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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 130
- 试验地点
- 19
- 主要终点
- Meary's angle
研究概览
简要总结
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.
详细描述
MDCO is a commonly used procedure with few complications. 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 difficult to achieve and medial soft tissue is still stressed leading to recurring deformity. The sinus tarsi implant (STI) has been described to function as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneal eversion, and lifting talar head. This is suggested to create a better correction of the deformity with enhanced appearance of the foot and potentially better long-term functional results.
Methods
Trial design and setting The study is a prospective multicenter randomized controlled trial conducted at nine orthopedic centers in Sweden. The participating centers are Hässleholm hospital, Skåne University Hospital in Malmö, Capio Ortho Center in Malmö and Göteborg, Sahlgrenska University hospital in Mölndal, Uppsala University Hospital, Falun Hospital, Östersund Hospital, Eksjö Hospital and Växsjö Hospital.
Screening
Patients referred to the orthopedic department at the participating centers will be evaluated by an orthopedic specialist with history and clinical examination. There will usually be radiographic imaging done before the visit. With clinical and radiographic examination, the surgeon can usually establish a diagnosis of AAFD and decide whether surgical treatment is indicated. Patients judged to fulfil the eligibility criteria are then given, by the surgeon, full verbal and written information about the aims and conduct of the trial as well as potential advantages and disadvantages of participation. Patients who accept participation will provide written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Meary's angle
时间窗: From baseline/preoperatively (max 6 months preoperatively) to 12 months postoperatively
Change in degrees of Meary's angle
次要结局
- Talar-2nd metatarsal angle(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Talar coverage angle(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- VAS change(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Talar uncoverage(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- EQ5D-3L change(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Meary's angle(From baseline/preoperatively (max 6 months preoperatively) to 4-5 and 24 months postoperatively)
- Calcaneal inclination angle(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Talar declination angle(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Angle between tibial and calcaneal midline(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Single heel-rise peak height(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Length of sick-leave(Asked at 4-5, 12 and 24 months postoperative)
- Medial cuneiform height(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- SEFAS change(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Degree of satisfaction regarding the appearance of foot(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Degree of satisfaction regarding the shoe-wear(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Adverse events(At 12 and 24 months postoperative)
- Single heel-rise endurance(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Degree of satisfaction regarding the results of the surgery(Measured at 4-5, 12, and 24 months postoperatively)
- Degree of satisfaction regarding the stability of the foot(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)
- Degree of satisfaction regarding the strength of the foot(From baseline/preoperatively (max 6 months preoperatively) to 4-5, 12, and 24 months postoperatively)