Leg Length InequalityNCT03752814
SYNOSTE Nitinail System Trial
A study testing SYNOSTE Nitinail System in people with Leg Length Inequality, run by SYNOSTE Oy at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leg Length Inequality
- What is being tested?
- SYNOSTE Nitinail System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Nov 2018to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site
HUCH Ortopedics and Traumatology, Töölö Hospital
Helsinki, Uusimaa, 00260
Turkey (Türkiye)1 site
Şişli Florence Nightingale Hospital, Şişli/İstanbul
Istanbul
About this study
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.
Read the 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.
- Conditions
- Leg Length Inequality
- Being tested
- SYNOSTE Nitinail System
- Keywords
- distraction osteogenesis, bone lengthening, leg length discrepancy, callotasis, Intramedullary distraction nail
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYNOSTE Nitinail SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SYNOSTE Nitinail System | Experimental | The intended purpose of the SNS in this trial is lengthening of the femur by callotasis. Receives: Device: SYNOSTE Nitinail System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lengthening control index (LCI)
The primary objective is 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 defined as LCI = DIachieved / DIscheduled
,where DIachieved = Achieved distraction index, ie. the daily rate of distraction has on average occurred during the lengthening phase in mm/d. DIscheduled = mean scheduled lengthening rate in mm/day.
Analyzed at primary analysis.
Measured: 2,5 months
Secondary outcomes (23)
Performance of Nitinail/Mechanical stability of Nitinail
Mechanical stability of Nitinail as defined by the ratio of the numbers of breakages (nail and screws) to total nails implanted (% and absolute values) at the end of consolidation
Measured: 6-9 months
Performance of Nitinail/Nitinail lengthening target achieved (%)
Nitinail lengthening target achieved as defined by % of targeted lengthening achieved by Nitinail determined at the end of lengthening period
Measured: 2,5 months
Performance of Nitinail/Nitinail lengthening target achieved (absolute value)
Nitinail lengthening target achieved as defined by absolute value of targeted lengthening achieved by Nitinail determined at the end of lengthening period
Measured: 2,5 months
Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)
Translation of nail lengthening to bone lengthening as % of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period
Measured: 2,5 months
Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)
Translation of nail lengthening to bone lengthening as absolute value of the Bone gap increase from achieved lengthening of Nitinail determined at the end of lengthening period
Measured: 2,5 months
Performance of Nitinail/Retention of achieved length by Nitinail
Retention of achieved length by Nitinail as change of achieved lengthening of Nitinail between end of distraction and end of consolidation
Measured: 6-9 months
Patient Reported Outcomes/Patient Satisfaction
Patient satisfaction as the overall satisfaction value from Numeric Rating Scale at end of consolidation and final follow-up. The NRS for overall outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their overall satisfaction with the treatment outcomes on a horizontal line. "0" represents completely dissatisfied and "10" fully satisfied
Measured: 6-9 months AND 24 months
Patient Reported Outcomes/Patient Satisfaction (aesthetic outcomes)
Patient satisfaction as the aesthetic outcomes value from Numeric Rating Scale (NRS) at end of consolidation and final follow-up. The NRS for aesthetic outcomes is a undimensional measure of satisfaction intensity, where the patient selects among 0-10 integers to describe the intensity of their satisfaction with the aesthetic outcomes on a horizontal line. "0" represents completely dissatisfied and "10" fully satisfied.
Measured: 6-9 months AND 24 months
Patient Reported Outcomes/Change in scores of 36-Item Short Form Survey (SF-36)
Change in scores of SF-36 from preoperative baseline to end of consolidation for Primary analysis and to last visit for the Follow-up analysis. The used version of the SF-36 is the RAND 36-item health survey 1.0 (1993) with a time frame of 4 weeks. The SF-36 is an established and widely used set of generic, coherent, and easily administered quality-of-life measures in adults. Scoring will be done according to the instructions provided by RAND. Single item scores as well as health concept scale scores range from 0 to 100. A higher score defines a more favorable health state, with a value of 100 representing full health.
