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临床试验/CTRI/2024/04/064957
CTRI/2024/04/064957尚未招募Unknown

Comparison of clinical and radiological outcomes following total knee arthroplasty using medial pivot versus regular cruciate retaining prostheses

Medicover Hospital, hitech City, Hyderabad1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
Knee society score more than 80

研究概览

简要总结

Osteoarthritis is a common degenerative joint disorder affecting the elderly population.The knee is the principal peripheral joint affected, resulting in progressive loss of function, pain and stiffness. Total knee arthroplasty (TKA) is a common and successful treatment for end-stage osteoarthritis. The main goals of TKA are aimed at relieving pain, improving the patient’s quality of life, and restoring function while optimizing implant longevity

Most popular total knee prosthesis used are cruciate retaining and posterior stabilized. These two different TKA designs are related to two main kinematic problems of knee. The first is paradoxical motion that is an anterior translation of femoral condyles during flexion instead of physiological rollback,the second is reverse screw home that is extra rotation of tibia about 15 degrees on femur during the last 20 degrees of extension and it may cause inferior range of motion and patello femoral instability.

Medial pivot variety of cruciate retaining implant mimics the natural knee kinematics and helps to overcome the above problems. Though outcomes following medial pivot TKA have been compared with TKA using posterior stabilized components in the past, there is scant literature comparing outcomes of TKA using medial pivot versus cruciate retaining prostheses. The aim of this study is to compare clinical and radiological outcomes in the patients following medial pivot cruciate retaining TKA and other cruciate retaining TKA

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients who have undergone primary TKA with following Implants : medial pivot, and other cruciate retaining implants Patients with primary osteoarthritis and varus deformity.

排除标准

  • Patients undergoing TKA for secondary osteoarthritis.
  • Patients who have undergone any prior surgery to the index knee Patients with bleeding diasthesis Patients with pre existing neuropathies.
  • Inflammatory and post traumatic arthritis.
  • Adjoining bone and joint disease.
  • Patients with severe knee deformity who may require specialized implants and an increase in constraint.
  • Patients with other lower limb joint pathology Patients having Hepatic failure Patients having Renal failure.

结局指标

主要结局

Knee society score more than 80

时间窗: Knee society score more than 80 at 6weeks,3months,6months and 1year post operatively.

次要结局

  • Oxford knee score, Knee injury Osteoarthritis index score, forgotten joint society,lower extremity functional scale,Western Ontario and McMaster University Osteoarthritis index,(Hip knee ankle angle,Tibiofemoral Angle, Alpha,beta,gamma,delta angles)

研究者

发起方
Medicover Hospital, hitech City, Hyderabad
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Krishna Kiran Eachempati

Medicover(formerly maxcure)Hospital

研究点 (1)

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