Prospective Evaluation of Non-Surgical and Arthroscopic Treatment for Hip Microinstability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
研究概览
简要总结
Microinstability of the hip joint is an important cause of hip pain and reduced hip function in young and active individuals. Hip microinstability is due to extraphysiologic hip motion and could be secondary to acetabular dysplasia, connective tissue disorder, macrotrauma, microtrauma, iatrogenic- and idiopathic causes. Treatment for hip microinstability is initiated with non-surgical treatment consisting of physiotherapy aimed mainly at stability. If non-surgical treatment fails, surgery with arthroscopic plication of the hip joint capsule is the preferred method. This study evaluates non-surgical and arthroscopic treatment for hip microinstability regarding hip function and adverse events.
详细描述
This is a prospective cohort study evaluating 26 participants above 18 years of age undergoing non-surgical and surgical treatment for microinstability of the hip joint. Participants with findings on physical examination and imaging suggestive of hip microinstability will undergo six months of physiotherapy aimed at stabilizing the hip joint. If non-surgical treatment fails, a diagnostic hip arthroscopy will be performed, and if hip microinstability is confirmed, the participants will undergo a plication of the hip joint capsule. Participants will be evaluated with Patient-Reported Outcome Scores (PROMs) and strength- and function tests at time of enrollment and at 6-, 12- and 24 months following treatment. The primary outcome is hip function determined by PROMs and strength- and function tests. Secondary outcomes include Health-Related Quality of Life (HRQL), sport activity level and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hip microinstability
- •Minimum 18 years old
排除标准
- •Hip osteoarthritis
- •Severe hip dysplasia
- •Perthes disease or avascular necrosis of the femoral head
- •Previous surgery to the hip joint
结局指标
主要结局
Mean Change from Baseline in Hip Function on the International Hip Outcome Tool (iHOT-12) at 24 Months
时间窗: 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Mean Change from Baseline in Hip Function on the Copenhagen Hip and Groin Outcome Score (HAGOS) at 24 Months
时间窗: 24 Months
Participant-reported hip function. Minimum score 0, maximum score 100 (higher score mean a better outcome).
Mean Change from Baseline in Hop Performance at 24 Months
时间窗: 24 Months
Hop performance will be measured with 3 single-leg hops: vertical hop (Muscle lab, Ergotest Technology, Oslo, Norway), hop for distance and a 30-second side-hop test. Each hop test is performed with the patients holding their hands behind their back. For the vertical hop, the time from take-off to landing is converted into hop height in centimeters. In the hop for distance test, the distance between top of the toes at take-off to heel at landing is measured in centimeters. For the 30 second side hop test, one trial per leg is allowed, where the patient is instructed to hop as many times as possible over 2 lines 40 centimeters apart. The number of hops is recorded. Higher height, longer distance and higher number of hops means a better outcome.
Mean Change from Baseline in Maximal Isometric Hip Muscle Force in Newton at 24 Months
时间窗: 24 Months
Maximal hip isometric muscle force will be assessed using a dynamometer (Hoggan MicroFET2, Hoggan, Scientific L.L.C., Salt Lake City, USA) for hip flexion, adduction, abduction, and extension. The maximal developed force in Newton will be recorded. Higher Newton value means a better outcome.
次要结局
- Mean Change from Baseline in Hip Function on the EuroQoL-5 Dimensions (EQ-5D) at 24 Months(24 Months)
- Mean Change from Baseline in Hip Function on the Hip Sport Activity Scale (HSAS) at 24 Months(24 Months)
- Type and Number of Adverse Events at 24 Months(24 Months)
- Single Question "Satisfied with Treatment?" at 24 Months(24 Months)