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Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System

2019-07-17 10:04:59 | BioPortfolio

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.

Study Design

Conditions

Limb Deformities Congenital

Intervention

DePuy Synthes MAXFRAMETM system

Location

Penn State Hershey Bone and Joint Institute
Hershey
Pennsylvania
United States
17033-0850

Status

Not yet recruiting

Source

AO Clinical Investigation and Documentation

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-07-17T10:04:59-0400

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Medical and Biotech [MESH] Definitions

Congenital structural deformities of the upper and lower extremities collectively or unspecified.

Deformity in which the foot is misaligned with respect to the TALUS in the ANKLE JOINT. While mostly congenital, as in CLUBFOOT, acquired deformities are included. Acquired talipedes are often associated with other foot deformities such as SYNDACTYLY and POLYDACTYLY.

Congenital structural abnormalities and deformities of the musculoskeletal system.

Congenital structural abnormalities of the UPPER EXTREMITY.

Congenital structural abnormalities of the LOWER EXTREMITY.

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