TerminatedNot Applicable

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

Stopped: Decision by the sponsor

United States, Switzerland100 participantsStarted 2020-10-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Baseline characteristics

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Type of surgery

Timeframe: Day of surgery until removal of the device (standard approximately 6 months)

Bone lengthening measurement

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Varus or valgus correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Rotational correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Ante- or retro-curvature correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Bone union / fusion assessment

Timeframe: removal of the device (standard approximately 6 months)

Trial details

NCT IDNCT04017065

SponsorAO Innovation Translation Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-11

View on ClinicalTrials.gov More Limb Deformities Congenital trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Baseline characteristics

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Type of surgery

Timeframe: Day of surgery until removal of the device (standard approximately 6 months)

Bone lengthening measurement

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Varus or valgus correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Rotational correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Ante- or retro-curvature correction assessment

Timeframe: baseline until the removal of the device (standard approximately 6 months)

Bone union / fusion assessment

Timeframe: removal of the device (standard approximately 6 months)