Clinical trials: Prosthetic
Transtibial Amputee
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic…
- Trial name
- NCT03164356
- Testing
- Bioimpedance monitor
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- University of Washington
Urinary Incontinence
Adjustable Continence Therapy (ACT) Device for the Treatment of Female Stress Urinary Incontinence
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are…
- Trial name
- ACT (NCT00113555)
- Testing
- ACT (Adjustable Continence Therapy)
- Where
- 7 sites in United States, Canada
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- Uromedica
Amputation Stump, Amputation
Moisture Management Liner At-Home Evaluation
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 unbreathable and non-thermally conductive materials that can create a warm…
- Conditions
- Amputation Stump, Amputation, Amputees, Lower Limb Deformity
- Trial name
- NCT05124873
- Testing
- Moisture Management Liner
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Liberating Technologies, Inc.
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.
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
Lower Extremity Amputation
Community Walking Trials: Comparing Prosthetic Feet
The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot.
- Trial name
- NCT03703232
- Testing
- Investigational prosthetic foot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- University of Washington
Prosthetic Joint Infection, Vancomycin
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
- Conditions
- Prosthetic Joint Infection, Vancomycin, Joint Diseases
- Trial name
- NCT04042233
- Testing
- Experimental Intraosseous vancomycin 500mg in 250 mL NS, Standard IV administration of vancomycin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- The Methodist Hospital Research Institute
Hernia, Ventral
Complex Ventral Hernia Repair Using Biologic or Synthetic Mesh
Hernias are often treated using a prosthetic mesh to add support to the healing wound. Prosthetic meshes have been used for decades to repair ventral hernias, level 1 data regarding which type of mesh to use is limited.
- Trial name
- CVHR (NCT02041494)
- Testing
- Ventralight, Strattice
- Where
- United States
- Volunteers
- 165 people
- Sponsor
- Hobart Harris
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
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
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.
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
Amputation
Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations
Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to…
- Trial name
- BestBikeFit (NCT03828331)
- Testing
- Prosthetic/Bicycle Configuration
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- VA Office of Research and Development
Amputation, Hyperhidrosis
Qbrexza Cloths for Hyperhidrosis of Amputation Sites
This is a Prospective, Double Blinded, Placebo Controlled, Randomized, Cross-over trial using Qbrexza Cloths to treat hyperhidrosis of amputation sites.
- Trial name
- NCT04924036
- Testing
- glycopyrronium cloths
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- University of Utah
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
Osteomyelitis
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by Staphylococci.
- Trial name
- NCT00428844
- Testing
- daptomycin, vancomycin, teicoplanin
- Where
- 26 sites in United States, Russia and 1 more
- Volunteers
- 75 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
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
Tetraplegia
Providing Brain Control of Extracorporeal Devices to Patients With Quadriplegia
This research study is being done to develop a brain controlled medical device, called a brain-machine interface or BMI, that will provide people with a spinal cord injury some ability to control an external device such as a…
- Trial name
- NCT01849822
- Testing
- Neural Prosthetic System
- Where
- 3 sites in United States
- Volunteers
- 1 people
- Sponsor
- Richard A. Andersen, PhD
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