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SYNOSTE Nitinail System Trial

NCT03752814 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-03-09

No results posted yet for this study

Summary

SYNOSTE Nitinail System Trial is an international multicenter open label single-arm equivalence study to verify whether the leg-lengthening procedure can be adequately controlled with the SNS system as measured with the lengthening control index (LCI) at the end of the distraction period.

Conditions

  • Leg Length Inequality

Interventions

DEVICE

SYNOSTE Nitinail System

Mode of application: 1. Implantation surgery: osteotomy and antegrade implantation of SNS in femur for distraction osteogenesis (callotasis), 2. distraction osteogenesis (implant lengthening phase), 3. Bone healing (implant as stabilizing element during consolidation phase), 4. Explantation after consolidation.

Sponsors & Collaborators

  • MVZ Labor Dr. Limbach

    collaborator UNKNOWN

  • Technical University of Munich

    collaborator OTHER

  • SYNOSTE Oy

    lead INDUSTRY

Principal Investigators

  • Metin Küçükkaya, Prof. Dr. · Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey

  • Jan Lindahl, Dr. · HUCH Ortopedics and Traumatology, Töölö Hospital, Finland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-12
Primary Completion
2022-10-10
Completion
2022-10-10

Countries

  • Finland
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03752814 on ClinicalTrials.gov