Status:
TERMINATED
Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Limb Deformities Congenital
Limb Deformities Nos (Acquired)
Eligibility:
All Genders
Brief 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 c...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04017065
Start Date
October 1 2020
End Date
June 11 2021
Last Update
June 25 2021
Active Locations (2)
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1
Penn State Hershey Bone and Joint Institute
Hershey, Pennsylvania, United States, 17033-0850
2
University of Berne Children's Hospital Department of pediatric surgery
Bern, Schweiz, Switzerland, 3010