TerminatedNot Applicable

SYNOSTE Nitinail System Trial

Stopped: Study was stopped due to administrative reasons.

Finland, Turkey (Türkiye)9 participantsStarted 2018-11-12

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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: * Indication for femoral lengthening from different etiologies of max. 70 mm at single lengthening * 18 to 65 years regardless of gender * Suitable anatomy for SNS * Able and willing to comply with study procedures Exclusion Criteria: * 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 * Need for osteotomies at multiple levels

What they're measuring

Lengthening control index (LCI)

Timeframe: 2,5 months

Trial details

NCT IDNCT03752814

SponsorSYNOSTE Oy

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-10

View on ClinicalTrials.gov More Leg Length Inequality trials