Clinical trials: Prosthesis, open to volunteers
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
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.
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
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.
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
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
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.
Amputation
Pro APP Prosthetic Outcome Registry
A national, multi-center registry of patients using lower-limb prosthesis, their profiles and devices, and their long-term follow-up and clinical outcomes.
- Trial name
- NCT06210620
- Where
- United States
- Volunteers
- 2,000 people
- Sponsor
- Össur Iceland ehf
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
Amputation of Upper Limb
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients
This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to >20 years in function.
- Trial name
- ReTHro (NCT06753110)
- Testing
- OPRA transhumeral
- Where
- 6 sites in Australia, Austria and 3 more
- Volunteers
- 70 people
- Sponsor
- Integrum
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
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.
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
Amputation, Amputation, Traumatic
Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control
The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years…
- Conditions
- Amputation, Amputation, Traumatic, Amputation, Congenital, Prosthesis User
- Trial name
- NCT07011420
- Testing
- Experimental socket with 4 untargeted channels active, Experimental socket with 8 untargeted channels active, Experimental socket with up to 16 untargeted channels active
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Liberating Technologies, 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
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
Tendon Injuries
Study Evaluating the Safety and Efficacy of the TMChM Prosthesis in the Treatment of People With Chronic Flexor Tendon Fingers Injuries
The objective of the study is to evaluate the safety and effectiveness of the TMChM tendon prosthesis in the treatment of patients with chronic flexor tendon injuries of the fingers, compared with a reference tendon prosthesis…
- Trial name
- TMChM (NCT07910123)
- Testing
- Two-Stage Flexor Tendon Reconstruction with Temporary Tendon Prosthesis Implantation
- Where
- 2 sites in Poland
- Volunteers
- 86 people
- Sponsor
- ChM sp. z o.o.
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
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.
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