Health Condition 1: M201- Hallux valgus (acquired)
Conditions
Interventions
Intervention1: Dual-Fulcrum Hallux Valgus Dynamic Splint with Medial Arch Raise: Participants diagnosed with mild to moderate hallux valgus deformity will be provided with a dual-fulcrum dynamic hallu
Sponsors
Kruthikaa Rajindran
Eligibility
Inclusion criteria
Inclusion criteria: Mild to moderate hallux valgus with Hallux Valgus Angle 15 to 40 degree and Intermetatarsal Angle 9 to 16 degree Symptomatic patients with pain discomfort or footwear difficulty attributable to hallux valgus Flexible deformity with preserved first metatarsophalangeal joint motion Independent ambulation Willingness to comply with the prescribed dual fulcrum dynamic hallux valgus splint with medial arch raise as advised Ability to comply with study protocol and follow up schedule
Exclusion criteria
Exclusion criteria: Severe hallux valgus with Hallux Valgus Angle more than 40 degree and Intermetatarsal Angle 16 to 20 degree Previous surgical intervention involving the first ray or forefoot Rigid deformity or fixed first metatarsophalangeal joint Presence of inflammatory arthropathy like rheumatoid arthritis or seronegative spondyloarthropathy Neuromuscular disorders affecting foot posture or gait Significant degenerative arthritis of the first metatarsophalangeal joint Active skin infection or ulceration or dermatological condition preventing splint application Peripheral neuropathy or loss of protective sensation Pregnancy Inability or unwillingness to adhere to splint usage or follow up protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is radiographic correction of hallux valgus, assessed by the change in Hallux Valgus Angle (HVA) on weight-bearing anteroposterior foot radiographs. Measurements will be recorded at baseline and at 6 months following initiation of the dual-fulcrum dynamic hallux valgus splint with medial arch raise.Timepoint: Baseline, 6 weeks, 3 months, and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include change in Intermetatarsal Angle (IMA), pain severity assessed using the Visual Analogue Scale (VAS), functional outcome assessed using the AOFAS Hallux-MTP-IP score and Foot Function Index (FFI), and patient compliance measured as average daily splint usage (hours per day). Secondary outcomes will be assessed at baseline, 6 weeks, 3 months, and 6 months. Adverse events and patient-reported comfort will be documented at each follow-up visit.Timepoint: Baseline, 6 weeks, 3 months, and 6 months | — |
Countries
India
Contacts
Public ContactDr Nitesh Kumar Rathi
Saveetha Medical College and Hospital
Outcome results
None listed