Using a sinus tarsi implant to improve surgery for flatfoot deformity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of a sinus tarsi implant (STI) as an adjuvant procedure to medial displacement calcaneal osteotomy (MDCO) for treating mobile adult acquired flatfoot deformity (AAFD). The study aims to address the limitations of MDCO, which only corrects the deformity in one plane, by using the STI to provide additional support and improve overall foot alignment. Conducted as a multicenter randomized controlled trial across nine orthopedic centers in Sweden, patients will be evaluated and treated based on specific eligibility criteria. The trial seeks to determine if the STI can enhance surgical outcomes and long-term functional results for patients suffering from AAFD.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Orthopedics - Hässleholm Hospital
  Hässleholm, Skåne County, Sweden Recruiting
• Capio Ortho Center
  Malmö, Skåne County, Sweden Recruiting
• Capio Ortho Center Göteborg
  Gothenburg, Västra Götaland County, Sweden Recruiting
• Department of Orthopedics - Östersund Hospital
  Östersund, Sweden Recruiting
• Department of Orthopedics - Uppsala University Hospital
  Uppsala, Sweden Recruiting
• Department of Orthopedics - Skåne University Hospital Malmö
  Malmö, Skåne County, Sweden Not yet recruiting

Study contacts

• Principal investigator: Ida Osbeck, MD — Region Skane
• Study coordinator: Ida Osbeck, MD
• Email: ida.osbeck@skane.se
• Phone: +46 708 49 73 79

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.