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Subtalar arthroereisis versus subtalar arthroereisis combined with Kinder for flexible flat foot with painful type II accessory navicular in children: a randomized, controlled, non-inferior study

Subtalar arthroereisis versus subtalar arthroereisis combined with Kinder for flexible flat foot with painful type II accessory navicular in children: a randomized, controlled, non-inferior study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045339
Enrollment
Unknown
Registered
2021-04-03
Start date
2021-08-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

flexible flat foot

Interventions

Single surgery group:Subtalar arthroereisis
Combined surgery group:Subtalar arthroereisis combined Kinder

Sponsors

Sun Yat-Sen Menmorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.Aged 8-14 years, male or female; 2.Clinically diagnosed as flexible flat foot with walking pain or abnormal walking posture; 3.Clinically diagnosed as type II accessory navicular with pain symptoms at the accessory navicular, MRI showed edema at the accessory navicular-navicular joint; 4.The conservative treatment was ineffective for 3 months, and operative evidence was obtained after evaluation; 5.Informed consent for clinical study signed by the guardian; 6.The patient is in good general condition and can tolerate anesthesia and surgery; 7.Willing and able to comply with the plan, rehabilitation, nursing and follow-up protocols of the study.

Exclusion criteria

Exclusion criteria: 1.Rigid flat foot; 2.Congenital neuromuscular disease; 3.Previous surgery on the affected side of the foot and ankle; 4.Systemic polyligamentous laxity; 5.The patient has an autoimmune disease and the disease is active; 6.Mental abnormality or any mental abnormality that affects the patient's behavior; 7.Patients with any severe organ dysfunction, abnormal blood coagulation, etc., who cannot tolerate surgery.

Design outcomes

Primary

MeasureTime frame
AOFAS Ankle-Hindfoot Scale;

Secondary

MeasureTime frame
Visual analogue scale;Pitch angle;Lateral talar-first metatarsal angle;Anteroposterically, the first metatarsal Angle of the talus;Talonavicular coverage angle;Calcaneal valgus Angle;

Countries

China

Contacts

Public ContactZeng Gang

Sun Yat-Sen Menmorial Hospital, Sun Yat-Sen University

zengg5@mail.sysu.edu.cn+86 15820291284

Outcome results

None listed

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