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临床试验/NCT05685706
NCT05685706招募中不适用

Knee-Hip-Spine Harmony: The Relationship Between Sagittal Spinal Alignment in Total Hip/Knee Arthroplasty

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
The Forgotten Joint Score-12 (FJS-12)

研究概览

简要总结

Concomitant osteoarthritis of hip/knee joint and lumbar spinal degeneration is commonly seen in elderly population. These degeneration changes of spine would change sagittal or coronal alignment and spinal flexibility in varies degrees. Total hip and knee arthroplasty (THA/TKA) are among the most successful orthopedic operations performed, aiming at the alleviation of osteoarthritic pain. Normal alignment of the spine and pelvis in the sagittal plane is critical to maintain an upright standing position with minimal energy consumption. However, there is a scarcity of studies on how THA or TKA influences the parameters of the spine and the pelvis.

Compared with the balance of coronal plane, more attention is paid to the balance of sagittal plane. The objectives of this study are to investigate changes in the truncal parameters after THA or TKA and assess whether these parameters are improved or deteriorated after these operations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary degenerative arthritis of the knee or hip
  • Those who have undergone artificial knee or hip replacement surgery
  • Follow up surgery for at least 1 year
  • Track the whole trunk lower limb sagittal plane coronal aligament before and after surgery

排除标准

  • Previous hip surgery
  • Previous spine surgery
  • Contracture after hip fusion surgery
  • Scoliosis over 10 degrees combined with neuropathy
  • Patients with flexion contracture after knee joint surgery
  • Rheumatoid arthritis lesions

结局指标

主要结局

The Forgotten Joint Score-12 (FJS-12)

时间窗: Post-operative at 24th month

The Forgotten Joint Score-12 (FJS-12) is a validated patient-reported outcome measure (PROM) tool designed to assess artificial prosthesis awareness during daily activities following total hip arthroplasty (THA). The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities (Rosinsky et al., 2019).

EQ-5D

时间窗: Post-operative at 24th month

EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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