Ignite Creation Date:
2024-05-06 @ 12:42 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03824444
Status:
WITHDRAWN
Last Update Posted:
2024-01-26
First Post:
2019-01-17
Brief Title:
EFS Functional Expectations of Transhumeral Percutaneous OI Patients
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Functional Expectations of Transhumeral Percutaneous Osseointegration Patients
Status:
WITHDRAWN
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
End of funding and device in further development
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AEA PODS
Brief Summary:
An FDA Early Feasibility Study EFS allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data The Primary Aim of this proposal is to perform an FDA guided EFS of a percutaneous osseointegrated OI docking system for patients with transhumeral above elbow amputations establishing its initial safety Success of the Primary Aim Safety will be determined over a one year follow-up period by observing the rate of patients successfully using their device without removal The Secondary Aim of this proposal is to quantify the functional effectiveness of the OI device giving specific attention to protocol differences required for male and female patients Success for the Secondary Aim Functional Effectiveness will be to determine functional improvement with the device compared to the pre-operative performance This will be the first longitudinal analyses to evaluate the percutaneous OI devices on objective functionality measures of transhumeral amputation individuals
Detailed Description:
An FDA Early Feasibility Study EFS allows for early clinical evaluation of devices to provide proof of principle and initial clinical safety data Over the past four years the team has performed the first EFS clinical trial of a percutaneous osseointegrated OI docking system for patients with transfemoral amputations As of December 1 2017 10 transfemoral VA patients received the device and are ambulating successfully for up to 36-months with positive safety and functional results Currently the EFS safety and functionality data are being used to target a pivotal study of the transfemoral device to obtain Premarket Approval PMA that will result in the broad clinical introduction of the transfemoral OI device within the US However transhumeral patients are currently underserved by prosthetic technologies Nearly 60 of transhumeral patients limit their use of suspension-based prostheses and upwards of 30 of upper-limb suspension-type prosthetic devices are completely abandoned by both the VA and the military patient populations-with abandonment of the prosthesis most common among women The overarching goal of this proposal is to maximize the functional recovery of US Veteran military and civilian patients with transhumeral limb loss The investigators believe that this can be done by bringing FDA approved percutaneous OI devices to this patient population Over the past 3 years the investigators developed a unique percutaneous OI device known here as PODS specifically for transhumeral patients using an evidence based approach
The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for transhumeral patients establishing its initial clinical safety Transhumeral patients will be recruited to the Salt Lake City SLC VA for in-depth consultation and functional evaluation Recruited candidates will undergo a full clinical evaluation of the residual limb Functional assessments focusing on activities of daily living ADL and evaluation of joint and terminal device biomechanics will be collected with their socket-prosthetic device time 0 These data will be used for final patient selection N10 for inclusion in the FDA EFS clinical trial The EFS patients will be brought back to the SLC VA admitted to the hospital and have the Stage 1 surgery to receive the PODS endoprosthetic device and then discharged to home Approximately 4 weeks later patients will return to the SLC VA and have the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic device Post-operatively wound healing will be monitored at the percutaneous site Patients will be discharged from the hospital to continue outpatient rehabilitation Periodically time 3 6 and 12 months following the Stage 2 procedure patients will be brought back to the SLC VA for assessment of their residual bone soft tissues and device The functional assessments will be repeated with their PODS device at each follow-up visit Success of the Primary Aim Safety will be determined for the 1-year follow-up period with patients successfully using their PODS devices with no device removal due to deep bone infections aseptic loosening or atraumatic fracture
The Secondary Aim of this proposal is to quantify the functional effectiveness of the PODS device giving specific attention to protocol differences required for male and female patients Success for the Secondary Aim Functional Effectiveness will be to quantify the degree to which patients achieve functional improvement with the PODS device compared to the pre-operative performance These data will be the first longitudinal analyses to evaluate the impact of percutaneous OI prostheses on objective functionality measures of these transhumeral amputation individuals
The Primary Aim of this proposal is to perform an FDA guided EFS of the PODS device for transhumeral patients establishing its initial clinical safety Transhumeral patients will be recruited to the Salt Lake City SLC VA for in-depth consultation and functional evaluation Recruited candidates will undergo a full clinical evaluation of the residual limb Functional assessments focusing on activities of daily living ADL and evaluation of joint and terminal device biomechanics will be collected with their socket-prosthetic device time 0 These data will be used for final patient selection N10 for inclusion in the FDA EFS clinical trial The EFS patients will be brought back to the SLC VA admitted to the hospital and have the Stage 1 surgery to receive the PODS endoprosthetic device and then discharged to home Approximately 4 weeks later patients will return to the SLC VA and have the Stage 2 procedure performed to place the percutaneous post and attach their prosthetic device Post-operatively wound healing will be monitored at the percutaneous site Patients will be discharged from the hospital to continue outpatient rehabilitation Periodically time 3 6 and 12 months following the Stage 2 procedure patients will be brought back to the SLC VA for assessment of their residual bone soft tissues and device The functional assessments will be repeated with their PODS device at each follow-up visit Success of the Primary Aim Safety will be determined for the 1-year follow-up period with patients successfully using their PODS devices with no device removal due to deep bone infections aseptic loosening or atraumatic fracture
The Secondary Aim of this proposal is to quantify the functional effectiveness of the PODS device giving specific attention to protocol differences required for male and female patients Success for the Secondary Aim Functional Effectiveness will be to quantify the degree to which patients achieve functional improvement with the PODS device compared to the pre-operative performance These data will be the first longitudinal analyses to evaluate the impact of percutaneous OI prostheses on objective functionality measures of these transhumeral amputation individuals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None