DRKS00032793招募中Unknown
se of a smartphone application (Orthopy App) to improve pre- andpostoperative therapy in patients after anterior cruciate ligament rupture(with or without meniscal damage) or meniscal damage alone comparedto conventional standard of care treatment - a randomized, controlled,multicenter study - Orthopy for knee injuries main study
Orthopy Health GmbH0 个研究点目标入组 400 人开始时间: 2023年10月2日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 400
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
- •Patients are eligible for study inclusion if the following criteria are met:
- •- Any of the following confirmed diagnoses:
- •o S83.53 Tear of the anterior cruciate ligament
- •o M23.61 Internal injury of knee joint anterior
- •cruciate ligament
- •o S83.2 Meniscus tear, acute
- •o M23.2- Meniscus damage due to old tear or old injury
- •o M23.3- Other meniscal damage
- •- From 18 years of age
- •- More than 2 weeks between inclusion and surgery
- •- Planned surgical treatment with autologous tendoplasty for
- •cruciate ligament ruptures or planned surgical treatment after
- •meniscus damage
- •- In case of rupture of the anterior cruciate ligament - injury and
- •surgery are less than 6 months apart
- •- Possession and sufficient skills in the use of a smartphone
- •(iOS or Android operating system).
- •- Willingness as well as existing technical requirements (email
- •and internet access) to use the Orthopy App
- •- Willingness to train with the app on a regular basis and
- •participate in the study surveys
- •- Sufficient knowledge of German
- •- Participants are capable of giving consent, have full legal capacity,
- •and understand the nature, scope, significance, and
- •consequences of the examination and treatment
- •- Informed consent to participate
排除标准
- •Patients will be excluded from the study if they meet any of the following
- •- Basket joint lesion, radial tear, root avulsion of a meniscus
- •- Cartilage damage with need for regenerative therapy
- •- Second ligament injury treated surgically
- •- Multi-ligament injuries
- •- Knee joint dislocation
- •- Re-rupture of the anterior cruciate ligament
- •- Pregnancy
- •- Expected non-compliance with regard to therapy
- •- Chronic pain patients
- •- Use of the Orthopy app or similar health apps at study
- •enrollment or in the past.
- •- Participation in another study
- •- CE determined exclusions:
- •o I26 Pulmonary embolism
- •o I50 Heart failure
- •o J18 Pneumonia
- •o I80.2 Thrombosis, phlebitis and thrombophlebitis of other
- •deep vessels of the lower extremities
- •o M22.0 Habitual dislocation of the patella
- •o M23.4 Free joint body in knee joint
- •o M24.07 Free joint body: ankle and foot (tarsus, metatarsus,
- •toes, ankle, other joints of the foot)
- •o M00 Purulent arthritis
- •o M01 Direct joint infections in infectious and parasitic diseases
- •classified elsewhere.
- •- Other diseases and conditions that, based on the
- •investigator's assessment, militate against study
- •participation
研究者
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