Hallux ValgusPECANCT05361317
Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
A study testing Nexis® PECA Bunion device in people with Hallux Valgus, run by Novastep at 4 sites in France.
Trial summary
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices. The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Nexis® PECA Bunion device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 4 sitesFrance
- Study dates
- 13 Jun 2022to 13 Jun 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a hallux valgus foot pathology requiring correction
- First line operation
- Use of the medical device concerned PECA Bunion
- Unilateral operation
- Patient aged 18 or over
- Isolated hallux valgus correction, without associated surgical procedures
Show all 9Show fewer
- Patient able to respect the prescriptions and recommendations of his surgeon
- Patient able to read and understand the information note on the objectives of the study and the collection of their data
- Patient able to sign a consent form
Who cannot join
- Patient with a contraindication to the device under investigation,
- Simultaneous participation in another clinical investigation protocol,
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.
Trial locations and contacts
4 sites in 1 country.
France4 sites
New Clinic Bel Air
Bordeaux
Policlinic Bordeaux North Aquitaine
Bordeaux
Saint-Charles Clinic
Lyon
Toulouse University Hospital
Toulouse
About this study
Official title: Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.
The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.
- Conditions
- Hallux Valgus
- Being tested
- Nexis® PECA Bunion device
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexis® PECA Bunion deviceDevice
Hallux valgus correction with percutaneous chevron and Akin osteotomy.
| Study group | Role | What they receive |
|---|---|---|
| Hallux valgus correction | Other | Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device Receives: Device: Nexis® PECA Bunion device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of the patient's foot, with the evaluation of the "general sub-score" of the European Foot and Ankle Society (EFAS) questionnaire during post-operative visit at 6 months.
The questionnaire collects information on the following categories: functional capacity of the patient's foot in general (6 items), and functional capacity of the patient's foot during sport (4 items).
The scores to be calculated range from 0-4 per question, 0-24 for the general category (the only category to be evaluated for the primary outcome).
A score of 0 indicates the worst possible foot/ankle symptoms and 24 indicates no symptoms foot/ankle.
In this study, an objective score of 16 (out of a total of 24) was determined
Measured: 6 months post-operative
Secondary outcomes (8)
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters with the evaluation of the evolution of the pain with Visual Analog Scale
The VAS (Visual Analog Scale) score is a tool used to measure pain ranging from 0 (no pain) to 10 (very intense pain).
An evolution of 4.63 is expected between preoperative visit and postoperative visits
Measured: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with evaluation of clinical parameters: evaluation of the evolution of the quality of life with American Orthopedic Foot and Ankle Scale
The American Orthopedic Foot and Ankle Score (AOFAS) combines subjective pain and function scores provided by the patient and objective scores based on the physician's physical examination. The questionnaire is composed of nine items, divided into three categories: pain, functional aspects and alignment, resulting in a total score of 100 points. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
An improvement of 26.87 in the AOFAS score is expected at postoperative visits compared to preoperative visit.
Measured: 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters : evaluation of the evolution of the quality of life with The Short Form (36) Health Survey
The Short Form (36) Health Survey is a standardized auto-questionnaire for measuring quality of life. The questionnaire is made up of 36 questions, divided into 8 dimensions: physical activity, life and relationships with others, physical pain, perceived general health, vitality, limitations due to mental state, limitations due to physical state, mental health.
SF-36 is a 0-100 scale : a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
An improvement of 3.6 in the SF-36 score is expected at postoperative visits compared to preoperative visit
Measured: 6 months and 2 years post-operative
Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of clinical parameters: evaluation of functionality of the foot in sport with "sub-score sport" of the European Foot and Ankle Society scale
The sport sub-score of the European Foot and Ankle Society (EFAS) questionnaire is used to measure the functional capacity of the patient's foot during sports practice and ranges from 0 to 16 for the sport category, with a score of 0 indicating the worst possible foot/ankle symptoms and 16 indicating no foot/ankle symptoms.
An improvement of 4.7 in the sub-score "sport" of the EFAS is expected at postoperative visits
Measured: 3-4 months, 6 months and 2 years post-operative
Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of radiographics parameters: evaluation of evolution of angular measures (hallux valgus, Inter-metatarsal and Distal Metaphyseal Articular Angles)
Hallux valgus angle (HVA), Inter-metatarsal angle (IMA) and Distal Metaphyseal Articular Angle (DMAA) are calculated with radiography.
The expected angle correction is a reduction of 7.60° for HVA, 4° for IMA and 5.50° for DMAA at 6 months and 2 years postoperative.
Measured: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of radiographics parameters (X-rays) with the evaluation of evolution of consolidation
The evaluation of bone consolidation on x-rays will be carried out by the surgeon. The presence of bone consolidation at a rate greater than or equal to 90% should be demonstrated at 6-8 weeks, 3-4 months, 6 months and 2 years postoperatively.
