Clinical trials: Amputation With Osseointegration
Amputation
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System.
- Trial name
- TTeOPRA+MB (NCT06391697)
- Testing
- eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Brigham and Women's Hospital
Prosthesis, Lower Limb Amputation Knee
Clinical and Functional Assessment of Patients With Transfemoral Amputation Treated With Osteointegrated Implant
Limb amputation is a traumatic event that significantly reduces the ability to perform daily activities, impairs mobility, and lowers quality of life.
- Conditions
- Prosthesis, Lower Limb Amputation Knee, Amputation; Traumatic, Leg, Lower
- Trial name
- OSTEO-OUTCOME (NCT06737770)
- Testing
- osseointegrated surgery for transfemoral amputation
- Where
- Italy
- Volunteers
- 15 people
- Sponsor
- Istituto Ortopedico Rizzoli
Amputation With Osseointegration
Microbiome Population Adaptation Study
The investigators will accomplish our research aims by collecting cutaneous microbiome samples from 50 persons that have undergone the Osseointegration (OI) surgery at eight timepoints, prospectively.
- Trial name
- OLIMPAS (NCT06310239)
- Testing
- Collection of biologic samples and data
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Walter Reed National Military Medical Center
Amputation
Powered Prosthesis for Use With TF Osseointegration Recipients
The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR)…
- Trial name
- NCT06160882
- Testing
- Powered Prosthesis Training and EMG data collection, Perform Osseointegration (OI) surgery and Targeted Muscle Reinnervation (TMR)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Shirley Ryan AbilityLab
Amputation
Osseointegrated Transtibial Prosthesis With Neural Interface
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System.
- Trial name
- TTeOPRA (NCT05249049)
- Testing
- e-OPRA Implant System for Transtibial Amputees
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- Massachusetts Institute of Technology
Lower Extremity Amputation
Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years.
- Trial name
- AStrO-OI (NCT04934839)
- Testing
- Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.
- Where
- 2 sites in Italy
- Volunteers
- 8 people
- Sponsor
- Istituto Auxologico Italiano
Amputation
e-OPRA Implant System for Lower Limb Amputees
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System, approved under HDE (Humanitarian Device Exemption) H080004.
- Trial name
- NCT03720171
- Testing
- e-OPRA Implant System
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Integrum