Clinical trials: Artificial Limbs
Maxillofacial Injuries, Maxillofacial Prosthesis Implantation
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital.
- Conditions
- Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
- Trial name
- NCT04279925
- Testing
- ORIF (Open reduction internal fixation): locally-made miniplate and screw, ORIF: Imported miniplate and screw
- Where
- Indonesia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Lower Limb Amputation Below Knee (Injury)
Wear and Tear Evaluation of New Nike Sport Sole for Runnnig Prosthesis
Running Specific Feet are based on the original Flex-Foot design using the energy storage and release function as the main design feature. Running specific prosthetic feet are intended for running and jogging.
- Trial name
- NCT04787640
- Testing
- Nike Sport Sole
- Volunteers
- 3 people
- Sponsor
- Össur Iceland ehf
Lower Limb Amputation
Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
- Trial name
- DoD (NCT03927404)
- Testing
- Active vacuum test prosthesis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Indiana University
Prosthesis User, Amputation
An Investigation on Function and Performance of a New Microprocessor Controlled Prosthetic Knee
This investigation aims to compare the functional performance of a new passive microprocessor-controlled Prosthetic Knee to subjects usual microprocessor-controlled prosthetic knee.
- Trial name
- NCT05523349
- Testing
- NAVii
- Where
- 4 sites in United States, Iceland
- Volunteers
- 14 people
- Sponsor
- Össur Iceland ehf
Locked-In Syndrome
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system.
- Trial name
- UNP (NCT02224469)
- Testing
- ECoG (electrocorticography) sensing
- Where
- Netherlands
- Volunteers
- 6 people
- Sponsor
- UMC Utrecht
Transfemoral Amputation, Artificial Limbs
Assist-Knee: Energy-Harvesting Knee Prosthesis
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Assist-Knee to harvest energy…
- Trial name
- NCT04023045
- Testing
- Assist-Knee, Habitual Prosthesis
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Orthocare Innovations, LLC
Traumatic Amputation of Lower Extremity
Effects of Wearing a Powered Ankle-Foot Prosthesis on Amputee Walking
Amputees wearing a conventional prosthesis require 20-30% more metabolic energy to walk at the same speeds as non-amputees and this discrepancy is more apparent at faster walking speeds.
- Trial name
- NCT00869947
- Testing
- Powered ankle-foot prosthesis, No device
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if photodynamic therapy has an effect on bacterial skin colonization and decrease number of…
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Trial name
- PHOMIC (NCT04067843)
- Testing
- Photodynamic treatment
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Non-inflammatory Degenerative Joint Disease
36 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement
This study is a supplement to the 28 mm Ceramic-on-Ceramic study which was designed to evaluate artificial hips with a 28 mm ceramic head and liner to determine whether they perform as well as artificial hips with a 28 mm ceramic…
- Trial name
- NCT00953719
- Testing
- 36 mm ceramic head on a ceramic acetabular liner, 28 mm ceramic head on a polyethylene acetabular liner
- Where
- 5 sites in United States
- Volunteers
- 243 people
- Sponsor
- DePuy Orthopaedics
Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease
Randomized Controlled RSA Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
This is a single center, prospective, randomized controlled study. The primary objective of this study is to measure migration over two years with RSA.
- Conditions
- Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity
- Trial name
- NCT03409666
- Testing
- Taperloc Complete Microplasty stem, Taperloc Complete Reduced Distal stem
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Zimmer Biomet
Pressure Ulcer, Ankle, Prosthesis User
Limb Health and Socket Pressure in Response to Powered Ankle Protheses
this project seeks to understand and quantify the effects of powered transtibial prostheses on socket loading and direct measures of residual limb health so as to inform the optimization of prosthesis fit.
- Conditions
- Pressure Ulcer, Ankle, Prosthesis User, Prosthesis Durability, Mobility Limitation
- Trial name
- OPORP (NCT05112679)
- Testing
- PROPRIO FOOT® by Ossur & Empower ankle by Ottobock
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Indiana University
Aortic Valve Stenosis
5 Year Observation of Patients With PORTICO Valves
The purpose of this clinical investigation is to further assess the performance and safety profile of the commercially-available Portico™ TAVI System in patients with severe symptomatic aortic stenosis.
- Trial name
- PORTICO-1 (NCT01802788)
- Testing
- St Jude Medical Portico replacement aortic valve, Transcatheter Aortic Valve Implant
- Where
- 60 sites in Australia, Belgium and 11 more
- Volunteers
- 1,032 people
- Sponsor
- Abbott Medical Devices
Infection of Total Hip Joint Prosthesis
Evaluating Advantages of Prevena After Hip and Knee Arthroplasty
Determine the extent to which application of the Prevena vacuum system to clean surgical incisions immediately following surgical procedure (total hip or total knee arthroplasty) will reduce the rates of: readmission to hospital…
- Trial name
- NCT01854138
- Testing
- Prevena Incision Management System
- Where
- United States
- Volunteers
- 248 people
- Sponsor
- ProMedica Health System
Infection and Inflammatory Reaction
Pending Failure in Hard-hard Total Hip Arthroplasty
During last 6 years approximately 10.000 ceramic balls and 5.000 ceramic liners have been implanted in the region Emilia-Romagna in Italy (4 million Every single year approximately 60.000 hip prostheses are implanted in Italy.
- Trial name
- PF (NCT02427984)
- Testing
- Metal ions dosage and evaluation of local/systemic reaction, Noise registration and metal ions determination, Metal ions dosage, evaluation of local/systemic reaction, noise registration
- Where
- Italy
- Volunteers
- 148 people
- Sponsor
- Istituto Ortopedico Rizzoli
Neurogenic Bladder, Urinary Retention
Connected Catheter - Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Neurogenic Bladder, Urinary Retention, Urologic Diseases
- Trial name
- NCT04059159
- Testing
- Connected Catheter
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Spinal Singularity
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.
Amputation, Artificial Limbs
Functional Performance Evaluation of NU-FlexSIV Socket
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
- Trial name
- NCT02678247
- Testing
- Northwestern University Flexible Sub-Ischial Vacuum Socket, Ischial Containment Socket
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Avascular Necrosis, Osteoarthritis
PMCF Study on the Safety and Performance of the Alloclassic Variall Cup Ceramic Bearing System in Total Hip Arthroplasty
The study is a multicenter, prospective, non-randomized, non-controlled consecutive cohort post-market clinical follow-up study.
- Conditions
- Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Posttraumatic Arthritis
- Trial name
- NCT03672370
- Where
- 2 sites in Austria
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Dizziness
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of…
- Trial name
- NCT00889824
- Testing
- balance prosthesis
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Washington University School of Medicine
Joint Diseases
28 mm Ceramic-on-Ceramic Acetabular Cup Total Hip Replacement Study
The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
- Trial name
- NCT00208507
- Testing
- 28 mm ceramic head on ceramic acetabular liner., 28 mm ceramic head on polyethylene liner
- Where
- 2 sites in United States
- Volunteers
- 264 people
- Sponsor
- DePuy Orthopaedics