Tissue Sparing Surgery in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- evaluate spatiotemporal variables in meters among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
研究概览
简要总结
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior posterolateral approach (sperimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata might elicit a better outcome in terms of gait, balance, strengths recovery, clinical performance, patient reported outcome measurement (Short Form-12(SF-12); Hip disability and Osteoarthritis Outcome Score (HOOS)) and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.
The investigators expect an improvement on selected gait analysis parameters in sperimental approach in order of 2% of range of motion (ROM) recorded 1 month after surgery. Based on this assumption sample size calculation will be conducted.
详细描述
Rationale of the study is to evaluate through a prospective randomized controlled study if a modified direct superior approach (experimental approach) to the hip articulation which entirely spares i.e. avoids the sacrifice of the fascia lata (posterolateral approach) might elicit a better outcome in terms of gait, balance,strenghts recovery, clinical performance, patient reported outcome measurements and overall recovery time in patients undergoing TotalHipArthroplasty with the aid of dedicated, modified instrumentation in order to properly access this modified route.Two patients groups will randomly be allocated in one of the two group with a computer generated 1:1 randomization table.Total number of subjects participating in the study:50.
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
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients affected by:
- •Non-inflammatory degenerative joint disease, including osteoarthritis
- •Patients in the age from 60 to 85 included
- •Consenting to actively participate in the study and in the rehabilitation follow up program as foreseen by the study
- •18 ≤ Body Mass Index (BMI) ≥ 30 kg/m2
- •patient without contralateral THA
排除标准
- •Revision procedures where other treatments or devices have failed
- •Active infection or suspected latent infection in or about the hip joint
- •Bone stock that is inadequate for support or fixation of the prosthesis
- •skeletal immaturity
- •any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complication in post-operative care
- •Obesity (BMI ≥30kg/m2)
结局指标
主要结局
evaluate spatiotemporal variables in meters among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
时间窗: Change from Baseline spatiotemporal variables in meters at 3 months
spatiotemporal variables: step length (meters), stride length (meters).
evaluate spatiotemporal variables in percentage among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
时间窗: Change from Baseline spatiotemporal variables in percentage at 3 months
Spatiotemporal variables: stance phase (percentage), swing phase (percentage)
evaluate kinematic parameters in degrees among two different access routes, one a traditional posterolateral mini approach and the other a modified posterolateral superior approach fascia lata sparing
时间窗: Change from Baseline Kinematic parameters in degrees at 3 months
Kinematic parameters (in degrees): hip flexion-extension ROM, hip abduction-adduction ROM, Hip rotation ROM, Hip Obliquity ROM.
次要结局
- evaluation of instability with BEStest(Change from Baseline BESTest at 3 months)