The Value of Autologous Tenocyte Implantation in Patients With Chronic Achilles Tendinopathy: a Double-blind Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- VISA-A score
研究概览
简要总结
This study is designed to compare the treatment of 2 groups in patients with Achilles tendinopathy: autologous tenocytes injection in combination with exercises versus saline injection in combination with exercises
详细描述
Overuse injury of the Achilles tendon is a common entity. When the exact origin of tendon pain is unclear, the term tendinopathy is preferred. Most accepted treatment at this moment is an eccentric exercise programme, according to the Dutch guidelines. However, a recent systematic review on the effectiveness of eccentric exercises to treat lower extremity tendinoses concluded that it is unclear whether eccentric exercises are more effective than other forms of treatment. Recent studies described new treatment strategies in tendinopathies, such as the use autologous Tenocyte Implantation (ATI). This treatment option can participate actively in tissue repair processes on cell level. The only published clinical pilot study in tendon research reported 60% improvement in all scores after 6 months follow-up.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain on palpation 2-7 cm proximal from the tendon insertion ("midportion")
- •Symptoms > 2 months
- •Age 18-55 years
排除标准
- •Clinical suspicion of insertional disorders , Achilles tendon rupture, plantar flexor tenosynovitis, sural nerve pathology, peroneal subluxation
- •Condition of the Achilles tendon caused by medications such as quinolones and statins
- •Known to have the following disorders: spondylarthropathy, gout, hyperlipidemia, rheumatoid arthritis and sarcoidosis.
- •Antibiotics allergy (aminoglycoside group)
- •A condition that prevents the patients from executing an active rehabilitation programme
- •Patient has received an injection for this injury
- •Patient has received surgical intervention for this injury
- •Patient has already one site (left or right) included in this study
- •Patient does not wish, for whatever reason, to undergo one of the two treatments
- •Known pregnancy
- •Nursing women
研究组 & 干预措施
Autologous Tenocyte Implantation
Intratendinous ATI (autologous tenocyte implantation) injection with eccentric exercises
干预措施: Autologous Tenocyte Implantation (Other)
Saline injection
Intratendinous saline injection with eccentric exercises
干预措施: Saline (Other)
结局指标
主要结局
VISA-A score
时间窗: 24 weeks
a validated instrument to detect the severity of symptoms in patients with Achilles tendinopathy
次要结局
- Ultrasonographic tendon repair - Ultrasonographic Tissue Characterization (UTC)(24 weeks)
- Subjective patient satisfaction(24 weeks)
- Returning to sports level(24 weeks)
研究者
Prof J.A.N. Verhaar
Prof. J.A.N. Verhaar
Erasmus Medical Center