NCT03752814

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

November 16, 2018

Last Update Submit

March 7, 2023

Conditions

Leg Length Inequality

Keywords

distraction osteogenesisbone lengtheningleg length discrepancycallotasisIntramedullary distraction nail

Outcome Measures

Primary Outcomes (1)

  • Lengthening control index (LCI)

    The primary objective is 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 defined as LCI = DIachieved / DIscheduled ,where DIachieved = Achieved distraction index, ie. the daily rate of distraction has on average occurred during the lengthening phase in mm/d. DIscheduled = mean scheduled lengthening rate in mm/day. Analyzed at primary analysis.

    2,5 months

Secondary Outcomes (23)

  • Performance of Nitinail/Mechanical stability of Nitinail

    6-9 months

  • Performance of Nitinail/Nitinail lengthening target achieved (%)

    2,5 months

  • Performance of Nitinail/Nitinail lengthening target achieved (absolute value)

    2,5 months

  • Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)

    2,5 months

  • Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)

    2,5 months

  • +18 more secondary outcomes

Study Arms (1)

SYNOSTE Nitinail System

EXPERIMENTAL

The intended purpose of the SNS in this trial is lengthening of the femur by callotasis.

Device: SYNOSTE Nitinail System

Interventions

SYNOSTE Nitinail SystemDEVICE

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.

SYNOSTE Nitinail System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for femoral lengthening from different etiologies of max. 70 mm at single lengthening
  • to 65 years regardless of gender
  • Suitable anatomy for SNS
  • Able and willing to comply with study procedures

You may not qualify if:

  • Other electronic implants
  • Other Metallic implants in the affected limb below the osteotomy level
  • Need for Magnetic Resonance imaging during the study
  • BMI\>30kg/m2 or weight\>100kg
  • Smoker
  • Known hypersensitivity to Co, Ni, Cr or Ti metals
  • Known hypersensitivity to Poly-Ether-Ether-Ketone (PEEK) or Ultrahigh Molecular Weight Poly-Ethylene (UHMWPE)
  • Open growth plates
  • Malignancy or tumor in bone
  • Osteitis or soft tissue infection
  • Significant existing deficit in range of motion of the adjacent joints
  • Pseudoarthrosis
  • Pregnancy
  • Low psychological compliance (e.g. drug abuse)
  • Simultaneous bilateral lengthening
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HUCH Ortopedics and Traumatology, Töölö Hospital

Helsinki, Uusimaa, 00260, Finland

Location

Şişli Florence Nightingale Hospital, Şişli/İstanbul

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Leg Length Inequality

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Metin Küçükkaya, Prof. Dr.

    Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey

    PRINCIPAL INVESTIGATOR

  • Jan Lindahl, Dr.

    HUCH Ortopedics and Traumatology, Töölö Hospital, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2018

First Posted

November 26, 2018

Study Start

November 12, 2018

Primary Completion

October 10, 2022

Study Completion

October 10, 2022

Last Updated

March 9, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)TU(1)