Status:
UNKNOWN
Pilot Study of CyclaPlex Implant, an Enhanced Suture and Button Implant Device in Hallux Valgus Deformity
Lead Sponsor:
Meir Medical Center
Conditions:
Hallux Valgus
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
Single center, open-label, single arm, pilot study designed to evaluate safety, tolerability and efficacy of CYCLAPLEX device, a minimal invasive enhanced suture and button implant and surgery tools f...
Detailed Description
INVESTIGATIONAL THERAPY Cycla Orthopedics Ltd has developed the CYCLAPLEX , a minimally invasive enhanced type of Suture and Button implant. It is intended to: (a) reduce the intermetatarsal angle (IM...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Adult males and female subjects, aged 20 to 75 years old, inclusive, at screening visit
- Subject weighing \<100 kg and body mass index (BMI) \<32 kg/m2
- Subjects with confirm diagnosis of HV deformity based on radiography assessment of IMA \> 12 º and less or equal to 20degree.
- Subjects who would need osteotomy of the 1st MT as part of their surgery.
- Able and willing to comply with the requirements of the protocol.
- Able to understand and sign written informed consent to participate in the study
- Exclusion criteria
- Contraindication to implantation procedure
- History of: Diabetes mellitus,Claudication vascular disease or known Peripheral Vascular Disease,Rheumatoid disease no palpable pulse (DP or PT),- Gout or any systemic inflammatory arthropathy,Osteoarthritis of first metatarsal,Neurological conditions associated with spasticity,No prior operation at 1st and 2nd Metatarsals
- Osteoporosis
- Secondary metatarsal complications including:Fracture (past or present), Aseptic necrosis or any deformity of 2nd MTH,Subject currently enrolled in or has not yet completed at least 30 days since ending
- Any condition that may jeopardize study participation (e.g. abnormal clinical or laboratory finding), the interpretation of study results or may impede the ability to obtain informed consent (e.g., mental condition)
Exclusion
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01879150
Start Date
June 1 2013
End Date
September 1 2014
Last Update
June 17 2013
Active Locations (1)
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1
MMC
Kfar Saba, Israel, 44281