Status:
TERMINATED
SYNOSTE Nitinail System Trial
Lead Sponsor:
SYNOSTE Oy
Collaborating Sponsors:
MVZ Labor Dr. Limbach
Technical University of Munich
Conditions:
Leg Length Inequality
Eligibility:
All Genders
18-65 years
Phase:
NA
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 a...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03752814
Start Date
November 12 2018
End Date
October 10 2022
Last Update
March 9 2023
Active Locations (2)
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1
HUCH Ortopedics and Traumatology, Töölö Hospital
Helsinki, Uusimaa, Finland, 00260
2
Şişli Florence Nightingale Hospital, Şişli/İstanbul
Istanbul, Turkey (Türkiye)