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

NCT04017065 | Terminated FDA Device

• 1 other identifier: MAXFRAME
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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 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

Keywords

limb deformity correction; limb lengthening; MAXFRAME system

Outcome Measures

Primary Outcomes (12)

• Baseline characteristics

  Demographics, medical history

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

• Type of surgery

  primary or revision surgery

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

• Bone lengthening measurement

  Bone lengthening (in mm)

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

• Varus or valgus correction assessment

  Varus or valgus correction (in degrees)

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

• Rotational correction assessment

  Rotational correction (in degrees)

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

• Ante- or retro-curvature correction assessment

  Ante- or retro-curvature correction (in degrees)

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

• Bone union / fusion assessment

  Bone union / fusion (in the case of an arthrodesis)

  removal of the device (standard approximately 6 months)

• Radiological assessments

  Radiological assessment according to the measured anatomical angles (degree)

  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)

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

• Reason for changes of treatment plan

  reason for any treatment plan changes

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

• End of deformity correction

  Length gained (real (mm) according to the lengthened bone)

  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)

  removal of the device (standard approximately 6 months)

Study Arms (1)

Patients treated with the MAXFRAMETM system

Any patient undergoing surgical treatment (primary or revision) for deformity correction using the MAXFRAME™ system

Device: DePuy Synthes MAXFRAMETM system

Interventions

DePuy Synthes MAXFRAMETM system DEVICE

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.

Patients treated with the MAXFRAMETM system

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patients treated with the MAXFRAMETM system for congenital or acquired deformity correction.

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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (2)

Penn State Hershey Bone and Joint Institute

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Berne Children's Hospital Department of pediatric surgery

Bern, Schweiz, 3010, Switzerland

Location

MeSH Terms

Conditions

Limb Deformities, Congenital

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Theodor F. Slongo, MD

  University of Berne Children's Hospital Department of pediatric surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: July 12, 2019
• Study Start: October 1, 2020
• Primary Completion: June 11, 2021
• Study Completion: June 11, 2021
• Last Updated: June 25, 2021

Record last verified: 2020-08

Locations

US (1); CH (1)