Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy; A Multicenter, Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
研究概览
简要总结
This is a prospective cohort study that will follow 60 patients treated with Proximal Medial Gastrocnemius Recession for Chronic Mid-Portion Achilles Tendinopathy for 5 years postoperatively.
详细描述
Mid Portion Achilles Tendinopathy is a condition that usually resolves by itself without any kind of intervention. If the condition becomes chronic, eccentric training guided by a physical therapist seems to be the best non-surgical intervention. Surgical treatment has shown varying results and no gold-standard exists.
Tightness in the gastrocnemius muscle seems to be a contributing factor for many conditions in the foot and ankle region.
Retrospective material suggest that Proximal Medial Gastrocnemius Recession (PMGR) can be an effective treatment for this condition. No prospective material exists.
This study aims at including 60 patients with Chronic Mid-Portion Achilles Tendinopathy (CMPAT) that is non-responsive to eccentric training. Patients will be PMGR-surgery and followed for 5 years with PROMS, muscle function test and MRI scans.
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 CMPAT verified clinically by orthopedic surgeon. Symptoms must include mid-portion pain in the Achilles, swelling and reduced tolerance for weightbearing.
- •Verified diagnosis with MRI findings representing pathologic processes of tendon degeneration and repair (13). MRI no older than 12 months.
- •Duration of symptoms must be at least 12 months.
- •Isolated gastrocnemius tightness must be verified with the Silfverskiölds test before inclusion. The Silfverskiöld test is considered positive if ankle dorsiflexion is restricted to 5 degrees or less with the knee extended, and there is an increase of ankle dorsiflexion of at least 10 degrees when flexing the knee.
- •At least three months of conventional physical therapy with eccentric training must have been tried without providing relief of symptoms.
排除标准
- •Previous history of complete Achilles tendon rupture.
- •Other combined pathologies in the Achilles tendon of calf (Sequela from trauma, infections, cancer etc.).
- •Insertional Achilles tendinopathy.
- •Previously undergone surgery in affected tendon.
- •Patients with severe talocrural pathology or serious malalignment of foot and ankle.
- •Severely reduced peripheral circulation.
- •History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent.
- •Patients with a contraindication/non-compliance for MRI examination.
- •History of allergic reaction/anaphylactic reaction to local anesthetics.
- •Not able to read and/or speak a Scandinavian language or English adequately.
- •Other serious comorbidity that makes surgery unadvisable.
研究组 & 干预措施
Proximal Medial Gastrocnemius Recession Surgery
Patients will be operated with Proximal Medial Gastrocnemius Recession Surgery (PMGR) ad modum Barouk.
干预措施: Proximal Medial Gastrocnemius Recession (Procedure)
结局指标
主要结局
VISA-A - Victorian Institute of Sport Assessment- Achilles Questionnaire
时间窗: 5 years
A PROM validated for patients with achilles tendon disorders
次要结局
- Assessment of treatment success - pain(2 years)
- Adverse events(Baseline, 3 months, 1 year, 2 years, 5 years)
- Assessment of treatment success - Patient Acceptable Symptom State(2 years)
- MRI findings pre inclusion versus after 2 years.(baseline, 2 years)
- Eq-5D(Baseline, 3 months, 1 year, 2 years, 5 years)
- Assessment of treatment success - other treatments(2 years)
- Achilles Function Test battery(Baseline, 3 months, 2 years)
- VAS(Baseline, 3 months, 1 year, 2 years, 5 years)
- Assessment of treatment success - daily living(2 years)
- Ankle Dorsiflexion pre and postoperatively(Baseline, 3 months, 2 years)
- Assessment of treatment success - physical activity(2 years)
- Assessment of treatment success - calf pain(2 years)