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Evaluation of Safety and Efficacy of Minimally Invasive Surgery for Hallux Valgus: A Prospective, International Multicenter Clinical Study

Evaluation of Safety and Efficacy of Minimally Invasive Surgery for Hallux Valgus: A Prospective, International Multicenter Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110982
Enrollment
Unknown
Registered
2025-10-23
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

Interventions

Group A: Intramedullary Plate Group:None
Third-Generation Minimally Invasive Transverse Osteotomy Group:None
Group C: Open Surgery Group:None

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged 18 years of age or older, regardless of gender; 2.Clinical diagnostic criteria: Definite diagnosis of hallux valgus, manifested as hallux valgus deformity of the first metatarsophalangeal joint (Hallux Valgus Angle, HVA >= 15°) and first metatarsal adduction (Intermetatarsal Angle, IMA > 9°); accompanied by at least one of the following symptoms: persistent medial bunion pain (Visual Analog Scale, VAS>= 4 points); difficulty in wearing shoes or abnormal gait; 3.Imaging criteria: On weight-bearing X-rays, the angle between the first metatarsal and phalanx (HVA) >= 15°; the angle between the first and second metatarsals (IMA) > 9°; definite presence of other combined forefoot pathologies, such as metatarsalgia, claw toes, subluxation of the metatarsophalangeal joint, and degeneration of the metatarsophalangeal joint; 4.Failure of conservative treatment: Ineffectiveness after standardized conservative treatment for at least 6 months, including wearing custom orthotic insoles or hallux valgus braces; oral administration of non-steroidal anti-inflammatory drugs (NSAIDs); physical therapy (e.g., ultrasound, shockwave therapy); 5.Patients scheduled to undergo the surgical procedures under investigation; 6.Subjects voluntarily agree to participate in this study and sign the informed consent form in writing.

Exclusion criteria

Exclusion criteria: 1.Patients with poor compliance; 2.Patients with severe osteoporosis; 3.Patients with severe cardiovascular and cerebrovascular diseases; 4.Patients complicated with rheumatoid arthritis; 5.Patients complicated with severe metatarsophalangeal joint arthritis; 6.Patients who have undergone previous forefoot surgery and require revision surgery; 7.Patients with mental illness who are unable to cooperate; 8.Pregnant patients.

Design outcomes

Primary

MeasureTime frame
American Orthopaedic Foot and Ankle Society (AOFAS) Forefoot Score;

Secondary

MeasureTime frame
Visual Analog Scale (VAS) Pain Score;Hallux Valgus Angle;Intermetatarsal Angle;Patient Satisfaction;Plantar Pressure Analysis;Gait Symmetry;Postoperative Functional Recovery Time;

Countries

China

Contacts

Public ContactZhongmin Shi

Shanghai Sixth People's Hospital

18930177323@163.com+86 189 3017 7323

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026