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

Launched by REGION SKANE · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treating a foot condition called adult acquired flatfoot deformity (AAFD), which can cause pain and difficulty walking. The researchers want to see if adding a small device called a sinus tarsi implant (STI) during surgery can improve outcomes for patients undergoing a common procedure known as medial displacement calcaneal osteotomy (MDCO). The trial will involve around 130 patients between the ages of 16 and 75 who have already tried physical therapy without success. Participants will be randomly assigned to receive either the MDCO surgery with or without the STI.

If you join this trial, you will have regular check-ups and complete surveys to track your recovery and any changes in your foot’s condition over two years. The goal is to find out if using the STI helps to reduce pain and improve the overall function and appearance of the foot compared to the standard procedure alone. This is an important study because it could lead to better treatment options for those suffering from this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • AAFD stage IIA, with talonavicular uncoverage not exceeding 40%
• • Age 16-75 years, either sex
• • Failed non-surgical treatment including 3 months of physiotherapy
• Exclusion Criteria:
• • 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