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.
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
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.
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
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
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
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
Jaw, Edentulous
Comparison of Early and Late Loading in the Edentulous Upper Jaw Using Cresco Prosthetic System on Straumann Implants
Comparison of early and late loading of implants supporting full each prosthesis in upper jaw, using the Cresco prosthetic system on Straumann implants.
- Trial name
- NCT00922935
- Testing
- Cresco, Straumann components
- Where
- 2 sites in Sweden
- Volunteers
- 36 people
- Sponsor
- Institut Straumann AG
Refractory Bone or Joint Infections
Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections
To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.
- Trial name
- NCT02569541
- Testing
- sodium fusidate
- Where
- 19 sites in United States
- Volunteers
- 30 people
- Sponsor
- Arrevus Inc.
Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury)
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
- Conditions
- Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
- Trial name
- NCT04239222
- Testing
- Revo-M, Taleo, Proflex XC
- Where
- 4 sites in United States
- Volunteers
- 27 people
- Sponsor
- Otto Bock Healthcare Products GmbH
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.
Hernia
Feasibility of Permacol Use in Infected Fields
This pilot study is to examine the feasibility of using Permacol Surgical Implant in the repair of abdominal wall defects after removal of infected prosthetic mesh
- Trial name
- NCT00820040
- Testing
- acellular porcine dermal collagen mesh
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
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.
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
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
Amputation
Clinical Investigation (Beta) of a New Developed Prosthetic Knee
The aim of this investigation is to evaluate the efficacy of the investigational device regarding performance improvements and satisfaction in descending activities for moderate to high active prosthesis users within the intended…
- Trial name
- NCT06748729
- Testing
- Navii Knee
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Össur Iceland ehf
Amputation, Amputation; Traumatic, Leg, Lower
Socket Cooling Effectiveness Take Home 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, Amputation; Traumatic, Leg, Lower, Amputation Stump, Limb; Absence, Congenital, Lower
- Trial name
- NCT04484805
- Testing
- ICE Condition
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Liberating Technologies, Inc.