SYNOSTE Nitinail System Trial

SYNOSTE

Status: Terminated

Conditions: Leg Length Inequality

Treatments: Device: SYNOSTE Nitinail System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03752814

01-2017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

SYNOSTE Nitinail System

Experimental group

Description:

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

Treatment:

Device: SYNOSTE Nitinail System