A Prospective, Randomised Internal Pilot Study Investigating the Use of Metaphyseal Cones Versus a Cemented Stem Construct in Revision Total Knee Replacement in Patients With Anderson Orthopaedic Research Institute Grade 2 Defects- a Comparison of Clinical, Functional and Radiological Outcome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- An assessment of compliance with the study protocol
研究概览
简要总结
Lay Person's Summary:
Knee replacement surgery has been successfully carried out for many years. However, in time, some knee replacements will fail-usually either because of wear or loosening of the replacement parts. This may mean the patient has to undergo further surgery-this is known as revision total knee replacement (rTKR). This revision surgery is often more complex than the original operation and presents the operating surgeon with several technical challenges. Of particular concern, is that when the old knee replacement is removed, a large cavity can be left in the bone. The new knee replacement has to be placed into this, but it is essential that it is immediately stable and secure. The large cavity has to be somehow either filled in or bypassed to ensure the new knee replacement is secure enough for early weight-bearing and long term survival.
Different techniques have been used for many years to overcome this problem. Firstly, it may be possible to simply cement another knee replacement into the cavity- probably needing more cement than was previously used.
An alternative option to this is use a device called a "cone" which sits into the bony cavity created by removing the original knee replacement, and a new knee replacement can be cemented into this.
Bone grows onto the cone to ensure its stability. The new knee replacement can have either short stemmed components like the original Total Knee Replacement (TKR), or long stemmed components.
All of these types of rTKR are presently in use throughout the United Kingdom (UK). At this point in time, no-one knows which type is best. The research team are planning to run this study to see if it is possible to identify which type of rTKR gives the best outcome for patients. The research team will examine the results in different ways including questionnaires to measure how well the patients feel their knee is performing, specific tests to measure knee function, and by using x-rays and scans.
The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the research team will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation.
The investigators will identify patients suitable for inclusion in the study from their medical notes, x-rays and scans. If patients consent to be in the study, the investigators will randomly allocate them to receive one of the 3 rTKR options (no cone and new knee replacement only, cone with short stemmed components or cone with long stemmed components) and monitor their progress for 5 years after the operation.
A preliminary analysis of the data generated by the study will be carried out 2.5 years after recruitment of the 1st participant to assess compliance with the study protocol.
详细描述
Methodology:
A randomised, prospective internal pilot study is to be set up to compare the results of different ways of approaching revision Total Knee Replacement (rTKR). The invsetigators will examine 3 differing ways of treating patients undergoing this procedure who present with a grade 2 Anderson Orthopaedic Research Institute (AORI) bony defect. One arm of the study will be randomised to receive a long or short stemmed cemented prosthesis (according to intra-operative findings and surgeon decision at that time), another to receive a metaphyseal cone into which a short stemmed prosthesis will be cemented (</=50mm) and a third arm to receive a metaphyseal cone with a long stemmed cemented prosthesis (>/=100 mm). The study will be carried out in the operating theatres, orthopaedic out-patients department and the physiotherapy department at the Royal Devon and Exeter (RD+E) Hospital.
Patients will be invited to take part in the study in one of 2 ways. Firstly, by their surgeon when they are initially listed for rTKR surgery at their out-patient consultation at the RD+E Hospital. Alternatively, if identified from the current surgical waiting list as suitable for inclusion. In this latter case, potential participants will be contacted by letter by their surgeon asking for permission for one of the research team to approach them to discuss the study. Patients who agree to enter the trial will be divided at random to enter the different treatment arms of the study.
Randomisation will be carried out using a computer generated random number assignment list. 51 patients will be initially included with allocation to either arm of the trial by drawing appropriately marked slips of paper from an opaque envelope. The operating surgeon will not be able to read the slips before they are drawn, nor will they perform the randomisation which will be carried out by one of the investigators not carrying out the surgery on the individual patient.
The research team will undertake a preliminary analysis of the study data 6 months after 51 participants have been recruited (i.e. 2.5 years after 1st patient recruited). This will be to see if the pilot study aims and objectives and study progression rules have been met. Based on this analysis, the aim is to recruit further participants to the number recommended in the preliminary analysis.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to study arm allocation. The physiotherapists performing the functional assessments will be blinded to study arm allocation. T
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing first time revision knee replacement for aseptic loosening or wear of the components
- •Patient has signed an ethics committee approved consent form
- •rTKR to be performed at The Royal Devon and Exeter Hospital
- •AORI class 2 defects of femur and/or tibia
- •Skeletally mature male or female
- •Patient is willing and able to comply with postoperative scheduled clinical and radiological evaluations and rehabilitation
- •Patient must be suitable for a rTKR with the Triathlon TS system i.e. must not have gross collateral ligament laxity
排除标准
- •Refusal to consent to participate in the study
- •Patients known to have an infected joint replacement prior to revision surgery
- •Patients identified with an unexpected infected joint replacement identified per-operatively
- •AORI class 1 defects of tibia or femur where metaphyseal cone fixation is not indicated
- •AORI class 3 defects of tibia and femur where distal femoral replacement or proximal tibial replacement is required.
- •Cases of ligamentous instability where condylar knee revision is not indicated
- •Patient is diagnosed with a systemic disease or metabolic disorder leading to progressive bone deterioration
- •Patient has a neuromuscular or neurosensory deficiency
- •Patients undergoing patella revision in isolation
- •Pregnancy
结局指标
主要结局
An assessment of compliance with the study protocol
时间窗: 2.5 years after recruitment of 1st subject
For this, the research team will measure compliance of study participants with the pre and post-operative attendance schedule
次要结局
- PROMS KOOS 5(60 months post-op)
- PROMS OKS 3(12 months post-op)
- An analysis of the Minimally Clinically Important Difference results from the EQ5D between the 3 arms of the study.2(5 years after surgery)
- PROMS OKS 1(3 months post-op)
- PROMS OKS 2(6 months post-op)
- PROMS OKS 5(60 months post-op)
- PROMS HADS 5(60 months post-op)
- An analysis of the Minimally Clinically Important Difference results from the EQ5D between the 3 arms of the study.1(2 years after surgery)
- DEXA scan(60 months post op)
- PROMS KOOS 2(6 months post-op)
- PROMS OKS 4(24 months post-op)
- PROMS HADS 1(3 months post-op)
- PROMS HADS 3(12 months post-op)
- The assessment of early stability of the newly implanted prosthesis as measured radiographically on x-rays by subsidence(60 months post-op)
- CT scan(6 months post op)
- PROMS KOOS 1(3 months post-op)
- An assessment of numbers recruited to the study by comparing the potential number of recruits to those actually recruited(2 years after recruitment of 1st subject)
- Failure for any reason requiring further revision surgery: including but not exclusive to loosening of the components, infection, instability or pain.(From day 1 post-op to 5 years post -op)
- PROMS KOOS 3(12 months post-op)
- PROMS KOOS 4(24 months post-op)
- PROMS HADS 2(6 months post-op)
- PROMS HADS 4(24 months post-op)