Clinical trial NCT05361317: Correction of Hallux Valgus with the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: Novastep
Sponsor class: INDUSTRY
First posted: 2022-05-04
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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.

Primary outcomes:
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
timeFrame: 6 months post-operative
Secondary outcomes:
measure: 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
timeFrame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
measure: 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
timeFrame: 3-4 months, 6 months and 2 years post-operative
measure: 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
timeFrame: 6 months and 2 years post-operative
measure: 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
timeFrame: 3-4 months, 6 months and 2 years post-operative
measure: 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)
timeFrame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
measure: 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
timeFrame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
measure: 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)
timeFrame: 6-8 weeks, 3-4 months, 6 months and 2 years post-operative
measure: 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
timeFrame: From inclusion visit (V0) to 2 years post-operative visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: New Clinic Bel Air
city: Bordeaux
country: France
facility: Policlinic Bordeaux North Aquitaine
city: Lyon
country: France
facility: Saint-Charles Clinic
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: Novastep
name: Loïc Girod
role: STUDY_DIRECTOR
References: