Limb Deformities CongenitalNCT04017065
Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System
An observational study of Limb Deformities Congenital and Limb Deformities Nos (Acquired), run by AO Innovation Translation Center at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Limb Deformities Congenital, Limb Deformities Nos (Acquired), Deformity of Bone
- What is being tested?
- DePuy Synthes MAXFRAMETM system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 11 Jun 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patients treated with the MAXFRAMETM system for congenital or acquired deformity correction.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Penn State Hershey Bone and Joint Institute
Hershey, Pennsylvania, 17033-0850
Switzerland1 site
University of Berne Children's Hospital Department of pediatric surgery
Bern, Schweiz, 3010
About this study
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.
Read the 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 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.
- Being tested
- DePuy Synthes MAXFRAMETM system
- Keywords
- limb deformity correction, limb lengthening, MAXFRAME system
- Medical subject headings
- Limb Deformities, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Synthes MAXFRAMETM systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with the MAXFRAMETM system | Any patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system Receives: Device: DePuy Synthes MAXFRAMETM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics
Demographics, medical history
Measured: baseline until the removal of the device (standard approximately 6 months)
Type of surgery
primary or revision surgery
Measured: Day of surgery until removal of the device (standard approximately 6 months)
Bone lengthening measurement
Bone lengthening (in mm)
Measured: baseline until the removal of the device (standard approximately 6 months)
Varus or valgus correction assessment
Varus or valgus correction (in degrees)
Measured: baseline until the removal of the device (standard approximately 6 months)
Rotational correction assessment
Rotational correction (in degrees)
Measured: baseline until the removal of the device (standard approximately 6 months)
Ante- or retro-curvature correction assessment
Ante- or retro-curvature correction (in degrees)
Measured: baseline until the removal of the device (standard approximately 6 months)
Bone union / fusion assessment
Bone union / fusion (in the case of an arthrodesis)
Measured: removal of the device (standard approximately 6 months)
Radiological assessments
Radiological assessment according to the measured anatomical angles (degree)
Measured: baseline until the removal of the device (standard approximately 6 months)
Radiological assessments of deformity parameters
deformity parameters depending on the level of the deformity (degree)
Measured: baseline until the removal of the device (standard approximately 6 months)
Reason for changes of treatment plan
reason for any treatment plan changes
Measured: baseline until the removal of the device (standard approximately 6 months)
End of deformity correction
Length gained (real (mm) according to the lengthened bone)
Measured: baseline until the removal of the device (standard approximately 6 months)
Assessment of the surgeon and patients experience with the MAXFRAME™ system
Survey with four questions to rate via numeric rating scale (0= not satisfied at all ; 10= totally satisfied)
Measured: removal of the device (standard approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Oct 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Why it stopped: Decision by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb Deformities CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- AO Innovation Translation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theodor F. Slongo, MD, Principal investigator, University of Berne Children's Hospital Department of pediatric surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017065
- Sponsor's protocol ID
- MAXFRAME
- Status last verified
- Aug 2020
- First submitted
- 17 Apr 2019
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Registry for Use of the MAXFRAME™ Multiaxial Correction System
- ClinicalTrials.gov ID
- NCT04017065
- Acronym / sponsor ID
- MAXFRAME
- Keywords
- limb deformity correction, limb lengthening, MAXFRAME system
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision by the sponsor
- Enrolment
- 100 participants (actual)
- Lead sponsor
- AO Innovation Translation CenterUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with the MAXFRAMETM system | – | Device: DePuy Synthes MAXFRAMETM systemAny patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patients treated with the MAXFRAMETM system for congenital or acquired deformity correction.
Key inclusion criteria (6 listed)
- Any patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system
- Informed consent obtained, i.e.:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DePuy Synthes MAXFRAMETM systemPatients 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. | Device | Patients treated with the MAXFRAMETM system |
Primary outcome
Baseline characteristics
Time frame: baseline until the removal of the device (standard approximately 6 months)
Demographics, medical history
Type of surgery
Time frame: Day of surgery until removal of the device (standard approximately 6 months)
primary or revision surgery
Bone lengthening measurement
Time frame: baseline until the removal of the device (standard approximately 6 months)
Bone lengthening (in mm)
Varus or valgus correction assessment
Time frame: baseline until the removal of the device (standard approximately 6 months)
Varus or valgus correction (in degrees)
Rotational correction assessment
Time frame: baseline until the removal of the device (standard approximately 6 months)
Rotational correction (in degrees)
Ante- or retro-curvature correction assessment
Time frame: baseline until the removal of the device (standard approximately 6 months)
Ante- or retro-curvature correction (in degrees)
Bone union / fusion assessment
Time frame: removal of the device (standard approximately 6 months)
Bone union / fusion (in the case of an arthrodesis)
Radiological assessments
Time frame: baseline until the removal of the device (standard approximately 6 months)
Radiological assessment according to the measured anatomical angles (degree)
Radiological assessments of deformity parameters
Time frame: baseline until the removal of the device (standard approximately 6 months)
deformity parameters depending on the level of the deformity (degree)
Reason for changes of treatment plan
Time frame: baseline until the removal of the device (standard approximately 6 months)
reason for any treatment plan changes
End of deformity correction
Time frame: baseline until the removal of the device (standard approximately 6 months)
Length gained (real (mm) according to the lengthened bone)
Assessment of the surgeon and patients experience with the MAXFRAME™ system
Time frame: removal of the device (standard approximately 6 months)
Survey with four questions to rate via numeric rating scale (0= not satisfied at all ; 10= totally satisfied)
Results and safety
The study was stopped early (reason given: Decision by the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodor F. Slongo, MD principal investigator
University of Berne Children's Hospital Department of pediatric surgery
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Deformities Congenital and Limb Deformities Nos (Acquired), run by AO Innovation Translation Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision by the sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics (time frame: baseline until the removal of the device (standard approximately 6 months)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2021.