Clinical trials: Prosthetic
Prosthetic Joint Infection
Abbreviated Protocol for Two-Stage Exchange
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days).
- Trial name
- APEX (NCT04662632)
- Testing
- VT-X7 Treatment System with Tobramycin Sulfate, Standard of Care, Two-stage exchange arthroplasty
- Where
- 17 sites in United States
- Volunteers
- 76 people
- Sponsor
- Osteal Therapeutics, Inc.
Upper Limb Amputation
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
This study will compare the functional performance of voluntary opening (VO) and voluntary closing (VC) body powered prostheses.
- Trial name
- NCT02136238
- Testing
- Hosmer 5XA voluntary opening hook, TRS Grip 3 voluntary closing hook
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Limb Deficiencies, Pediatric ALL
Innovative Prosthetic Systems for Pediatric Limb Loss to Accommodate Growth
An immediate fit adjustable prosthetic system is being investigated for children. The age range being recruited is from 3 years up to 18 years old.
- Trial name
- NCT05230004
- Testing
- iFIT prosthesis
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Pennsylvania
Lower Limb Amputation Above Knee (Injury)
C-Leg 3 and C-Leg 4 Study in Transfemoral Amputees
The aim of this post-market study is to confirm that the microprocessor controlled prosthetic knee components (C-Leg 3 and C-Leg 4) in comparison to mechanical knee joints can bring additional benefit to the users primarily on…
- Trial name
- NCT02765035
- Testing
- C-Leg 4, C-Leg 3
- Where
- 2 sites in Austria, Belgium
- Volunteers
- 18 people
- Sponsor
- Otto Bock Healthcare Products GmbH
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
Traumatic Amputation of Arm
Home Study of an Advanced Upper Limb Prosthesis
The overall study objective is to examine the feasibility, acceptance, and benefits of home use of an advanced upper limb prosthetic device as well as the logistical support requirements utilized during 3 months of home usage.
- Trial name
- NCT01551420
- Testing
- Advanced upper limb prosthetic device IMU controlled, Advanced upper limb prosthetic EMG-PR controlled
- Where
- 4 sites in United States
- Volunteers
- 52 people
- Sponsor
- VA Office of Research and Development
Prosthetic Joint Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the…
- Trial name
- NCT03721328
- Testing
- vancomycin hydrochloride and tobramycin sulfate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Osteal Therapeutics, Inc.
Prosthetic Joint Infection
The Influence of Antibiotic Prophylaxis on Intraoperative Prosthetic Joint Infection Cultures
Total joint replacement is a common clinical practice for patients suffering from disabling arthritis, since it provides significant pain relief and functional recovering.
- Trial name
- NCT02413034
- Testing
- Cefazolin, Control group
- Volunteers
- 28 people
- Sponsor
- Parc de Salut Mar
Amputation
Biomechanical Evaluation of a Novel, Compliant Low Profile Prosthetic Foot
The investigators have developed a novel layered low-profile prosthetic foot that is able to provide enhanced compliance without sacrificing strength for individuals with transtibial amputation who have long residual limbs.
- Trial name
- NCT06468059
- Testing
- Layered Low Profile Foot, Prescribed Ankle
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Little Room Innovations, LLC
Prosthetic Joint Infections
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic imaging agent for the detection of prosthetic joint infections in patients.
- Trial name
- PJI (NCT01705496)
- Testing
- [124I]FIAU
- Where
- 10 sites in United States
- Volunteers
- 23 people
- Sponsor
- BioMed Valley Discoveries, Inc
Wounded Warrior, Limb Shortening
AMP30: Autologous Fat Grafting, Amputation Sites Pain: Randomized
We propose a prospective, randomized clinical study to assess the efficacy of minimally invasive autologous fat transfer addressing pain and poor prosthetic fit at amputation sites.
- Conditions
- Wounded Warrior, Limb Shortening, Amputation
- Trial name
- AMP30 (NCT02076022)
- Testing
- Enhanced Fat Grafting, Standard fat graft
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- J. Peter Rubin, MD
Prosthetic Joint Infection
Diagnostic Utility of a Novel Point-of-Care Test of Calprotectin for Revision Total Knee Arthroplasty
The purpose of this study is to investigate whether there are quantifiable differences in the level of calprotectin in the synovial fluid that allow separation of different modes of joint implant failure (e.g.
- Trial name
- NCT03694925
- Testing
- Calprotectin test
- Where
- 2 sites in United States
- Volunteers
- 156 people
- Sponsor
- The Cleveland Clinic
Amputation
Clinical Evaluation of Direct Manufactured Prosthetic Sockets
The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.
- Trial name
- NCT01155024
- Testing
- Traditional fabricated prosthetic socket, Direct manufactured (DM) prosthetic socket
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Ohio Willow Wood
Transtibial Amputation
Evaluation of a Modified Running-specific Prosthetic Foot
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF)…
- Trial name
- NCT02440711
- Testing
- Energy storing foot (ESF), Modified running specific foot (mRSF)
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- University of Washington
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
Prosthesis User, Amputation
Basic Mobility and Balance Performance of Low Active Transfemoral Prosthesis Users With a Powered Prosthetic Knee
This was a prospective case series design investigation with 6 prosthesis user subjects. Subjects performed the Timed up and go (TUG) test and the two minute walk test (2MWT) along with some activities of daily living (ADL), on…
- Trial name
- NCT04799145
- Testing
- Investigational device, Prescribed device
- Volunteers
- 6 people
- Sponsor
- Össur Iceland ehf
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.
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
Amputation
Measures of Gait Efficiency of Three Multi-Axial, Vertical Shock and Energy Storing-Return Prosthetic Feet During Simple & Complex Mobility Activities
Many service members suffering major limb amputation(s) during active duty seek to return to active duty. The purpose of this study is to determine if biomechanic and/or bioenergtic differences exist between popular…
- Trial name
- NCT01404559
- Testing
- Ossur Variflex prosthetic foot, Ossur Ceterus prosthetic foot, Endolite Elite Blade prosthetic foot
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of South Florida
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