Flexible Flatfoot Clinical Trial
Official title:
Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity: a Randomized Controlled Trial
Verified date | April 2024 |
Source | Region Skane |
Contact | Ida Osbeck, MD |
Phone | +46 708 49 73 79 |
ida.osbeck[@]skane.se | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 IIA). 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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | April 11, 2028 |
Est. primary completion date | April 11, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 75 Years |
Eligibility | Inclusion Criteria: - AAFD stage IIA, with talonavicular uncoverage not exceeding 40% - 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Orthopedics - Eksjö Hospital | Eksjö | |
Sweden | Department of Orthopedics - Falun Hospital | Falun | |
Sweden | Department of Orthopedics - Hässleholm Hospital | Hässleholm | Skåne |
Sweden | Capio Ortho Center | Malmö | Skåne |
Sweden | Department of Orthopedics - Skåne University Hospital Malmö | Malmö | Skåne |
Sweden | Department of Orthopedics - Sahlgrenska University Hospital | Mölndal | |
Sweden | Department of Orthopedics - Östersund Hospital | Östersund | |
Sweden | Department of Orthopedics - Uppsala University Hospital | Uppsala | |
Sweden | Department of Orthopedics - Växjö | Växjö |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Meary's angle | Change in degrees of Meary's angle | From baseline/preoperatively (max 6 months preoperatively) to 12 months postoperatively | |
Secondary | Meary's angle | Change in degrees of Meary's angle | From baseline/preoperatively (max 6 months preoperatively) to 4-5 and 24 months postoperatively | |
Secondary | Calcaneal inclination angle | Change in degrees of Calcaneal inclination angle | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Talar declination angle | Change in degrees of talar declination angle | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Talar-2nd metatarsal angle | Change in degrees of talar-2nd metatarsal angle | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Talar coverage angle | Change in degrees of talar coverage angle | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Talar uncoverage | Change in percentage of talar uncoverage | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Medial cuneiform height | Change in height of the medial cuneiform bone to the floor | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Angle between tibial and calcaneal midline | Change in degrees of the angle between tibial and calcaneal midline on Salzman view | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | SEFAS change | Change in Self-Reported Foot and Ankle Score (0-48), where 0 represents worst function and pain in the foot and 48 represent normal function without pain | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | EQ5D-3L change | Change in the 3-level version of EuroQol-5-Dimension index (0-1), where 0 represents worst possible general health status of the patient and 1 represents best possible health status | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | VAS change | Change in visual analog scale where 0 represents no pain and 10 represents worst possible pain | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Degree of satisfaction regarding the results of the surgery | A question "How satisfied are you with the results of the surgery?" will be answered with one of five options: 1. "Very satisfied", 2. "Satisfied", 3. "Quite satisfied", 4. Neither satisfied nor unsatisfied", 5. "Dissatisfied" | Measured at 4-5, 12, and 24 months postoperatively | |
Secondary | Degree of satisfaction regarding the appearance of foot | A question "How satisfied are you with the appearance of your foot?" will be answered with one of five options: 1. "Very satisfied", 2. "Satisfied", 3. "Quite satisfied", 4. Neither satisfied nor unsatisfied", 5. "Dissatisfied" | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Degree of satisfaction regarding the shoe-wear | A question "How satisfied are you with the shoes you are able to wear?" will be answered with one of five options: 1. "Very satisfied", 2. "Satisfied", 3. "Quite satisfied", 4. Neither satisfied nor unsatisfied", 5. "Dissatisfied" | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Degree of satisfaction regarding the strength of the foot | A question "How satisfied are you with the strength of your foot?" will be answered with one of five options: 1. "Very satisfied", 2. "Satisfied", 3. "Quite satisfied", 4. Neither satisfied nor unsatisfied", 5. "Dissatisfied" | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Degree of satisfaction regarding the stability of the foot | A question "How satisfied are you with the stability of your foot?" will be answered with one of five options: 1. "Very satisfied", 2. "Satisfied", 3. "Quite satisfied", 4. Neither satisfied nor unsatisfied", 5. "Dissatisfied" | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Adverse events | Number of adverse events | At 12 and 24 months postoperative | |
Secondary | Single heel-rise peak height | Change in single heel-rise peak height (cm from lowest part of heel to floor) | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Single heel-rise endurance | Change in single heel-rise endurance (total positive work) | From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively | |
Secondary | Length of sick-leave | Duration of postoperative sick-leave | Asked at 4-5, 12 and 24 months postoperative |
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