Unicondylar - or Total Knee Replacement in Medial Gonarthritis? A Randomized Study of Patient Related Outcome Measures, Function and Muscle Mass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Muscle mass
研究概览
简要总结
Patients with medial gonarthritis are randomised to a unicompartmental or a total knee replacement.
Primary outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT Secondary aims: functional tests, gait analysis, health related quality of life and patient related outcome.
详细描述
Objective: The investigators aim with the present study was to compare patient related outcome measurements, knee function and muscle mass in patients operated with an UKR or a TKR for medial gonarthritis.
Hypothesis: The investigators hypothesize that a greater number of patients might benefit from a less invasive surgery in terms of increased quality of life, function and muscle mass.
Primary Outcome: Thigh muscle cross sectional area and radiological attenuation measured by CT.
Secondary outcomes: Functional tests (timed up and go, 30s sit and stand, forward reach, forward step down, 6 min walk and 40 m walk test), knee strength (Biodex isokinetic dynamometer) and patient reported pain on a visual analogue scale (VAS). A number of PROMs: Health related quality of life (EQ-5D), Knee injury and Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS) and Forgotten Joint Score (FJS) as well as 3D movement and gait analysis.
Inclusion criteria: Unilateral medial osteoarthritis of the knee (Kellgren 3b-4), aged 50 or above.
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
- None
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medial gonarthritis, (Kellgren 3b-4)
- •correctible varus deformity less than 10 degrees
- •intact ACL
- •proficient in written and spoken swedish
排除标准
- •Valgus gonarthritis
- •flexion deformity of 10 degrees
- •knee flexion of less than 100 degrees
- •previous high tibial osteotomy
- •neuromuscular disorders of lower extremities
- •symptomatic osteoarthritis of the contralateral knee or any hip.
结局指标
主要结局
Muscle mass
时间窗: 2 years
Thigh muscle cross sectional area and radiological attenuation measured by CT
次要结局
- Health related outcome measurement, questionnaire(2 years)
- Muscle function(2 years)
- Patient reported outcome measurement, knee function questionnaire (PROM).(2 years)
研究者
Margareta Hedström
MD PhD
Karolinska Institutet