Back to resultsCorrection of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device (PECA)
Primary Purpose
Hallux Valgus
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nexis® PECA Bunion device
Sponsored by
About this trial
This is an interventional other trial for Hallux Valgus
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.
Sites / Locations
- New Clinic Bel AirRecruiting
- Policlinic Bordeaux North Aquitaine
- Saint-Charles Clinic
- Toulouse University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hallux valgus correction
Arm Description
Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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
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
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05361317
Brief Title
Correction of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Acronym
PECA
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
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
February 13, 2024 (Anticipated)
Study Completion Date
August 13, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novastep
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hallux valgus correction
Arm Type
Other
Arm Description
Hallux valgus correction for all patients : intervention during intraoperative visit, with Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
Intervention Type
Device
Intervention Name(s)
Nexis® PECA Bunion device
Intervention Description
Hallux valgus correction with percutaneous chevron and Akin osteotomy.
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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
Description
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
Title
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)
Description
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
Title
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
Description
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
Title
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
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
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flora Peyret
Phone
+33 (0) 2 99 33 86 50
Email
flora.peyret@novastep-ortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Guiguen
Email
manon.guiguen@novastep-ortho.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc Girod
Organizational Affiliation
Novastep
Official's Role
Study Director
Facility Information:
Facility Name
New Clinic Bel Air
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jérémie KNAFO
Facility Name
Policlinic Bordeaux North Aquitaine
City
Bordeaux
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Saint-Charles Clinic
City
Lyon
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Toulouse University Hospital
City
Toulouse
Country
France
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Correction of Hallux Valgus With the Nexis® PECA Bunion Implantable Osteosynthesis Medical Device
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