Comparison of Cobalt-Chromium (CoCr) Alloy and Titanium-Nitride (TiN) Coating in Total Knee Arthroplasty: A Prospective, Randomised, Double-blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change of Postoperative functional outcome - Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
In the current prospective, randomized study, two different materials of the same total knee arthroplasty (TKA) system - cobalt-chromium (CoCr) and titanium-nitride (TiN) - are going to be compared with regards to postoperative outcome. Two-hundred patients are planned to be included in the study over a 4-year period, randomly assigned to either the CoCr- or TiN-implant-group. In order to ensure double-blinding, patients will not be informed about the group they had been assigned to. Moreover, no identifying information of the implant used will be written on documents later accessible to nurses and/or physicians at follow-up appointments. Consequently, surgeons of the respective patients will be excluded from study-specific examination of patients. Despite range of motion (ROM), questionnaires (visual analogue scale - VAS; Western Ontario and McMaster Universities Osteoarthritis Index - WOMAC, Forgotten Joint Score - FJS; Knee Society Scoe - KSS) will be used to assess the postoperative outcome. Furthermore, metal ion levels (cobalt, chrom, molybdenum, titanium) in the blood stream of patients will be measured at scheduled follow-up appointments. It is expected that there will not be a measureable difference between the two coating-groups with regards to ROM, functionality, and metal-ion levels over time.
详细描述
Rationale
The present double-blinded study was planned in order to assess whether differences in materials - using one otherwise similar TKA system - would have an effect on postoperative patient outcome. Moreover, metal ion levels will be measured in the blood stream preoperatively (as reference) and upon follow-up, based on previous observations that metal ion levels are increased in serum following TKA, without any relevant influence on outcome.
Aims
The aim of the present prospective study is to assess whether differences in tribological pairings - i.e. TiN-coating in comparison to CoCr-alloy using a frequently implanted total knee endoprosthesis (ACS® System, Implantcast GmbH, Buxtehude, Germany) - have an effect on postoperative range of motion (ROM) and patient satisfaction, reflected by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score (FJS), Knee Society Score (KSS), Visual Analogue Scale (VAS). Moreover, metal ion levels will be tested in both groups to monitor their concentration in the blood stream, usually reflecting physiological abrasion.
Endpoints
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
Masking of both patients and outcome assessors. Only care provider (i.e. surgeon) and investigator aware of implant-type used. During follow-up, neither care provider nor investigator allowed to assess patients' study-specific outcome. As implants look identical on X-rays, allocation to one or another group cannot be verified by independent outcome assessors.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee osteoarthritis of index knee
- •Varus angle < 15° of index knee
排除标准
- •Previous native knee infection of index knee
- •Previous distal femoral fracture of index knee
- •Previous proximal tibial fracture of index knee
- •Preceding osteotomy of index knee
- •Known allergies against metals, drugs, organic substances
- •Unicondylar prosthetic replacement of index knee
- •Knee osteoarthritis of both joints with planned simultaneous TKA
结局指标
主要结局
Change of Postoperative functional outcome - Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Preoperatively, postoperative week 6, month 12, month 24, month 60.
Assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC). This index ranges from 0 to 100 points and is based on items pain, physical function and joint stiffness. Lower values indicating better outcomes, whilst higher values point towards worse outcome. Higher scores on the WOMAC indicate a worse outcome
Change of Postoperative functional outcome - ROM with goniometer
时间窗: Preoperatively, postoperative week 6, month 12, month 24, month 60.
Range of motion (ROM), assessed with goniometer approved for medical issues
Change of Postoperative functional outcome - Knee Society Score (KSS)
时间窗: Preoperatively, postoperative week 6, month 12, month 24, month 60.
Knee society score (KSS) is built up by two scores, i.e. "Functional Score" (3 items) and "Knee Score" (7 items), both ranging from 0 to 100 points. The lower the values, the worse the outcome.
Change of Postoperative functional outcome - pain
时间窗: Preoperatively, postoperative week 6, month 12, month 24, month 60.
VAS score (Visual Analogue Scale; 0 = no pain, 10 = severe pain)
Change of Postoperative functional outcome - FJS
时间窗: Preoperatively, postoperative week 6, month 12, month 24, month 60.
Forgotten Joint Score (FJS) with a scale ranging from 0 to 100, where a high value indicates a better outcome
次要结局
- Change of Metal ion levels in blood stream(Preoperatively, month 6, month 12, month 24, month 60.)