Clinical trials: Prostheses
Stenoses
Pivotal Study for the FLAIR Endovascular Stent Graft
This study compared the FLAIR™ Endovascular Stent Graft to balloon angioplasty in patients with stenoses at the venous anastomosis of a synthetic AV access graft.
- Trial name
- NCT00678249
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 227 people
- Sponsor
- C. R. Bard
Spinal Cord Injuries
Active Powered Prosthesis (APEX) for Spinal Cord Injury
The Active Powered Prosthesis (APEX) (AbiliTech Medical Inc., Minneapolis, MN) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities.
- Trial name
- NCT03696927
- Testing
- Active Powered Prosthesis (APEX) for Spinal Cord Injury
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- AbiliTech Medical Inc.
Erectile Dysfunction, Impotence
PROPPER Prospective Registry of Outcomes With Penile Prosthesis
The purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.
- Trial name
- PROPPER (NCT01383018)
- Testing
- AMS Penile Prosthesis Devices
- Where
- 11 sites in United States, Canada
- Volunteers
- 1,457 people
- Sponsor
- Boston Scientific Corporation
Inflammatory Reaction Due to Ocular Lens Prosthesis
Efficacy and Safety Study of IBI-10090 in Patients Undergoing Cataract Surgery
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
- Trial name
- NCT01048593
- Testing
- IBI-10090
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- ICON Bioscience Inc
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
Prosthesis User, Amputation
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and…
- Trial name
- NCT04388488
- Testing
- CONNECT TF adaptable socket system, Any conventional handmade socket
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Össur Iceland ehf
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
Amputation Stumps, Amputees
Moisture Management Liner Effectiveness Study
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm…
- Conditions
- Amputation Stumps, Amputees, Amputation, Lower Limb Deformities, Congenital
- Trial name
- NCT04427007
- Testing
- Moisture Management Liner, Control Liner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
Prosthesis User, Amputation
Clinical Investigation (Beta) of Power Knee Mainstream - Dynamic
Prospective two group cross over investigation, comparing the investigational device (Power Knee, a powered microprocessor controlled prosthetic knee) and subjects prescribed microprocessor prosthetic knee (MPK).
- Trial name
- NCT04787627
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Össur Iceland ehf
Surgical Wound, Revision Total Knee Arthroplasty
Closed Incision Negative Pressure Therapy Versus Standard of Care Surgical Dressing in Revision Total Knee Arthroplasty
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care…
- Conditions
- Surgical Wound, Revision Total Knee Arthroplasty, Wounds and Injuries, Joint Disease
- Trial name
- PROMISES (NCT03274466)
- Testing
- Closed Incision Negative Pressure Therapy (ciNPT), Standard of Care Dressing
- Where
- 17 sites in United States
- Volunteers
- 294 people
- Sponsor
- KCI USA, Inc
Osteoarthritis of the Hip
The Metaphyseal Hip Prosthesis - Total Hip
The purpose of this study is to analyze stability, safety and efficacy of the Metaphyseal Hip Prosthesis (MHP) compared to the Stanmore hip replacement.
- Trial name
- NCT01501955
- Testing
- Metaphyseal Hip Prosthesis, Stanmore
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Zimmer Biomet
Osteoarthritis
Arthrex Eclipse™ Shoulder Prosthesis
A Prospective, Randomized, Multicenter Study comparing the Safety and Effectiveness of Arthrex's Eclipse™ Shoulder to the Univers™ II Shoulder Prosthesis in patients with a degenerative joint disease.
- Trial name
- NCT01790113
- Testing
- Univers™, Eclipse™ Total Shoulder Replacement
- Where
- 16 sites in United States
- Volunteers
- 303 people
- Sponsor
- Arthrex, Inc.
Arthritis
Comparison of ARPE Prosthesis With the Literature
This study is designed to document the objective and subjective measurements after trapeziometacarpal athroplasty with ARPE prosthesis and to compare those to literature values of outcome after trapeziectomy and trapeziectomy…
- Trial name
- NCT01904019
- Where
- Belgium
- Volunteers
- 100 people
- Sponsor
- Zimmer Biomet
Non-inflammatory Joint Diseases
Metal on Metal Versus Ceramic on Metal Hip Replacement
The purpose of this study is to compare the performance of artificial hips with metal heads and metal sockets to artificial hips with ceramic heads articulating with metal socket components.
- Trial name
- NCT00208494
- Testing
- Total Hip Replacement
- Where
- 9 sites in United States, Canada
- Volunteers
- 392 people
- Sponsor
- DePuy Orthopaedics
Prosthesis User, Amputation
An Investigation of Functional Improvements in the RHEO KNEE Compared to Hydraulic Microprocessor Controlled Knees (MPKs)
The aim of this study was to evaluate the mobility, perceived safety and functioning of unilateral transfemoral (TF) amputees using the Rheo Knee XC compared to their existing prosthetic knee (RHEO KNEE II, III or Genium, X2 or…
- Trial name
- NCT04023578
- Testing
- RHEO KNEE XC
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Össur Iceland ehf
Amputation
EmPOWERing Active Seniors With Energy
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
- Trial name
- EASE (NCT02958553)
- Testing
- emPOWER Ankle, Subject's own passive prosthesis
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Otto Bock Healthcare Products GmbH
Amputation, Amputation; Traumatic, Leg, Lower
Clinical Outcomes With Passive MPKs vs. Powered Prosthetic Knees
The goal of this proposed project is to gather community-based data from the K4-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to…
- Conditions
- Amputation, Amputation; Traumatic, Leg, Lower, Limb; Absence, Congenital, Lower, Prosthesis User
- Trial name
- NCT05267639
- Testing
- Power Knee
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.
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
Total Laryngectomy
Long-term Clinical Feasibility of the New Indwelling Provox Vega 20 Voice Prosthesis
The purpose of this study is to investigate long-term clinical feasibility of a new voice prosthesis and insertion system Provox Vega 20 with SmartInserter) for voice rehabilitation after total laryngectomy.
- Trial name
- NCT00661570
- Testing
- Provox Vega voice prosthesis (20 Fr)
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Atos Medical AB
Prostheses, Upper Limb Amputation Below Elbow
Wireless Prosthetic Control Effectiveness Study
The goal of this proposed project is to evaluate the effectiveness of our novel wireless electrode system, which the investigators refer to as the Asterisk system, on transradial prosthesis users.
- Trial name
- NCT06821412
- Testing
- ASTERISK System, Wired Configuration
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Liberating Technologies, Inc.