Condition: Acquired Adult Flatfoot Deformity · Flat Foot · Flexible Flatfoot · Sponsor: Region Skane
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 (STI) could work as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneus eversion, and lifting talar head. This additional procedure will create a better correction of the deformity with enhanced appearance of the foot and better long-term functional results. Methods: This is a multi-center randomized controlled trial designed to assess the efficacy of STI as an adjuvant procedure to MDCO in patients with mobile AAFD (Stage II). Patients aged 16 to 75 years, referred to one of the orthopedic centers involved in …
This description comes directly from the study's public registry record.
Ida Osbeck, MD · +46 708 49 73 79 · ida.osbeck@skane.se
Isam Atroshi, MD, PhD · +46 44 309 12 60 · isam.atroshi@skane.se
Always discuss trial participation with your own doctor first.
| Department of Orthopedics - Hässleholm Hospital | Hässleholm, Skåne County, Sweden | Recruiting |
| Department of Orthopedics - Skåne University Hospital Malmö | Malmö, Skåne County, Sweden | Not Yet Recruiting |
| Capio Ortho Center | Malmö, Skåne County, Sweden | Recruiting |
| Capio Ortho Center Göteborg | Gothenburg, Västra Götaland County, Sweden | Recruiting |
| Department of Orthopedics - Eksjö Hospital | Eksjö, Sweden | Not Yet Recruiting |
| Department of Orthopedics - Falun Hospital | Falun, Sweden | Not Yet Recruiting |
| Department of Orthopedics - Sahlgrenska University Hospital | Mölndal, Sweden | Not Yet Recruiting |
| Department of Orthopedics - Östersund Hospital | Östersund, Sweden | Recruiting |
| Department of Orthopedics - Uppsala University Hospital | Uppsala, Sweden | Recruiting |
| Department of Orthopedics - Växjö | Vaxjo, Sweden | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06211504