditions
- Amputation of Lower Limb, Prosthesis, Non-inferiority Trial of Prothesis
- Trial name
- NCT06648798
- Testing
- Limber Limb
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- LIMBER Prosthetics & Orthotics Inc
Arthroplasty, Replacement
ORIGIN® vs. VANGUARD® PS Observational Study
The study objective is to assess patient satisfaction after the surgery with a patient match CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of…
- Conditions
- Arthroplasty, Replacement, Knee
- Trial name
- NCT04728542
- Testing
- ORIGIN PS System, VANGUARD PS System
- Where
- Germany
- Volunteers
- 140 people
- Sponsor
- Symbios Orthopedie SA
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
Amputation
Clinical Feasibility of the IMES Transradial Prosthesis
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
- Trial name
- NCT04936789
- Testing
- IMES
- Where
- United Kingdom
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
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
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
Complication, Prosthesis Durability
SEBBIN Silicone Gel-filled Testicular Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device.
- Trial name
- NCT04968470
- Where
- 2 sites in Belgium, France
- Volunteers
- 100 people
- Sponsor
- Groupe SEBBIN