Clinical trials: Prostheses
Larynx Cancer
Clinical Feasibility of New Tracheoesophageal Puncture Set
During a total laryngectomy a puncture is created in the tracheoesophageal wall and a voice prosthesis is inserted. With this voice prosthesis the patient learns to speak again.
- Trial name
- NCT01045057
- Testing
- Puncture Set and Flexible Protector
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 27 people
- Sponsor
- Atos Medical AB
Traumatic Amputation of Arm
Interface Kinematics of Transhumeral Prosthetic Sockets Using XROMM
The purpose of this pilot study was to conduct a head-to-head comparison of two designs for transhumeral level upper limb prosthetic sockets: a traditional socket design and a socket design hypothesized to provide greater…
- Trial name
- NCT01546675
- Testing
- Skeletal Stabilization
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- US Department of Veterans Affairs
Dizziness Chronic
Pilot Project on External Vestibular Prosthesis in Chronic Subjective Dizziness
Researchers are gathering information on the safety and effectiveness of a new device called the BalanceBelt.
- Trial name
- NCT02048670
- Testing
- Balance Belt
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Vestibular Disorder, Dizziness
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability
The goal of this study is to evaluate a tactile prosthesis that provide individuals who have demonstrated chronic imbalance with help to maintain a correct sense of orientation with respect to the gravity and improve posture…
- Trial name
- BALCAP (NCT03330262)
- Testing
- BALCAP prosthesis
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Barron Associates, Inc.
Osteoarthritis
Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses
The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior…
- Trial name
- NCT00837447
- Testing
- Total knee replacement with NexGen CR knee prosthesis, Total knee replacement(TKR) with Nexgen CR-flex
- Volunteers
- 54 people
- Sponsor
- Ewha Womans University
Amputation of Lower Limb
Assessment of Safety and Performances of a 3D Printed Prosthetic Foot: A Pilot Study
A dynamic energy storage and return foot prosthesis is a type of prosthesis designed to mimic and restore the functionality and natural movement of the limb that has been amputated.
- Trial name
- NCT06938087
- Testing
- 3D printed prosthesis foot, Current prosthesis foot
- Where
- Italy
- Volunteers
- 3 people
- Sponsor
- Istituto Nazionale Assicurazione contro gli Infortuni sul Lavoro
Amputation
Upper Limb Loss Perturbation Response
Recent investigations have suggested that persons with upper limb loss experience a high prevalence of falls with a quarter of reported falls resulting from a trip.
- Trial name
- NCT04274218
- Testing
- Perturbation
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Total Laryngectomy
Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy
This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients.
- Trial name
- N08HME (NCT00942903)
- Testing
- Provox Xtra HME
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Atos Medical AB
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
Cardiomyopathy
Cardiac MRI for Metal on Metal Hip Resurfacing
There may be a relationship between heart function and the metal ion levels in patients having undergone total hip replacement. The idea is to use results from a clinical cardiac MRI to assess heart function in a sample of 30…
- Trial name
- CardiacMRI (NCT02892448)
- Testing
- Cardiac magnetic resonance imaging (CMR)
- Where
- Canada
- Volunteers
- 35 people
- Sponsor
- Ottawa Hospital Research Institute
Lower Extremity Amputation
Adherence and Perspiration While Wearing Lower Limb Prostheses
Individuals with lower limb amputation often complain about uncomfortable residual limb skin temperatures and the accumulation of sweat inside their prostheses.
- Trial name
- NCT03900845
- Testing
- Dynamic Air Exchange - Rising Edge Design (DAE-RED), Perforated elastomeric liner, As-prescribed prosthesis
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seattle Institute for Biomedical and Clinical Research
Lower Extremity Amputation
Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation
When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available.
- Trial name
- NCT03532100
- Testing
- Torsionally adaptive prosthesis with 0:1 coupling ratio, Torsionally adaptive prosthesis with 1:6 coupling ratio, Torsionally adaptive prosthesis with 1:4 coupling ratio
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- VA Office of Research and Development
Cerebral Palsy, Prosthesis User
Use of Low Cost Prostheses to Improve Upper Extremity Function in Children With Cerebral Palsy
The purpose of the study is to assess the effectiveness of an upper extremity prosthesis in improving the upper extremity function of children with cerebral palsy who have limited use of their hands.
- Trial name
- NCT03122171
- Testing
- Occupational Therapy Treatment
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- NYU Langone Health
Arthroplasty, Replacement, Knee
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.
- Trial name
- X3vsN2Vac (NCT02525588)
- Testing
- Triathlon CS fixed bearing total knee prosthesis
- Where
- Netherlands
- Volunteers
- 100 people
- Sponsor
- Stryker Orthopaedics
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
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
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
Total Knee Arthroplasty
Effect of Low Dose Corticosteroids on Perioperative Markers of Thrombosis and Fibrinolysis in Total Knee Arthroplasty
One postoperative complication following unilateral or bilateral total knee arthroplasty is thrombosis (blood clot formation). In this prospective, double-blinded randomized controlled clinical trial, researchers are…
- Trial name
- NCT01815918
- Testing
- Hydrocortisone
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Hospital for Special Surgery, New York
Jaw, Edentulous
Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function
Brånemark System® dental implant osseointegration was introduced in 1965 as a novel approach to the replacement of missing teeth.
- Trial name
- NCT03862482
- Testing
- Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1), Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2), Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)
- Where
- Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Université de Montréal
Amputation, Prosthesis User
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.
- Trial name
- NCT07159490
- Testing
- Standard-of-care prosthetic foot, Standard-of-care prosthetic foot with heel-stiffening wedge, Standard-of-care prosthetic foot of one category greater stiffness
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- VA Puget Sound Health Care System