Status:
RECRUITING
Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity
Lead Sponsor:
Region Skane
Conditions:
Acquired Adult Flatfoot Deformity
Flat Foot
Eligibility:
All Genders
16-75 years
Phase:
PHASE4
Brief Summary
Background: Adult acquired flatfoot deformity (AAFD) is a deformity of the foot which leads to pain and an altered gait pattern. There are several different surgical interventions available for treatm...
Detailed Description
MDCO is a commonly used procedure with few complications. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three plan...
Eligibility Criteria
Inclusion
- Patients with AAFD stage II, in whom the talonavicular uncoverage is not considered by the treating surgeon to require an additional lateral column lengthening
- Age 16-75 years, either sex
- Failed non-surgical treatment including 3 months of physiotherapy
Exclusion
- Previous ipsilateral surgery for AAFD
- General hypermobility (Beighton score \> 6)
- Osteoarthritis in the hindfoot joints, ankle joint or first tarsometatarsal joint
- Rheumatoid arthritis
- Inability to answer patient-reported outcome measures (PROMs) due to language difficulties or cognitive disorder
- Current smoker
- Current pregnancy
- Severe medical illness
- Known abuse of drugs and/or alcohol
- Previous ipsilateral hindfoot fracture including Lisfranc injury
Key Trial Info
Start Date :
July 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06211504
Start Date
July 31 2024
End Date
December 31 2029
Last Update
December 2 2025
Active Locations (10)
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1
Department of Orthopedics - Hässleholm Hospital
Hässleholm, Skåne County, Sweden, 281 38
2
Department of Orthopedics - Skåne University Hospital Malmö
Malmo, Skåne County, Sweden, 214 28
3
Capio Ortho Center
Malmo, Skåne County, Sweden, 215 32
4
Capio Ortho Center Göteborg
Gothenburg, Västra Götaland County, Sweden