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

RecruitingPhase 4Ages 16 Years - 75 YearsAllRegion Skane
NCT06211504 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 treatment of AAFD. One of the most common treatments for mobile AAFD is medial displacement calcaneal osteotomy (MDCO) with or without adjuvant soft tissue procedures. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three planes with hypereversion of the calcaneus, anterior translation of the talus over the calcaneus and tilting/drop of the calcaneal head. Because of these multiple forces, the healing of MDCO in the intended position can sometimes be hard to achieve and medial soft tissue is still stressed leading to recurring deformity. The investigators believe that adjuvant insertion of a sinus tarsi implant (ST

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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
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What it tests

  • ProStop, sinus tarsi implant (STI)
  • Conventional surgery
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Where

10 sites
Department of Orthopedics - Hässleholm Hospital
Hässleholm, Sweden
Department of Orthopedics - Skåne University Hospital Malmö
Malmö, Sweden
Capio Ortho Center
Malmö, Sweden
Capio Ortho Center Göteborg
Gothenburg, Sweden
Department of Orthopedics - Eksjö Hospital
Eksjö, Sweden
Department of Orthopedics - Falun Hospital
Falun, Sweden
Department of Orthopedics - Sahlgrenska University Hospital
Mölndal, Sweden
Department of Orthopedics - Östersund Hospital
Östersund, Sweden

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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