Clinical trial NCT03752814: SYNOSTE Nitinail System Trial
Official title: SYNOSTE Nitinail System Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Leg Length Inequality
Keywords: distraction osteogenesis
bone lengthening
leg length discrepancy
callotasis
Intramedullary distraction nail
Lead sponsor: SYNOSTE Oy
Sponsor class: INDUSTRY
Collaborators: name: MVZ Labor Dr. Limbach
name: Technical University of Munich
First posted: 2018-11-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lengthening control index (LCI)
timeFrame: 2,5 months
Secondary outcomes:
measure: Performance of Nitinail/Mechanical stability of Nitinail
timeFrame: 6-9 months
measure: Performance of Nitinail/Nitinail lengthening target achieved (%)
timeFrame: 2,5 months
measure: Performance of Nitinail/Nitinail lengthening target achieved (absolute value)
timeFrame: 2,5 months
measure: Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)
timeFrame: 2,5 months
measure: Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)
timeFrame: 2,5 months
measure: Performance of Nitinail/Retention of achieved length by Nitinail
timeFrame: 6-9 months
measure: Patient Reported Outcomes/Patient Satisfaction
timeFrame: 6-9 months AND 24 months
measure: Patient Reported Outcomes/Patient Satisfaction (aesthetic outcomes)
timeFrame: 6-9 months AND 24 months
measure: Patient Reported Outcomes/Change in scores of 36-Item Short Form Survey (SF-36)
timeFrame: 6-9 months AND 24 months
measure: Patient Reported Outcomes/Patient pain status
timeFrame: 2,5 months
measure: Patient Reported Outcomes/Patient pain status
timeFrame: 24 months
measure: Patient Reported Outcomes/Patient pain status (consumption of pain medication)
timeFrame: 24 months
measure: Patient Reported Outcomes/Length of sick leave due to treatment
timeFrame: 6-9 months AND 24 months
measure: Clinical Success of Treatment/Femur lengthening target achieved (%)
timeFrame: 6-9 months AND 24 months
measure: Clinical Success of Treatment/Femur lengthening target achieved (absolute value)
timeFrame: 6-9 months AND 24 months
measure: Clinical Success of Treatment/Weight bearing index
timeFrame: 6-9 months
measure: Clinical Success of Treatment/Consolidation index
timeFrame: 6-9 months
measure: Clinical Success of Treatment/Knee and hip joint Range of Motion (ROM)
timeFrame: 6-9 months AND 24 months
measure: Nitinail System Safety/Number and type of device related (Serious)Adverse Events
timeFrame: (6-9 months AND 24 months)
measure: Nitinail System Safety/Duration of surgery
timeFrame: 10 days and 18 months
measure: Nitinail System Safety/Length of hospital stay
timeFrame: 10 days and 18 months
measure: Nitinail System Safety/Patient compliance to lengthening protocol
timeFrame: 2,5 months
measure: Nitinail System Safety/Release of metallic ions from the Nitinail
timeFrame: 3 months/further monitoring up to 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUCH Ortopedics and Traumatology, Töölö Hospital
state: Uusimaa
city: Istanbul
country: Turkey
facility: Şişli Florence Nightingale Hospital, Şişli/İstanbul
Study officials:
affiliation: Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey
name: Metin Küçükkaya, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: HUCH Ortopedics and Traumatology, Töölö Hospital, Finland
name: Jan Lindahl, Dr.
role: PRINCIPAL_INVESTIGATOR
References: