Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT04017065 |
Other study ID # |
MAXFRAME |
Secondary ID |
|
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
June 11, 2021 |
Study information
Verified date |
August 2020 |
Source |
AO Innovation Translation Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The aim of this international, prospective, multicenter case series (patient registry) is to
gather the first evidence on the use of the MAXFRAME™ system in normal clinical settings
during deformity correction of both, the upper and lower limb, and gain information on
indications, the handling of the device from the patients' and surgeons' perspective, as well
as number of re-planning needed.
It is planned to prospectively follow up to 100 patients treated with the MAXFRAME™ system.
Information on patients entered into the registry will be collected from before the surgery
until the removal of the device.
Description:
The newly developed MAXFRAME™ system from DePuy Synthes® is a multi-Axial correction system
based on the hexapod configuration. The indications for the MAXFRAME™ include, but are not
limited to, the treatment of open or closed fractures of long bones, pseudarthrosis, limb
lengthening via epiphyseal or metaphyseal distraction, joint arthrodesis, to bridge infected
fractures or non-unions, to correct bony or soft tissue deformities, and to correct of
segmental defects. One of the main novelties of this system is the Perspective Frame Matching
(PFM) technique. This software system uses the post-operative x-rays with the entire frame
mounted to the bone to generate a 3D visualization of the frame and the exact mounting
parameters as well as a representation of the deformity with regards to the position within
the frame. This system generates a treatment plan according to the exact representation of
the frame, and the deformity at the starting point of the correction. The risk of a frame
mal-positioning is reduced, which in return is believed to reduce the risk of a false
correction and hopefully leads to a more precise result. Further, this reduces the need for
adaptations to the initial treatment protocol, which require repeated radiological assessment
and may alienate the patient during the whole process of the deformity correction.
To the investigator's knowledge there are no published studies investigating the accuracy of
this method, therefore the aim of the proposed prospective multicenter registry is to gather
first evidence on the use of the MAXFRAME™ system in clinical settings and gain information
on indications, handling, the number of re-planning's needed, and treatment related adverse
events.
Up to 100 patients treated with the MAXFRAME™ system are planned to be included for two years
enrollment period. Each patient will be followed up from before the surgery until the removal
of the device.
All follow-up visits are according to standard of care. There are fixed time points (visits)
during a normal deformity correction process and follow-up:
- Baseline = pre-operative assessment
- Surgery = application of the frame (defined as day 0)
- Post-OP = post-operative image assessment (for PFM planning)
- Frame removal (including conversion, if applicable)
Further, there are additional time points (visits). An additional visit is defined as every
consultation during the deformity correction process, until the frame is removed, when a
registry specific event of interest occurs. The events of interest for additional visits are
the following:
- Re-plannings
- Re-operation / surgical interventions
- Changes to the frame
- Treatment related adverse event
- Deformity corrected
Following data points will be collected pre-, intra- and post-operatively:
Patients demographics, medical history and underlying diseases, Indication for the use of the
MAXFRAMETM system, Treatment goal(s), Treatment planning, Surgical details, Changes in
treatment plan, Frame removal, Radiological and calculated outcome assessment of the
deformity correction and/or lengthening, Treatment-related Adverse Events, Experience with
MAXFRAMETM system.