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New treatment option for Acquired Adult Flatfoot Deformity
Official title Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity
ClinicalTrials.gov ID: NCT06211504
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 75
You may be able to join if
- Patients with AAFD stage II, in whom the talonavicular uncoverage is not considered by the treating surgeon to require an additional lateral column...
- Age 16-75 years, either sex
- Failed non-surgical treatment including 3 months of physiotherapy
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hässleholm, Skåne County, Sweden
- Malmö, Skåne County, Sweden
- Gothenburg, Västra Götaland County, Sweden
- Eksjö, Sweden
- Falun, Sweden
- Mölndal, Sweden
- Östersund, Sweden
- Uppsala, Sweden
- Vaxjo, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hässleholm, Skåne County, Sweden; Malmö, Skåne County, Sweden; Gothenburg, Västra Götaland County, Sweden; Eksjö, Sweden; Falun, Sweden; Mölndal, Sweden and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.