NCT06211504 Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity
| NCT ID | NCT06211504 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Region Skane |
| Condition | Acquired Adult Flatfoot Deformity |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2024-07-31 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 study, will be invited to participate if they fulfil the trials eligibility criteria. In total, 130 patients who provide informed consent will be randomized to either MDCO with STI or MDCO without STI (65 patients in each group). The included patients will be clinically and radiographically examined. They will also fill out a form before surgery and 4-5 months, 1 year and 2 years postoperatively. The form will include Self-Reported Foot and Ankle Score (SEFAS) and Euro-QoL 5 Dimensions (EQ-5D). The trials primary outcome will be change in Meary's angle. Secondary outcomes include additional radiographic changes, change in SEFAS score, EQ-5D index, pain according to visual analog scale (VAS), satisfaction assessment, clinical outcome measures, the length of postoperative sick-leave and rate of complications. Discussion: This is the first randomized controlled trial assessing the efficacy of a sinus tarsi implant as an adjuvant procedure to MDCO.
Eligibility Criteria
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
Contact & Investigator
Ida Osbeck, MD
PRINCIPAL INVESTIGATOR
Region Skane
Frequently Asked Questions
Who can join the NCT06211504 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 75 Years, studying Acquired Adult Flatfoot Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06211504 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06211504 currently recruiting?
Yes, NCT06211504 is actively recruiting participants. Contact the research team at ida.osbeck@skane.se for enrollment information.
Where is the NCT06211504 trial being conducted?
This trial is being conducted at Hässleholm, Sweden, Malmö, Sweden, Malmö, Sweden, Gothenburg, Sweden and 6 additional locations.
Who is sponsoring the NCT06211504 clinical trial?
NCT06211504 is sponsored by Region Skane. The principal investigator is Ida Osbeck, MD at Region Skane. The trial plans to enroll 130 participants.