Proximal Medial Gastriocnemius Recession for Chronic Plantar Fasciitis - a Prospective Kohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Manchester Oxford Foot Questionnaire (MOxFQ)
研究概览
简要总结
This prospective kohort study will follow 150 patients treated with proximal medial gastrocnemius recession for plantar fasciitts. Follow up time is two years and the main outcome is the Manchester Oxford Foot Questionnaire.
A regression analasys will be performed to identify possible patient baseline factors that may affect the effect of surgery,
详细描述
Recent studies indicate that chronic plantar fasciitis can be treated effectively with Proximal Medial Gastrocnemius Recession (PMGR). In our hospital this treatment has been inocorporated into routine care. This prospective kohort study will follow 150 patients with chronic planatar fasciitis operated with PMGR study. The follow up time is 2 years and the study aims at documenting the effect of the surgery with PROMS (patient related outcome measures), MRI (magnetic resonnance imaging) and ankle movement measurements. 26 patient-related baseline factors will also be registered. A regression analysis will be performed to identify factors that may be predictive to the effect of PMGR surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Diagnosis plantar fasciitis verified clinically by orthopaedic surgeon.
- •Diagnosis verified by MRI. MRI criteria: Thickening of the plantar fascia, oedema in the calcaneus, pathological singal changes in the plantar fascia (37)
- •Duration of symptoms must be at least 12 months.
- •An isolated gastrocnemius contracture must be verified with the Silverskiölds test before inclusion.
- •Conventional Physical Therapy must have been tried at least three months without positive effects on symptoms from affected foot.
排除标准
- •Previously undergone surgery for plantar fasciitis.
- •Patients with severe talocrural pathology or serious malalignment of foot and ankle
- •Severely reduced peripheral circulation or chronic ulcerations of the foot
- •History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- •Patients with a contraindication/non-compliance for MRI examination.
- •Unable to walk without aid.
- •Not able to read and/or speak a Scandinavian language or English adequately.
结局指标
主要结局
Manchester Oxford Foot Questionnaire (MOxFQ)
时间窗: 2 years postoperatively
Patient Related Outcome Measure (PROM) validated for disorders in foot and ankle
次要结局
- MRI (magnetic resonancd imaging) findings(Baseline, 2years)
- Adverse events(Baseline, 6 weeks, 12 weeks, 1 year, 2 years)
- Ankle movement(Baseline, 12 weeks, 2 years)
- Assessment of treatment success(at 2 years)
- Gait analysis (Length of stride. Centimeters)(Baseline, 3 months)
- Assessment of treatment success - other treatments(at 2 years)
- EQ5D (EuroQol questionnaire )(Baseline, 12 weeks, 1 year, 2 years)
- Gait analysis Knee extension while maximal dorsiflexion of ankle during stance (degrees)(Baseline, 3 months)
- Assessment of treatment success -pain(at 2 years)
- Assessment of treatment success - patient acceptable symptom state(at 2 years)
- VAS (visual analogue scale)(Baseline, 12 weeks, 1 year, 2 years)
- Gait analysis Maximal external rotation of ankle during stance (degrees)(Baseline, 3 months)
- Assessment of treatment success - physical activity(at 2 years)
- Gait analysis Ankle power(Baseline, 3 months)
- Gait analysis Cadence (steps/minute)(Baseline, 3 months)
- Assessment of treatment success - daily living(at 2 years)
- Gait analysis - Maximal ankle dorsiflexion during stance (degrees)(Baseline, 3 months)