SYNOSTE Nitinail System Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-12

Study Completion Date

2022-10-10

Brief Summary

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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.

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Detailed Description

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The SYNOSTE Nitinail System (SNS) is an assembly of an active implantable distraction nail (SYNOSTE Nitinail), Locking screws, accessory instruments for surgery and the home care unit (also External control unit (ECU) or Halo). It includes also, a software tool, Syndex, that supports setting up the number of lengthening activations needed per day.

The SNS is intended for lengthening of the femur by distraction osteogenesis.

The study will consist of a recruitment period of 3 months and an observation period of roughly 24 months (6 months after explantation). The observation period is split in two parts: The first part contains the most critical treatment phases from implantation surgery of the device through the actual lengthening phase up to the end of the bone healing. The second part contains only two visits: the explantation surgery of the device and a control at 6 months of further follow-up.

After the fist part of the trial, a primary analysis of the data including the hypothesis testing will be carried out. After the second part of the trial a follow-up analysis will be done.

16 (max 20) patients will be recruited in Finland and Turkey.

Conditions

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Leg Length Inequality

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SYNOSTE Nitinail System

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

Group Type EXPERIMENTAL

SYNOSTE Nitinail System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No