Clinical trials: Prostheses and Implants
Surgery
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they…
- Trial name
- CUSTOMBONE (NCT01824706)
- Testing
- craniectomy
- Where
- 18 sites in France
- Volunteers
- 110 people
- Sponsor
- Integra LifeSciences Corporation
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
Knee Injuries and Disorders
AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
- Trial name
- AIR2 (NCT05297175)
- Testing
- Trammpolin medial meniscus prosthesis
- Where
- 3 sites in Netherlands
- Volunteers
- 10 people
- Sponsor
- ATRO Medical B.V.
Osteoarthritis of Hip, Congenital Hip Dysplasia
Clinical and Radiographic Outcomes of the Corin Tri-Fit Total Hip Replacement
The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over…
- Conditions
- Osteoarthritis of Hip, Congenital Hip Dysplasia, Avascular Necrosis
- Trial name
- NCT02162186
- Where
- Canada
- Volunteers
- 37 people
- Sponsor
- Corin
Single Sided Deafness
Evaluation of Benefit for Treatment of Single Sided Deafness (SSD) Between Two Bone Conduction Prosthetic Devices; Osseointegrated Implant Versus Maxilla Anchored Removable Oral Appliance ("SoundBite")
The primary objective of this study is to compare the SoundBite™ Hearing System to surgically implanted BCD systems.
- Trial name
- NCT01933386
- Testing
- SoundBite
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Sonitus Medical Inc
Total Knee Arthroplasty, Knee Disease
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT04727060
- Testing
- patient with knee arthroplasty
- Where
- France
- Volunteers
- 2,146 people
- Sponsor
- Corin
Age Related Macular Degeneration
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
- Trial name
- NCT01361256
- Testing
- Telescope prosthesis, WA-NG Telescope Prothesis
- Where
- Israel
- Sponsor
- VisionCare, Inc.
Osteoarthritis, Hip, Rheumatoid Arthritis
Exception Cementless Hip Stem
This study is a multicenter, retrospective and prospective, non-controlled, non-randomized post market clinical follow-up study.
- Conditions
- Osteoarthritis, Hip, Rheumatoid Arthritis, Inflammatory Arthritis, Congenital Hip Dysplasia
- Trial name
- Exception (NCT04349046)
- Testing
- Total hip arthoplasty (THA)
- Where
- 6 sites in Belgium, France
- Volunteers
- 332 people
- Sponsor
- Zimmer Biomet
Degenerative Joint Disease of Hip, Osteoarthritis, Hip
Maxera Large Cups - Canada
This study is monocentric, retrospective and prospective, non-controlled, consecutive series Post-Market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Largest Zimmer® Maxera™ Cup…
- Conditions
- Degenerative Joint Disease of Hip, Osteoarthritis, Hip, Avascular Necrosis of Hip, Post-Traumatic Osteoarthritis of Hip
- Trial name
- Maxera Canada (NCT04348968)
- Testing
- Total hip arthroplasty
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Complication, Prosthesis Durability
SEBBIN INTEGRITY Round Implants
This study is part of the clinical evaluation of SEBBIN silicone gel-filled INTEGRITY implants, included in the technical file of the device.
- Trial name
- NCT05642390
- Testing
- Breast implant
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Groupe SEBBIN
Dental Implant, Dental Restoration
Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants "Kontact N"; and the effects of its nanostructured surface on the osseointegration and secondary stability…
- Conditions
- Dental Implant, Dental Restoration, Edentulous Alveolar Ridge, Implant-supported Fixed Prosthesis
- Trial name
- NCT03582657
- Testing
- dental implant (KONTACT N)
- Where
- France
- Volunteers
- 164 people
- Sponsor
- Biotech Dental
Missing Teeth, Prosthesis Survival
Evaluation of Single-unit Implant-supported Prostheses Survival Using CoCr Prosthetic Abutments: Prospective Observational Study
The aim of the study is to prospectively evaluate the survival of JJGC Cobalt-Chromium (CoCr) prosthetic abutments in single-unit implant-supported prostheses, to confirm the long-term safety and performance of the devices.
- Trial name
- NCT05649085
- Testing
- Cobalt-Chromium (CoCr) prosthetic abutments
- Where
- Brazil
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Neodent
Age Related Macular Degeneration
Study of WA-NG Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration
This is a pilot study to evaluate the safety of the Model WA-NG telescope prosthesis in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.
- Trial name
- NCT01731964
- Testing
- Telescope prosthesis, WA-NG Telescope Prothesis
- Where
- Israel
- Sponsor
- VisionCare, Inc.
Dentistry, Dental Implant
Performance and Safety Use of the Mono Block Implant "KONTACT MB"
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue…
- Conditions
- Dentistry, Dental Implant, Dental Restoration, Implant-supported Fixed Prosthesis
- Trial name
- NCT05016258
- Testing
- KONTACT MB
- Where
- France
- Volunteers
- 159 people
- Sponsor
- Biotech Dental
Hallux Rigidus, Hallux Limitus
Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
The great toe is vital for normal, pain free ambulation. Decreased function associated with osteoarthritis of the first matatarsal phalangeal joint (MTP I) often called Hallux Rigidis or Hallux Limitus leading to a painful great…
- Conditions
- Hallux Rigidus, Hallux Limitus, Hallux Valgus, Osteoarthritis
- Trial name
- NCT01284985
- Where
- 4 sites in Czechia, Netherlands and 2 more
- Volunteers
- 60 people
- Sponsor
- Integra LifeSciences Services
Retinal Degeneration, Inherited Retinal Dystrophy Primarily Involving Sensory Retina
Impact on Daily Life of Patients Using the Subretinal Implant RETINA IMPLANT Alpha AMS
This study aims to assess the impact of the subretinal implant RETINA IMPLANT Alpha AMS on the patient's daily life, using validated activities of daily living and questionnaires.
- Trial name
- NCT03561922
- Testing
- RETINA IMPLANT Alpha AMS
- Where
- 2 sites in France
- Volunteers
- 2 people
- Sponsor
- Retina Implant AG
Total Knee Arthroplasty, Knee Disease
Study to Evaluate Long Term Performance and Safety of the Knee Prosthesis (HLS KneeTec Deep Dish)
The aim of this study is to assess the long-term performance and safety of HLS KneeTec Deep Dish knee prosthesis when used in standard medical practice
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT05211141
- Testing
- HLS KneeTec Deep Dish
- Where
- France
- Volunteers
- 119 people
- Sponsor
- Corin
Dental Implant
Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data
Studies on facial trauma are essential to establish an appropriate treatment approach, assess the ability to restore functions and seek ways of prevention.
- Trial name
- NCT05986669
- Where
- 2 sites in Brazil
- Volunteers
- 700 people
- Sponsor
- DSP Industrial Ltda
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.
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