Measured: 6-9 months AND 24 months
Patient Reported Outcomes/Patient pain status
Patient pain status as change of Numeric Rating Scale (NRS) from preoperative baseline to End of distraction (2,5 months). The NRS for pain is a undimensional measure of pain intensity, where the patient selects among 0-10 integers to describe the intensity of their pain on a horizontal line. "0" represents no pain and "10" worst possible pain.
Measured: 2,5 months
Patient Reported Outcomes/Patient pain status
Patient pain status as the pain profile of the Numeric Rating Scale (as described above) during the treatment (until 24 months)
Measured: 24 months
Patient Reported Outcomes/Patient pain status (consumption of pain medication)
Patient pain status as consumption of pain medication
Measured: 24 months
Patient Reported Outcomes/Length of sick leave due to treatment
Length of sick leave due treatment in days assessed until the end of consolidation and end of treatment for Primary and Follow-up analyses, respectively
Measured: 6-9 months AND 24 months
Clinical Success of Treatment/Femur lengthening target achieved (%)
Femur lengthening target achieved as % of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses
Measured: 6-9 months AND 24 months
Clinical Success of Treatment/Femur lengthening target achieved (absolute value)
Femur lengthening target achieved as absolute value of the achieved femoral length increase of the targeted femoral length increase in mm determined at the end of consolidation and end of treatment for Primary and Follow-up analyses
Measured: 6-9 months AND 24 months
Clinical Success of Treatment/Weight bearing index
Weight bearing index as time to final full weight bearing (in days) per the achieved femoral length increase (in cm)
Measured: 6-9 months
Clinical Success of Treatment/Consolidation index
Consolidation index as time to radiological confirmation of 3 cortices bridging the bony gap (in days) per the achieved femoral length increase (in cm)
Measured: 6-9 months
Clinical Success of Treatment/Knee and hip joint Range of Motion (ROM)
Knee and hip joint Range of Motion (ROM) as flexion and extension at preoperative baseline, End of distraction and End of consolidation and compared to normal population values
Measured: 6-9 months AND 24 months
Nitinail System Safety/Number and type of device related (Serious)Adverse Events
Number and type of device related (Serious)Adverse Events reported until the end of consolidation and end of treatment.
Measured: (6-9 months AND 24 months)
Nitinail System Safety/Duration of surgery
Duration of surgery of Nitinail related surgeries from cut-to- closure in minutes
Measured: 10 days and 18 months
Nitinail System Safety/Length of hospital stay
Length of hospital stay of Nitinail related surgeries in days the patient spent in hospital perioperatively.
Measured: 10 days and 18 months
Nitinail System Safety/Patient compliance to lengthening protocol
Patient compliance to lengthening protocol as ratio of lengthening periods with non- compliance to protocol with all lengthening periods with one patient.
Measured: 2,5 months
Nitinail System Safety/Release of metallic ions from the Nitinail
Release of metallic ions from the Nitinail as Cobalt and Chromium ion concentrations in blood from preoperative baseline to end of distraction.
Measured: 3 months/further monitoring up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start12 Nov 2018
- Primary completion10 Oct 2022
- Study completion10 Oct 2022
Why it stopped: Study was stopped due to administrative reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg Length InequalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- SYNOSTE Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MVZ Labor Dr. Limbach, Technical University of Munich
- Responsible party
- Sponsor
- Investigators
- Metin Küçükkaya, Prof. Dr., Principal investigator, Şişli Florence Nightingale Hospital, Şişli/İstanbul, TurkeyJan Lindahl, Dr., Principal investigator, HUCH Ortopedics and Traumatology, Töölö Hospital, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752814
- Sponsor's protocol ID
- 01-2017
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2018
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYNOSTE Nitinail System Trial
- ClinicalTrials.gov ID
- NCT03752814
- Acronym / sponsor ID
- 01-2017
- Conditions
- Leg Length Inequality
- Keywords
- distraction osteogenesis, bone lengthening, leg length discrepancy, callotasis, Intramedullary distraction nail
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to administrative reasons.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SYNOSTE OyIndustry (pharma, biotech, devices)
- Collaborators
- MVZ Labor Dr. Limbach, Technical University of Munich
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 26 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYNOSTE Nitinail System | Experimental | Device: SYNOSTE Nitinail SystemThe intended purpose of the SNS in this trial is lengthening of the femur by callotasis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYNOSTE Nitinail SystemMode 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. | Device | SYNOSTE Nitinail System |
Primary outcome
Lengthening control index (LCI)
Time frame: 2,5 months
The primary objective is 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 defined as LCI = DIachieved / DIscheduled ,where DIachieved = Achieved distraction index, ie. the daily rate of distraction has on average occurred during the lengthening phase in mm/d. DIscheduled = mean scheduled lengthening rate in mm/day. Analyzed at primary analysis.
