Clinical trials: Prosthesis
Osteoarthritis
The Press Fit Condylar (P.F.C.) Sigma Rotating Platform (RP) TC3 Revision Knee in Revision Knee Arthroplasty
The purpose of this study is to evaluate the long-term clinical and functional performance of the P.F.C. Sigma Rotating Platform TC3 knee system in revision knee surgery and to determine whether the implant design results in a…
- Trial name
- TC3 (NCT00733681)
- Testing
- PFC Sigma RP TC3 Revision knee system
- Where
- 9 sites in France, Germany and 2 more
- Volunteers
- 181 people
- Sponsor
- DePuy International
Infection of Total Knee Joint Prosthesis, Aseptic Loosening of Prosthetic Joint
Surgical / Economic Effect of the Aquamantys System in Blood Management for Aseptic and Septic Revision TKA
To assess the surgical and economic effectiveness of the Aquamantys System in managing intra- and post-operative blood loss, and reducing transfusion needs in patients undergoing both aseptic and septic revision total knee…
- Trial name
- NCT02266407
- Testing
- Aquamantys System
- Where
- Germany
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Non-inflammatory Degenerative Joint Disease, Osteoarthritis
Ceramic On Ceramic (COC) 36mm PAS IDE Rollover Subjects; Ceramic Acetabular Bearing With Ceramic Femoral Head in Total Hip Replacement
This study is intended to gather medium (5- to 7-years) and long-term (minimum 8- to 10-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic (COC) Total Hip System…
- Conditions
- Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
- Trial name
- COC36mmPAS (NCT02096198)
- Where
- 5 sites in United States
- Volunteers
- 81 people
- Sponsor
- DePuy Orthopaedics
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
Penile Implantation, Infections
Next Generation Sequencing Versus Traditional Cultures for Clinically Infected Penile Implants: Impact of Culture Identification on Outcomes
Randomized prospective study to evaluate next generation sequencing (NGS) and standard-of-care culture for clinically infected penile implants and to compare outcomes with identification of microbes.
- Trial name
- NCT05287438
- Testing
- Next-Generation DNA Sequencing, Standard Culture
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- MicroGenDX
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
Osteoarthritis Thumb
Post Market Clinical Follow-Up TOUCH® CMC 1
Because severe pain, weakened pinch and grip strength produce functional disabilities, the basal joint of the thumb is the most common site of surgical reconstruction in the upper limb due to OA.
- Trial name
- NCT06546306
- Testing
- TOUCH® CMC 1
- Where
- 6 sites in France
- Volunteers
- 216 people
- Sponsor
- Keri Medical SA
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
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
Osteoarthritis, Knee
GMK-UNI Anatomical UKA: Fixation of Cemented vs Cementless Designs
Unicompartmental knee arthroplasty (UKA) is the principal surgical alternative to the total knee arthroplasty (TKA) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (OA) of the knee.
- Trial name
- NCT03522025
- Testing
- Unicompartmental Knee Arthroplasty (UKA)
- Where
- 5 sites in France, Switzerland
- Volunteers
- 70 people
- Sponsor
- Medacta International SA
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
Talus, Ankle Arthropathy
Retrospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement
This study is a retrospective analysis of patients who underwent surgery using a total talus replacement (TTR) implant with or without concurrent total ankle replacement and/or subtalar fusion.
- Trial name
- RECLAIM (NCT05231304)
- Testing
- Total Talus Replacement (TTR), Total Ankle Total Talus Replacement (TATTR), Total Ankle Total Talus Replacement + Subtalar Fusion (TATTR + STJ)
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Restor3D
Osteoarthritis
Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a…
- Trial name
- NCT02583113
- Testing
- Total and Unicompartment Knee Replacement
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medacta USA
Breast Reconstruction
Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses.
- Trial name
- Adjunct (NCT00948948)
- Testing
- Silicone Gel-Filled Mammary Prostheses
- Where
- United States
- Sponsor
- Mentor Worldwide, LLC
Total Laryngectomy
Long Term Use of the Provox Vega 22.5
The purpose of this study was to investigate the long-term feasibility of the new Provox Vega 22.5 voice prosthesis (outer diameter of 22.5 French) and its insertion system (SmartInserter) in laryngectomized patients who…
- Trial name
- NCT00884910
- Testing
- Provox Vega voice prosthesis 22.5 Fr
- Where
- Netherlands
- Volunteers
- 33 people
- Sponsor
- Atos Medical AB
Disk, Herniated
A Pilot Study of the InterCushion Disc Nucleus Prosthesis (DNP) in Patients Receiving Discectomy
The primary endpoints of the investigation will include assessment of the maintenance of disc height demonstrated by radiographic evidence based on plain radiographs and MRI and relief of pain as measured by Visual Analog Scale…
- Trial name
- NCT01652053
- Testing
- Disc Nucleus Replacement (InterCushion DNP)
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Vertebral Technologies, Inc.
Swallowing Disorders
NewBreez Safety and Efficacy Evaluation
The objective of this clinical study is to evaluate the safety and efficacy of the NewBreez intra-laryngeal implant in patients with dysfunctional larynx.
- Trial name
- NCT01587664
- Testing
- NewBreez ILP
- Where
- 2 sites in Belgium, France
- Volunteers
- 2 people
- Sponsor
- ProTiP Medical
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.
Shoulder Posterior Instability, Shoulder Anterior Instability
Evaluating Upper Limb Movement Precision With AuReha in People With One-Sided Motor Impairment
The clinical investigation is designed as a controlled, two-arm, intra-patient, non-randomized interventional study aimed at assessing the capabilities of the AuReha system in detecting upper limb movement precision in patients…
- Conditions
- Shoulder Posterior Instability, Shoulder Anterior Instability, Shoulder Anterior Latarjet Instability, Adhesive Capsulitis, Shoulder
- Trial name
- NCT07133100
- Testing
- Upper limb rehabilitation wearable device
- Where
- Italy
- Volunteers
- 52 people
- Sponsor
- DigitalRehab
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis
This study is a non-randomized, consecutive enrollment, one-year post-approval study of patients who are treated with the Ascension® MCP.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Osteoarthritis, Post-traumatic Arthritis
- Trial name
- MCP (NCT02408471)
- Testing
- Ascension® MCP Finger Implant
- Where
- 9 sites in United States
- Volunteers
- 97 people
- Sponsor
- Smith & Nephew, Inc.