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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Page 1 of 3 (10 locations)

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

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity | DecenTrialz