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

NCT01879150 | Unknown Phase 1

• 1 other identifier: mmc-cyclaplex001-il
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months follow up and 12 months follow up

Secondary Outcomes (6)

• General Improvement as assessed by American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score

  6 months, 12 months

• Pain and Functional assessment [Foot Function Index (FFI)]

  6 months 12 months

• Time to full weight bear, to use of regular shoes and fashion shoes.

  12 months

• Reduction in 1st IMA from baseline to LOV

  6 months, 12 months

• Number and type of Adverse Events

  6 months, 12 months

Other Outcomes (1)

• 1st intermetatarsal forces at time of implantation

  3 months

Study Arms (1)

CYCLAPLEX bone anchors

EXPERIMENTAL

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

Interventions

Cyclaplex bone anchor DEVICE

Device implantation

CYCLAPLEX bone anchors

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

MMC

Kfar Saba, 44281, Israel

RECRUITING

MeSH Terms

Conditions

Hallux Valgus

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Study Officials

• Elkahn Eliev, MD

  MMC orthopedic department physician

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2012
• First Posted: June 17, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

IL (1)