23 secondary outcomes
Performance of Nitinail/Mechanical stability of Nitinail
Time frame: 6-9 months
Performance of Nitinail/Nitinail lengthening target achieved (%)
Time frame: 2,5 months
Performance of Nitinail/Nitinail lengthening target achieved (absolute value)
Time frame: 2,5 months
Performance of Nitinail/Translation of nail lengthening to bone lengthening (%)
Time frame: 2,5 months
Performance of Nitinail/Translation of nail lengthening to bone lengthening (absolute value)
Time frame: 2,5 months
Performance of Nitinail/Retention of achieved length by Nitinail
Time frame: 6-9 months
Patient Reported Outcomes/Patient Satisfaction
Time frame: 6-9 months AND 24 months
Patient Reported Outcomes/Patient Satisfaction (aesthetic outcomes)
Time frame: 6-9 months AND 24 months
Patient Reported Outcomes/Change in scores of 36-Item Short Form Survey (SF-36)
Time frame: 6-9 months AND 24 months
Patient Reported Outcomes/Patient pain status
Time frame: 2,5 months
Patient Reported Outcomes/Patient pain status
Time frame: 24 months
Patient Reported Outcomes/Patient pain status (consumption of pain medication)
Time frame: 24 months
Patient Reported Outcomes/Length of sick leave due to treatment
Time frame: 6-9 months AND 24 months
Clinical Success of Treatment/Femur lengthening target achieved (%)
Time frame: 6-9 months AND 24 months
Clinical Success of Treatment/Femur lengthening target achieved (absolute value)
Time frame: 6-9 months AND 24 months
Clinical Success of Treatment/Weight bearing index
Time frame: 6-9 months
Clinical Success of Treatment/Consolidation index
Time frame: 6-9 months
Clinical Success of Treatment/Knee and hip joint Range of Motion (ROM)
Time frame: 6-9 months AND 24 months
Nitinail System Safety/Number and type of device related (Serious)Adverse Events
Time frame: (6-9 months AND 24 months)
Nitinail System Safety/Duration of surgery
Time frame: 10 days and 18 months
Nitinail System Safety/Length of hospital stay
Time frame: 10 days and 18 months
Nitinail System Safety/Patient compliance to lengthening protocol
Time frame: 2,5 months
Nitinail System Safety/Release of metallic ions from the Nitinail
Time frame: 3 months/further monitoring up to 24 months
Results and safety
The study was stopped early (reason given: Study was stopped due to administrative reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Leg Length Inequality
Not yet recruiting
Acute Effect of Standardized Ankle Taping on Lower Limb Asymmetry During Countermovement Jump in Healthy Judokas
Ankle Stability
RecruitingObservational study
Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics
Lower Limb Length Discrepancy (LLD) in Children
RecruitingObservational study
Study to Assess the Pain, Satisfaction, and Quality of Life of Patients With FITBONE® Lengthening Nail
Leg Length Inequality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Metin Küçükkaya, Prof. Dr. principal investigator
Şişli Florence Nightingale Hospital, Şişli/İstanbul, Turkey
Jan Lindahl, Dr. principal investigator
HUCH Ortopedics and Traumatology, Töölö Hospital, Finland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYNOSTE Nitinail System in people with Leg Length Inequality, run by SYNOSTE Oy at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped due to administrative reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lengthening control index (LCI) (time frame: 2,5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.