Clinical Trial: Pilot Study of CyclaPlex Implant, an Enhanced Suture and Button Implant Device in Hallux Valgus Deformity

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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 for correction of inter-metatarsal angle in subjects suffering from mild to moderate Hallux Valgus deformity

Detailed Summary:

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.

Same as current

Current Secondary Outcome:

  • General Improvement as assessed by American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score [ Time Frame: 6 months, 12 months ]
    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 ]
    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 ]
  • Reduction in 1st IMA from baseline to LOV [ Time Frame: 6 months, 12 months ]
  • Number and type of Adverse Events [ Time Frame: 6 months, 12 months ]
    Adverse events will be evaluated for their severity and frequency
  • Complications at surgery [ Time Frame: 3 months ]
    Number and type of complications at surgery will be evaluated


Original Secondary Outcome: Same as current

Information By: Meir Medical Center

Dates:
Date Received: September 2, 2012
Date Started: June 2013
Date Completion: September 2014
Last Updated: June 13, 2013
Last Verified: June 2013