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 range

18 Years – 65 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.