Leg Length Inequality Clinical Trial
Official title:
SYNOSTE Nitinail System Trial
Verified date | March 2023 |
Source | SYNOSTE Oy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 9 |
Est. completion date | October 10, 2022 |
Est. primary completion date | October 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | HUCH Ortopedics and Traumatology, Töölö Hospital | Helsinki | Uusimaa |
Turkey | Sisli Florence Nightingale Hospital, Sisli/Istanbul | Istanbul |
Lead Sponsor | Collaborator |
---|---|
SYNOSTE Oy | MVZ Labor Dr. Limbach, Technical University of Munich |
Finland, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
2,5 months | |
Secondary | 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 | 6-9 months | |
Secondary | 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 | 2,5 months | |
Secondary | 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 | 2,5 months | |
Secondary | 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 | 2,5 months | |
Secondary | 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 | 2,5 months | |
Secondary | 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 | 6-9 months | |
Secondary | 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 | 6-9 months AND 24 months | |
Secondary | 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. | 6-9 months AND 24 months | |
Secondary | 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. | 6-9 months AND 24 months | |
Secondary | 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. | 2,5 months | |
Secondary | 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) | 24 months | |
Secondary | Patient Reported Outcomes/Patient pain status (consumption of pain medication) | Patient pain status as consumption of pain medication | 24 months | |
Secondary | 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 | 6-9 months AND 24 months | |
Secondary | 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 | 6-9 months AND 24 months | |
Secondary | 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 | 6-9 months AND 24 months | |
Secondary | 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) | 6-9 months | |
Secondary | 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) | 6-9 months | |
Secondary | 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 | 6-9 months AND 24 months | |
Secondary | 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. | (6-9 months AND 24 months) | |
Secondary | Nitinail System Safety/Duration of surgery | Duration of surgery of Nitinail related surgeries from cut-to- closure in minutes | 10 days and 18 months | |
Secondary | Nitinail System Safety/Length of hospital stay | Length of hospital stay of Nitinail related surgeries in days the patient spent in hospital perioperatively. | 10 days and 18 months | |
Secondary | 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. | 2,5 months | |
Secondary | 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. | 3 months/further monitoring up to 24 months |
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