DRKS00028028已完成未知
se of a smartphone application (Orthopy App) to improve preoperative and postoperative therapy in patients with ACL rupture compared to conventional standard of care treatment - a randomized, monocentric study.
Orthopy Health GmbH0 个研究点目标入组 80 人开始时间: 2022年2月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Confirmed diagnosis - M23.61 (Internal injury of knee joint anterior cruciate ligament) orS83.53 (Rupture of the anterior cruciate ligament)
- •- From the age of 18
- •- Planned surgical reconstruction (Arthroscopic,autologous tendoplasty)
- •- Participants are capable of giving consent, have full legal capacity and understand the nature, extent, significance and consequences of examination and treatment
- •- Informed consent to participate
- •- Rupture of the anterior cruciate ligament and planned surgery less than than 6 months apart
- •- Possession of and sufficient skills in the use of a Smartphone (iOS or Android operating system)
- •- Willingness and existing technical to use the Orthopy app
- •- Sufficient knowledge of German language
排除标准
- •- Bucket handle lesion of a meniscus
- •- Cartilage damage > ICRS II°
- •- Complete second ligament injury with indication for intervention
- •- Multi-ligament injuries
- •- Knee joint dislocation
- •- Neurological damage/basic diseases
- •- Pre-surgery of the lower extremities
- •- Pregnancy
- •- Underlying rheumatic disease
- •- Non-compliance
- •- Chronic pain patients
- •- CE-determined app use exclusions:
- •Rheumatic, neuromuscular, or general systemic disease; obesity (BMI = 30); neoplastic disease; metabolic disease; inflammatory and systemic disease; autoimmune disease; immunocompromised patients.
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