Clinical trials: Prosthesis and Implants
Staphylococcal Infections, Joint Prosthesis
StaphVAX Immunogenicity in Orthopedic Implant Patients
S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein.
- Trial name
- NCT00211926
- Testing
- S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Nabi Biopharmaceuticals
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
Osteolysis, Arthroplasty Complications
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
- Conditions
- Osteolysis, Arthroplasty Complications, Instability of Prosthetic Joint, Degenerative Osteoarthritis
- Trial name
- NCT04255966
- Testing
- Plasmafit® Revision Structan®
- Where
- 4 sites in Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Edentulism
Success Rate of Immediately Loaded Implants With Platform Switched Design Placed in Anterior Part of Mandible and Restored With Fixed Prostheses
Change in crestal bone level implants at 5% significance level.
- Trial name
- NCT00780273
- Testing
- Ankylos Implants, Biomet 3i Prevail Implants
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Dentsply International
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
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.
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
Prostheses and Implants
IceExplore TF Liner Alpha Investigation
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system.
- Trial name
- NCT04787484
- Testing
- IceExplore TF breathable liner and Direct Socket drilled with holes
- Volunteers
- 18 people
- Sponsor
- Össur Iceland ehf
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 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
Tooth Disease, Partial Edentulism
A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
- Trial name
- CollegeBowl (NCT00726063)
- Testing
- Nanotite dental implant, Osseotite dental implant
- Where
- United States
- Volunteers
- 241 people
- Sponsor
- ZimVie
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, 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
Hip Arthritis
Post Market, Retrospective Study to Evaluate Patients Implanted With Medacta Versafit Cup DM ™️ 2 Years Post-op
This is a post-market, retrospective with one prospective visit, multi- center study, designed to assess the clinical outcomes, surgical details including Anterior or Posterior surgical approach, and collect all complication data…
- Trial name
- NCT03897387
- Where
- 3 sites in United States
- Volunteers
- 316 people, healthy volunteers welcome
- Sponsor
- Medacta USA
Retinitis Pigmentosa, Cone Rod Dystrophy
Compensation for Blindness With the Intelligent Retinal Implant System (IRIS V2) in Patients With Retinal Dystrophy
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V2). Blind patient suffering from Retinitis Pigmentosa, Cone Rod Dystrophy, or Choroideremia are implanted with an Intelligent…
- Conditions
- Retinitis Pigmentosa, Cone Rod Dystrophy, Choroideremia
- Trial name
- IRIS 2 (NCT02670980)
- Testing
- Intelligent Retinal Implant System
- Where
- 9 sites in Austria, France and 3 more
- Volunteers
- 10 people
- Sponsor
- Science Corporation
Knee Arthritis, Knee Osteoarthritis
In-vivo Wear Behaviour of AS Coated Versus Uncoated Columbus® Total Knee Prosthesis
This clinical study is a Post-Market Clinical Follow-Up (PMCF) measure and is aiming to compare the in-vivo wear behaviour of the Columbus® total knee prosthesis between the standard Cobalt Chromium (CoCr) and the multilayer…
- Conditions
- Knee Arthritis, Knee Osteoarthritis, Primary Osteoarthritis of Knee Nos, Secondary Osteoarthritis of Knee Nos
- Trial name
- COLRAS (NCT05509972)
- Testing
- total knee prosthesis implantation
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- Aesculap AG
Total Knee Arthroplasty, Knee Disease
Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.
- Conditions
- Total Knee Arthroplasty, Knee Disease, Total Knee Replacement, Osteo Arthritis Knee
- Trial name
- NCT04872855
- Testing
- patient with knee arthroplasty
- Where
- 3 sites in France
- Volunteers
- 163 people
- Sponsor
- Corin
Missing Teeth
A Full-Arch Implant- Supported Prosthesis in the Upper and/or Lower Jaw-USA
This study follows subjects who have agreed with their dentist that their failing teeth or missing teeth all need replacing. This study follows their standard routine care with some additional assessments.
- Trial name
- NCT03655990
- Testing
- Treatment with the JUVORA™ Dental Disc
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Juvora Ltd.
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
Jaw, Edentulous, Poor Bone Quality
Treatment With Fixture Microthread™ in Patients With Poor Bone Quality and no Teeth in the Upper Jaw, When Using Two-Stage Surgery
The primary objective of the study is to evaluate the long-term survival rate of individual implants and prostheses when treating edentulous upper jaws of poor bone quality with Fixture MicroThread™ (Micro-Macro).
- Trial name
- NCT00748670
- Testing
- Fixture MicroThread (Micro-Macro)
- Where
- 3 sites in United States, Sweden
- Volunteers
- 23 people
- Sponsor
- Dentsply Sirona Implants and Consumables