An interventional study of Nexis® PECA Bunion device in Hallux Valgus, sponsored by Novastep. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-07.
Sponsored by Novastep (part of Enovis) · Not applicable, Interventional, and Other
Among 17 studies in Hallux Valgus with a site in France — 3 open to participants now, 5 under way, none of them phase 3. Hallux Valgus · France.
Among the 17 studies in Hallux Valgus with a site in France, this one is the 6th largest by enrollment of the 13 interventional ones that give a count, is one of 3 that started in 2022, is one of 13 with no phase, and was the 13th registered.
157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.
Browse Hallux Valgus studies →3 of the 17 studies in Hallux Valgus with a site in France are open now. Recruiting first, the newest first:
Clinique Saint Jean, France · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
GCS Ramsay Santé pour l'Enseignement et la Recherche · Sites in France
Ages 18–85
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2022.
This study's enrollment of 86 is above the median of 58 across 119 interventional studies indexed under Hallux Valgus.
Median enrollment 74 across the 13 interventional studies, 76 across the 4 observational. Of the 12 that completed or were terminated, 2 (17%) have results posted.
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3 of 17 have an industry lead sponsor. The 10 most frequent:
This study is registered under Novastep, one of the names counted as Enovis. Under that name alone:
Novastep is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Enovis has 1 study filed under Hallux Valgus — fewer than ten, so there is no comparison to draw.
2 of the studies in Hallux Valgus with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06680518Clinique Saint Jean, FranceTourniquet Use in Hallux Valgus Surgery | 2026-11 |
| NCT07653828GCS Ramsay Santé pour l'Enseignement et la RechercheEvaluation of the Impact of Self-rehabilitation After Foot Surgery Via a Connected Application | 2026-12 |
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Among the 17 studies in Hallux Valgus with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Device: Nexis® PECA Bunion device
Hallux valgus correction with percutaneous chevron and Akin osteotomy.
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
Time frame: 6 months post-operative
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
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
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.
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
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
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
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
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)
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.
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
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.
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)
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.
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
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.
Time frame: From inclusion visit (V0) to 2 years post-operative visit
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Jan 2025, 31 months.
Of 56 interventional studies with no phase under Hallux Valgus, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 31 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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