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

NCT04017065 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-06-25

No results posted yet for this study

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.

Conditions

  • Limb Deformities Congenital
  • Limb Deformities Nos (Acquired)
  • Deformity of Bone

Interventions

DEVICE

DePuy Synthes MAXFRAMETM system

Patients treated with the MAXFRAMETM system will be followed up from before the surgery until the removal of the device. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.

Sponsors & Collaborators

  • AO Innovation Translation Center

    lead OTHER

Principal Investigators

  • Theodor F. Slongo, MD · University of Berne Children's Hospital Department of pediatric surgery

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-06-11
Completion
2021-06-11
FDA Device
Yes

Countries

  • United States
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017065 on ClinicalTrials.gov