Efficacy of Additional Osteotomies to Correct Hallux Valgus
Primary Purpose
Hallux Valgus
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
additional osteotomies
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus
Eligibility Criteria
Inclusion Criteria:
- Patient older than 18 years.
- Informed consent
Exclusion Criteria:
- Associated lesser metatarsals surgery.
- Associated surgery on midfoot, hindfoot or ankle.
- Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
- Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
- Patient who declined the study.
Sites / Locations
- Clinique Lille sud
- Clinique du Parc Lyon
- Clinique Mégival
- Clinique de l'Union
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
No additional osteotomy
varisation osteotomy addition
supination osteotomy addition
both (varisation + supination) osteotomies addition.
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
on weight bearing X-Rays
Secondary Outcome Measures
Recurrence of hallux valgus (HVA>20°).
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Mini 0 (Worse) - Maxi 100 (Better)
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Patient satisfaction (Likert scale)
very satisfied/satisfied/fairly satisfied/no satisfied
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04145882
Brief Title
Efficacy of Additional Osteotomies to Correct Hallux Valgus
Official Title
Is it Better to Add Supination Osteotomy, Varisation Osteotomy, or Both to Distal Chevron as Part of Hallux Valgus Management : a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 11, 2019 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
September 11, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan
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
Deviation of the big toe in valgus at the level of the first metatarsophalangeal joint is called Hallux Valgus. In case of significant pain especially due to a conflict with the shoes, surgery could be indicated. Angle between the first metatarsal (M1) and the first phalangeal (P1) is named Hallux Valgus Angle (HVA). Angle between M1 and the second metatarsal (M2) is named InterMetatarsal Angle (IMA). Angle between M1 distal articular surface and M1 shaft axis in a frontal plane is named Distal Metatarsal Articular Angle (DMAA).
Insufficient surgical correction is a risk factor of recurrence (HVA>20° after surgery). According to Okuda et al in a 67 patients group treated by proximal osteotomies correction, postoperative risk factors of recurrence at 33 month of follow-up are : HVA>40° before the surgery and HVA>15° with an IMA>10° 10 weeks (3-24) after the surgery.
Currently, one of the most common used procedure is a translated (laterally) distal chevron associated with a release of the metatarso-sesamoid suspensory ligament and a Akin procedure on P1. Nevertheless this procedure does not correct deformation in all plans. HVA and IMA are corrected but DMAA and M1 pronation angle are not.
Surgeons can add three different osteotomies in this type of chevron. In the dorsal saw cut a varisation wedge osteotomy is possible , in the plantar saw cut a supination wedge osteotomy is possible, and both are possible. No studies have tried to assess these three possibilities.
The investigators hypothesize that the addition of a varisation and/or a supination wedge osteotomies in a distal chevron decrease risk factors of recurrence at six months of follow-up
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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
515 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No additional osteotomy
Arm Type
Active Comparator
Arm Title
varisation osteotomy addition
Arm Type
Experimental
Arm Title
supination osteotomy addition
Arm Type
Experimental
Arm Title
both (varisation + supination) osteotomies addition.
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
additional osteotomies
Intervention Description
varisation osteotomy, supination osteotomy or both
Primary Outcome Measure Information:
Title
Rate of patients having both Hallux Valgus Angle >15° and InterMetatarsal Angle >10°
Description
on weight bearing X-Rays
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Recurrence of hallux valgus (HVA>20°).
Time Frame
5 years
Title
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Description
Mini 0 (Worse) - Maxi 100 (Better)
Time Frame
6 months
Title
American Orthopedic Foot and Ankle Forefoot Score (AOFAS)
Description
Mini 0 (Worse) - Maxi 100 (Better)
Time Frame
5 years
Title
Patient satisfaction (Likert scale)
Description
very satisfied/satisfied/fairly satisfied/no satisfied
Time Frame
6 months
Title
Patient satisfaction (Likert scale)
Description
very satisfied/satisfied/fairly satisfied/no satisfied
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient older than 18 years.
Informed consent
Exclusion Criteria:
Associated lesser metatarsals surgery.
Associated surgery on midfoot, hindfoot or ankle.
Neurologic diseases (Charcot Marie Tooth disease, poliomyelitis, compartment syndrome sequelae)
Clinical or X-ray degenerative signs (Hallux rigidus) or irreducible deformations (MTP1 arthrodesis indications).
Patient who declined the study.
Facility Information:
Facility Name
Clinique Lille sud
City
Lesquin
ZIP/Postal Code
59810
Country
France
Facility Name
Clinique du Parc Lyon
City
Lyon
ZIP/Postal Code
69006
Country
France
Facility Name
Clinique Mégival
City
Saint-Aubin-sur-Scie
ZIP/Postal Code
76550
Country
France
Facility Name
Clinique de l'Union
City
Saint-Jean
ZIP/Postal Code
31240
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Additional Osteotomies to Correct Hallux Valgus
We'll reach out to this number within 24 hrs