Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System
Stopped early
Conditions studied: Limb Deformities Congenital, Limb Deformities Nos (Acquired), Deformity of Bone
In brief
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.
Key facts
- Study ID
- NCT04017065
- Run by
- AO Innovation Translation Center
- People needed
- 100
- Starts
- 2020-10-01
- Expected to finish
- 2021-06-11
- Last updated by the study team
- 2021-06-25
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Any patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system
- Informed consent obtained, i.e.:
- Ability to understand the content of the patient information/ICF
- Willingness and ability to participate in the clinical investigation according to the Registry Plan (RP)
- Signed and dated IRB/EC-approved written informed consent OR
- Written consent provided according to defined and IRB/EC approved procedures for patients who are not able to provide independent written informed consent
You may not qualify if…
- Participation in any other medical device or medicinal product study within the previous month that could influence the treatment observed in this registry
- Pregnancy
- Intraoperative decision to use another device than MAXFRAMETM
Where it is running
- Penn State Hershey Bone and Joint Institute — Hershey, Pennsylvania, United States
- University of Berne Children's Hospital Department of pediatric surgery — Bern, Schweiz, Switzerland
Full record on ClinicalTrials.gov
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