Measured: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters thanks to the evaluation of mobility (dorsiflexion and plantar flexion)
Description and comparison of:
Dorsiflexion mobility at V2 (6-8 weeks), V3 (3-4 months), 6 months (V4) and at 2 years (V5) compared to V0 : A mobility greater than or equal to 57.35° is expected.
and Mobility in plantar flexion at V2 (6-8 weeks), V3 (3-4 months), 6 months (V4) and at 2 years (V5) compared to V0 : A mobility of 24.85° is expected.
Measured: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the safety of the device under investigation for the correction of hallux valgus by evaluating the occurrence of adverse events, complications and device defects
The occurrence of adverse events (including complications) and defects will be assessed intraoperatively and at each postoperative visit by questioning the patient, clinical and radiographic examinations.
Measured: From inclusion visit (V0) to 2 years post-operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start13 Jun 2022
- Primary completion15 Jan 2025
- Study completion13 Jun 2026 (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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novastep
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Loïc Girod, Study director, Novastep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361317
- Sponsor's protocol ID
- 2022-1
- Acronym
- PECA
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device : Evaluation of Quality of Life Scores, Angular Correction, Bone Consolidation and Occurrence of Adverse Events
- ClinicalTrials.gov ID
- NCT05361317
- Acronym / sponsor ID
- PECA / 2022-1
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (actual)
- Lead sponsor
- NovastepIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 13 Jun 2026 (estimated)
- First posted
- 4 May 2022 (actual)
- 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.
The Nexis® screw system is a range of osteosynthesis screws for the foot. Nexis® Bunion Screws are Class IIb implantable medical devices.
The primary objective of the study is to confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation functional capacities of the patient's foot. It will be assessed with "general sub-score" of the EFAS questionnaire determined during the postoperative visit at 6 months.
The evaluation of quality of life scores, angular correction, bone consolidation and occurrence of adverse events will also be carried out.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hallux valgus correction | Other | Device: Nexis® PECA Bunion deviceHallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with a hallux valgus foot pathology requiring correction
- First line operation
- Use of the medical device concerned PECA Bunion
- Unilateral operation
- Patient aged 18 or over
Key exclusion criteria (3 listed)
- Patient with a contraindication to the device under investigation,
- Simultaneous participation in another clinical investigation protocol,
- Adults subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty, pregnant or breastfeeding women, minors.
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 |
|---|---|---|
| Nexis® PECA Bunion deviceHallux valgus correction with percutaneous chevron and Akin osteotomy. | Device | Hallux valgus correction |
Primary outcome
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale
Time frame: 6 months post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of the patient's foot, with the evaluation of the "general sub-score" of the European Foot and Ankle Society (EFAS) questionnaire during post-operative visit at 6 months. The questionnaire collects information on the following categories: functional capacity of the patient's foot in general (6 items), and functional capacity of the patient's foot during sport (4 items). The scores to be calculated range from 0-4 per question, 0-24 for the general category (the only category to be evaluated for the primary outcome). A score of 0 indicates the worst possible foot/ankle symptoms and 24 indicates no symptoms foot/ankle. In this study, an objective score of 16 (out of a total of 24) was determined
8 secondary outcomes
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters with the evaluation of the evolution of the pain with Visual Analog Scale
Time frame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus with evaluation of clinical parameters: evaluation of the evolution of the quality of life with American Orthopedic Foot and Ankle Scale
Time frame: 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters : evaluation of the evolution of the quality of life with The Short Form (36) Health Survey
Time frame: 6 months and 2 years post-operative
Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of clinical parameters: evaluation of functionality of the foot in sport with "sub-score sport" of the European Foot and Ankle Society scale
Time frame: 3-4 months, 6 months and 2 years post-operative
Confirm performance and effectiveness of the device for the correction of hallux valgus with the evaluation of radiographics parameters: evaluation of evolution of angular measures (hallux valgus, Inter-metatarsal and Distal Metaphyseal Articular Angles)
Time frame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of radiographics parameters (X-rays) with the evaluation of evolution of consolidation
Time frame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the performance and effectiveness of the device under investigation for the correction of hallux valgus with the evaluation of clinical parameters thanks to the evaluation of mobility (dorsiflexion and plantar flexion)
Time frame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
Confirm the safety of the device under investigation for the correction of hallux valgus by evaluating the occurrence of adverse events, complications and device defects
Time frame: From inclusion visit (V0) to 2 years post-operative visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Loïc Girod study director
Novastep
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexis® PECA Bunion device in people with Hallux Valgus, run by Novastep at 4 sites in France.
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 9 inclusion and 3 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm performance and effectiveness of the device under investigation for the correction of hallux valgus in terms of functional capacities of patient's foot determined thanks to the "general sub-score" of the European Foot and Ankle Society scale (time frame: 6 months post-operative). 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 7 Mar 2025.