Clinical trials: Artificial Limbs
Upper Limb Amputation
Brasthesis Prosthetic Harness for Women Veterans With Upper Limb Amputations
This project tests Brasthesis, a new product for women Veterans with upper limb loss. Brasthesis incorporates the harnessing straps that hold the prosthesis to the body into a heavy-duty sports bra.
- Trial name
- Brasthesis (NCT05179395)
- Testing
- Brasthesis
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- VA Office of Research and Development
Hip Injuries
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
In a previous study conducted within the Center for Musculoskeletal Research (CMR) on Total Hip Arthroplasties (THA), it was determined that the investigators could simultaneously capture in vivo sound and motion of the femoral…
- Trial name
- THA (NCT01833481)
- Testing
- Fluoroscopy surveillance of patients while walking
- Where
- 3 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- The University of Tennessee, Knoxville
Diabetes Mellitus, Leg Injuries
Prosthetic Components and Stability in Amputee Gait
The biomechanics of changing direction while walking has been largely neglected despite its relevancy to functional mobility. In addition, an increased risk of injury can be associated with turning due to a decrease in stability.
- Conditions
- Diabetes Mellitus, Leg Injuries, Traumatic Amputation
- Trial name
- NCT00167778
- Testing
- Transverse plane rotation adaptor pylon, Rigid pylon
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Hypothermia
Observational Examination of Thermoregulation in Total Joint Arthroplasty
Total joint patients have poor outcomes with infection since they are having permanent hardware implanted. Infection prevention in this group is therefore critical and a major source of discussion in both the orthopedic and…
- Trial name
- NCT02225743
- Testing
- Observation Of Temperature
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants
Effect of Photodynamic Therapy on Skin Microbiome. Single Center Study (PHOMIC-II)
The overarching aim of this research project is to prevent orthopedic implant-associated infections. This study aims to investigate if PDT has an effect on bacterial skin colonization in order to improve skin antisepsis…
- Conditions
- Postoperative Wound Infection Deep Incisional Surgical Site, Prosthesis and Implants, Surgical Site Infection, Prosthetic Joint Infection
- Trial name
- NCT04618276
- Testing
- Photodynamic Therapy
- Where
- Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Amputation of Hip and Thigh, Level Unspecified
Assessment of Disability Compensation With the C-LEG COMPACT 2 Knee (Ref. 3C60 et 3C60=ST)
Moderately active amputees may have lost their limb due to diabetes, vascular conditions, trauma, tumour or congenital causes. These amputees currently cannot benefit from having a computerised knee because of the performance…
- Trial name
- NCT02382991
- Testing
- 3C60-NMPK, NMPK-3C60
- Where
- 15 sites in Austria, France and 1 more
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Otto Bock France SNC
Peripheral Artery Disease
Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD
This study will evaluate how well Humacyte's Human Acellular Vessel (HAV) works when surgically implanted into a leg to improve blood flow in patients with peripheral arterial disease (PAD).
- Trial name
- NCT02887859
- Testing
- Human Acellular Vessel (HAV)
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Humacyte, Inc.
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.
Retinitis Pigmentosa
Object Finder for a Retinal Prosthesis
The proposed project seeks to provide object recognition as a feature in a retinal implant system. Participants will be able to direct an object recognition application to find a desired object in the field of view of the…
- Trial name
- NCT04319809
- Testing
- Object recognition subsystem
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Minnesota HealthSolutions
Implant Capsular Contracture
Chemically Assisted Capsulectomy-A New Clinical Approach
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
- Trial name
- NCT00758667
- Testing
- Mesna
- Volunteers
- 20 people
- Sponsor
- Vanderbilt 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
Other and Unspecified Complications of Amputation Stump
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
The purpose of this study is to determine if transfemoral amputees of varied etiology will demonstrate increased function, safety and quality of life following accommodation with a new knee prosthesis as compared to their former…
- Trial name
- NCT01473992
- Testing
- Otto Bock C-Leg, Otto Bock Genium
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Jason Highsmith
Arthroplasty Replacement Knee, Knee Prosthesis
In Vivo Determination of 3D Patellofemoral Mechanics
This study will analyze the tibio-femoral and patellofemoral (motion) and mechanics (forces) of participants having a normal knee or a total knee arthroplasty (TKA) using one or two different (TKA) devices Low Contract Stress…
- Trial name
- Patella (NCT01290627)
- Testing
- Subjects implanted with DePuy LCS PS RP TKA, Subjects implanted with DePuy Sigma PS RP TKA
- Where
- 4 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The University of Tennessee, Knoxville
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.
Edentulous Jaw
Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible
The aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a…
- Trial name
- NCT03509402
- Testing
- ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm, ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm
- Volunteers
- 30 people
- Sponsor
- University of Campania Luigi Vanvitelli
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
Prosthesis Failure
Investigation on Failure Time Analysis of a New TPE Material in the Iceform Liner
Durability evaluation of a new material blend in the Iceform liner and Iceform sleeve.
- Trial name
- NCT05040165
- Testing
- Iceform liner and sleeve
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Össur Iceland ehf
Knee Prosthesis, Knee Replacement Arthroplasty
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee…
- Trial name
- Sigma MB TKA (NCT01714492)
- Testing
- Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- The University of Tennessee, Knoxville
Retinitis Pigmentosa
The Perceptual Experience of Argus II Users
This Basic Experimental Studies Involving Humans (BESH) study investigates phosphene perception and performance factors in blind participants implanted with the Argus II retinal prosthesis system.
- Trial name
- NCT05285618
- Testing
- Argus II
- Where
- 3 sites in United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- University of California, Santa Barbara
Knee Prosthesis, Knee Arthroplasty
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing…
- Trial name
- PFC & TC3 (NCT01290640)
- Testing
- DePuy fixed-bearing Total Condylar III (TC3) TKA, DePuy PFC Rotating Platform TC3 TKA
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- The University of Tennessee, Knoxville