Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in quality of life one year after foot surgery including a peroneus longus transfer
研究概览
简要总结
At the foot and ankle group at the Department of Orthopaedics, Uppsala University Hospital, the routine is to perform a tendon transfer of peroneus longus to brevis in case of a ruptured peroneus brevis tendon in the ankle. The reports of patient outcome from this surgery varies in different studies. The aim of the current study is to analyse how well the patients think their general health has improved after the surgery, and how they perceive that the foot function has changed after the surgery. In an objective way the changes in gait after surgery will be measured with gait analysis.
详细描述
The patients are asked to fill in Short Form 36 (SF 36) and Foot and Ankle Outcome Score (FAOS) before surgery, six months and one year after surgery. At each visit a clinical examination is done by a foot and ankle surgeon, according to a protocol. At the same visit a gait analysis is performed with force plates, registration of speed and gait length and 3D recording. The surgery itself is performed according to the clinic's usual protocol and standardised, so all patients are treated in the same way. The physiotherapy is also done according to a protocol. The surgeon is not involved in the follow- up, this is done by another surgeon, and the gait analysis is done by a physiotherapist.
The patients are chosen from two groups: primary tear of the peroneus brevis tendon, requiring a longus to brevis transfer, and primary tear of the peroneus longus tendon, requiring removal of the tendon.
The first group has a sub-group: patients who are in need of a calcaneal osteotomy because of a severe varus hindfoot. The reason the study group is so heterogenous is that peroneus longus and brevis tears are very rare, and 10 patients are referred to the Orthoaedic deparment each year, that need this type of surgery. The sample size has been calculated to 30 patients (based on changes in force measurements during gate), but more patients need to be involved in the study in order to have 30 patients at one year follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
- •Eligible for surgery of peroneal tendon tears
排除标准
- •Other injuries in the affected foot that might affect the gait.
- •Previous surgery in the affected foot that might affect the gait.
- •Neurological conditions in the lower extremities that might affect the gait.
- •Patient can not understand the questionnaires or can not understand Swedish
结局指标
主要结局
Changes in quality of life one year after foot surgery including a peroneus longus transfer
时间窗: Before surgery to 12 months after surgery
Patients quality of life is measured with the self-administered Short Form 36 ( SF 36 ) (range 0-100 points, 100 points best health) before surgery, at 6 months and 12 months after surgery.
Changes in foot function one year after surgery including a peroneus longus transfer
时间窗: Before surgery to 12 months after surgery
Changes in foot function after surgery is measured using a patient reported outcome measure: Foot and Ankle Outcome Score (FAOS) (range 0-100 points, 100 points being a totally healthy foot). The patient fill in the score before surgery, at 6 months and 12 months after surgery.
次要结局
- Weakness in push-off during gait(One year after surgery)
研究者
Anna Sprinchorn
Principal Investigator
Uppsala University