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