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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06211504
Other study ID # 2023-02892-01
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 11, 2024
Est. completion date April 11, 2028

Study information

Verified date April 2024
Source Region Skane
Contact Ida Osbeck, MD
Phone +46 708 49 73 79
Email ida.osbeck@skane.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Description:

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Study Design


Intervention

Device:
ProStop, sinus tarsi implant (STI)
Insertion of a sinus tarsi implant (ProStop from Arthrex) in sinus tarsi
Procedure:
Conventional surgery
MDCO - medial displacement calcaneal osteotomy FDL transfer - flexor digitorum longus tendon transfer to the navicular bone Spring ligament repair - reconstruction of the spring ligament Strayer's procedure - gastrocnemius recession (if necessary) Cotton osteotomy - medial cuneiform opening wedge osteotomy (if necessary)

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (12)

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Outcome

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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