Hallux ValgusPhase 1CO001NCT01879150
Pilot Study of CyclaPlex Implant, an Enhanced Suture and Button Implant Device in Hallux Valgus Deformity
A Phase 1 study testing Cyclaplex bone anchor in people with Hallux Valgus, run by Meir Medical Center at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Cyclaplex bone anchor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
MMC
Kfar Saba, 44281
Liraz Elazar, 0509291083, Liraz.Elazar@clalit.org.il
Elkahn Eleiv, MD, 0545900119, 'gibor5@gmail.com'
About this study
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
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
Read the 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 (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
- Conditions
- Hallux Valgus
- Being tested
- Cyclaplex bone anchor
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclaplex bone anchorDevice
Device implantation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cyclaplex bone anchor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
The AOFAS score results at each visit will be evaluated and compared to other known studies published
Measured: 6 months, 12 months
Pain and Functional assessment [Foot Function Index (FFI)]
Pain and functional index will be assesed for complete results and separately for pain and functionality
Measured: 6 months 12 months
Time to full weight bear, to use of regular shoes and fashion shoes.
Measured: 12 months
Reduction in 1st IMA from baseline to LOV
Measured: 6 months, 12 months
Number and type of Adverse Events
Adverse events will be evaluated for their severity and frequency
Measured: 6 months, 12 months
Complications at surgery
Number and type of complications at surgery will be evaluated
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elkahn Eliev, MD, Principal investigator, MMC orthopedic department physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879150
- Sponsor's protocol ID
- mmc-cyclaplex001-il
- Acronym
- CO001
- Status last verified
- Jun 2013
- First submitted
- 2 Sep 2012
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01879150
- Acronym / sponsor ID
- CO001 / mmc-cyclaplex001-il
- Conditions
- Hallux Valgus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 17 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 (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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYCLAPLEX bone anchors | Experimental | Device: Cyclaplex bone anchorFollowing 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclaplex bone anchorDevice implantation | Device | CYCLAPLEX bone anchors |
Primary outcome
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
6 secondary outcomes
General Improvement as assessed by American Orthopaedic Foot and Ankle Society Hallux Metatarsophalangeal-lnterphalangeal Scale (AOFAS HMIS) score
Time frame: 6 months, 12 months
Pain and Functional assessment [Foot Function Index (FFI)]
Time frame: 6 months 12 months
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
Complications at surgery
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elkahn Eliev, MD principal investigator
MMC orthopedic department physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclaplex bone anchor in people with Hallux Valgus, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2013.