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临床试验/NCT02540902
NCT02540902Unknown不适用

A Prospective Study of an All Polyethylene Tibial Component Used in Total Knee Arthroplasty Surgery

Golden Jubilee National Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Bone mineral density

研究概览

简要总结

This will be a prospective single cohort investigation of the Columbus all polyethylene tibia (Aesculap AG, Tuttlingen, Germany) used in total knee arthroplasty (TKA) surgery. The aim of the project is to determine post-operative outcome of the all polyethylene tibia up to two years.

详细描述

Thirty consecutive TKA patients under the care of two orthopaedic consultants at the Golden Jubilee National Hospital who meet the inclusion/exclusion criteria will be recruited to the study and will be given the all polyethylene tibia. Participants will return for their standard postoperative followup appointments (6 weeks and 1 year post-operatively). In addition to standard care, a bone density scan using dual energy x-ray absorptiometery (DXA) will be done as part of the 6 weeks post-operative follow-up. A second DXA scan will be done at an additional appointment at the hospital between 18 and 24 months post-operatively for a bone density scan which is not part of standard care.

The data which will be analysed will be the results of the bone scan, computer generated data about the range of movement (RoM) and alignment of the operated knee collected as part of the operation, the RoM, clinical outcome and satisfaction data collected at the pre-operative assessment and post-operative followups, pre- and post-operative x-rays, complications, survivorship and surgeon experience of using the all polyethylene tibia. These data will be investigated to see if the all polyethylene tibia has satisfactory outcomes with no adverse effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unilateral TKA
  • Aged 70 year or older
  • BMI < 37.5
  • Suitable to receive the study implant

排除标准

  • Revision of existing knee replacement
  • Previous lower limb replacement
  • Proximal tibial bone defects
  • Diagnosed osteopenia or osteoporosis
  • Unable to give informed consent
  • Unwilling to take part
  • Unable to return to the Golden Jubilee National Hospital for followup appointments

研究组 & 干预措施

All-poly

Experimental

Knee arthroplasty with all-polyethylene tibia

干预措施: All-polyethylene tibia (Aesculap AG) (Device)

结局指标

主要结局

Bone mineral density

时间窗: 18 to 24 months post-operatively

Measure of peri-prosthetic bone mineral density

次要结局

  • Intra-operative RoM(Intra-operative)
  • EQ-5D(1 year)
  • Patient satisfaction(1 year)
  • Oxford Knee Score(1 year)
  • Leg alignment(1 year)
  • Bone condition(1 year)
  • Surgeon feedback from surgery(intra-operative)
  • Peri-prosthetic lucency(1 year)
  • Intra-operative alignment(Intra-operative)
  • RoM(1 year)
  • Complications(1 year)
  • Implant survivorship(18 to 24 months)
  • Component position(1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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