Pilot Study of CyclaPlex Implant, an Enhanced Suture and Button Implant Device in Hallux Valgus Deformity (CO001)
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 for correction of inter-metatarsal angle in subjects suffering from mild to moderate Hallux Valgus deformity
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Single Center, Open-label, Single Arm, Study Designed to Evaluate Safety, Tolerability and Efficacy of CyclaPlex Implant and Tools for Correction of First Inter-metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity|
- Percent of subjects with 1st IMA ≤9º or reduction of more than 7º in the 1st IMA compared to Base line at last observed value (LOV). [ Time Frame: 6 months follow up and 12 months follow up ] [ Designated as safety issue: No ]
- General Improvement as assessed by American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]The AOFAS score results at each visit will be evaluated and compared to other known studies published
- Pain and Functional assessment [Foot Function Index (FFI)] [ Time Frame: 6 months 12 months ] [ Designated as safety issue: Yes ]Pain and functional index will be assesed for complete results and separately for pain and functionality
- Time to full weight bear, to use of regular shoes and fashion shoes. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Reduction in 1st IMA from baseline to LOV [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
- Number and type of Adverse Events [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: Yes ]Adverse events will be evaluated for their severity and frequency
- Complications at surgery [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]Number and type of complications at surgery will be evaluated
- 1st intermetatarsal forces at time of implantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||September 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: CYCLAPLEX bone anchors
Following a 28-day screening period, eligible subjects requiring surgical correction for HV deformity (1st IMA >12degree, =<20 degree) will be enrolled to undergo HV deformity correction procedure with CYCLAPLEX under local or spinal anesthesia.
The device is implanted via small holes drilled in 1st and 2nd metatarsals. Complementary normal medical procedures such as bunionectomy, soft tissue release and HV angle correction will be performed as required.
Subjects will be followed-up for 50 weeks post-procedure.
Device: Cyclaplex bone anchor
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 (IMA) between 1MT and 2MT without osteotomy osteotomy b) reduce the risk of 2MT fractures (d) perform the implantation procedure in an easy and safe way.
The CYCLAPLEX predicated device is the "Suture and Button" type MiniTightrope. It is based on Mini Tightrope clinical experience, however with additional features to increase safety and functionality.
The CyclaPlex device comprise of two bone holders ('Anchors ') connected by a metal cord. The cord is connected to the buttons by crimp method as part of the surgery procedures The bone holders are T shape screws that are screwed into the bones after drilling holes across the 2 metatarsals. The gap in the bone as a result of the drilling is filled by the enhanced T shape buttons (screws). A nut is residing internally as part of the 1st met anchor structure. The IMA is reduced using specially designed tensioning tool CyclaPlex device is indicated for reducing intermetatarsal angles in cases where IMA is less than 200 eliminating the need for the traditional 1st metatarsal osteotomy. It used in conjunction with traditional release of the lateral MTP joint capsular structures and removal of the medial eminence as well as regular HVA reduction procedures such as AKIN.
The 2nd Metatarsal fracture risk is reduced due multiple/ accumulated factors:
(i) The hole drilled at 2nd metatarsal had been reduced significantly (ii) The hole is filled by conical screw and head. This firm anchoring method enable to distribute the horizontal forces applied during gate.
(iii) The metal screw type device enables bone growth over it and strengthen the bone at that area.
(iv) The connecting cord is housed inside the screw and has no direct touch with the bone, in both, 2nd and 1st metatarsals.
The device is delivered sterilized ( steam sterilization) double bag residing in cardboard box.
Dedicated assistive tools for multiple use are provided as well housed in a special tray intended for surgery room steam sterilization. The tools comprise of Aiming Drilling Guide,, screw driver for anchors insertion, Tensioning tool for reduction of the IMA, Crimping tool, cutter, single use drill bits
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879150
|Kfar Saba, Israel, 44281|
|Contact: Liraz Elazar 0509291083 Liraz.Elazar@clalit.org.il|
|Contact: Elkahn Eleiv, MD 0545900119 'firstname.lastname@example.org'|
|Sub-Investigator: Victor Feldman, MD|
|Sub-Investigator: Jonathan Koch, MD|
|Principal Investigator:||Elkahn Eliev, MD||MMC orthopedic department physician|