Effect of Different Size of Patellar Resurfacing on Patellar Crepitus of the One-stage Bilateral Total Knee Arthroplasty: a Prospective Randomize Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Patella crepitation
研究概览
简要总结
The goal of this study is to compare the incidence of patella crepitation using different size of patella component in bilateral simultaneously total knee arthroplasty with patella resurfacing. The main question is does size of patella component effect the incidence of patella crepitus? In the control group, anatomically sized patella components were used, whereas the intervention group received 3 mm smaller, reduced-size patella components. Participants were scheduled for follow up examination 2 weeks, 6 weeks, 6 months and 1 year for incidence of the patella crepitation and other outcomes.
详细描述
For decades, total knee arthroplasty (TKA) has been the treatment of choice for knee osteoarthritis, with posterior-stabilized (PS) systems showing excellent long-term outcomes. However, patellar crepitus is more common with PS TKA systems because the cam and post mechanism can entrap fibrosynovial tissue within the intercondylar box, causing crepitus or clunking. Patellar crepitus (PC) was defined as an audible grinding noise or palpable vibrations in the knee during active and passive range of motion, detected by the examiner's hand on the patient's patella and sometimes can be audible.
This study was designed as a single-center, prospective randomized controlled trial comparing anatomical and reduced size of patella component in patients who underwent sequential bilateral TKA with patella resurfacing under single anesthesia. All participants were blinded to their intervention. A total of 94 knees from 47 patients were randomly assigned to undergo TKA with an anatomically sized patella component in one knee and reduced-size patella component in another knee or vice versa.
Crepitus, as a primary outcome, was assessed at 2, 6, 24 and 48 weeks follow-up using a validated and standardized approach. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible). Secondary outcomes included anterior knee pain (AKP), Feller's patella score (FPS), Kujala score, knee society score (KSS), range of motion (ROM), radiographic findings, and complications. AKP was measured using a 10-cm visual analog scale (VAS) in 1-cm increments. Knee ROM was measured with a goniometer. Radiographic parameters were measured at 6 months postoperatively.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 80 years.
- •American Society of Anesthesiologists (ASA) Classification 1 or
- •Diagnosed with primary knee osteoarthritis and requires bilateral total knee arthroplasty with patellar resurfacing.
- •Participants can understand and consent to participate in the research project
排除标准
- •Secondary knee osteoarthritis,
- •Previous knee surgery or arthroscopic surgery
- •Individuals who cannot undergo surgery due to underlying medical conditions.
- •BMI > 40 kg/m2
- •Infection around the knee
研究组 & 干预措施
Group 1
干预措施: Anatomical size patella component (Procedure)
Group 2
干预措施: Reduced size patella component (Procedure)
结局指标
主要结局
Patella crepitation
时间窗: From postoperative follow-up 2 weeks to 1 year
Crepitus was assessed at each follow-up using a validated and standardized approach of physical examination. The patient lay supine with relaxed muscles while the examiner passively flexed and extended the knee through a 30-90° range at least three times. Crepitus was graded as: 0 (none), 1 (fine palpable), 2 (coarse palpable), and 3 (audible).
次要结局
- modified Insall salvati ratio(preoperative and follow up 6 months)
- Range of motion(From enrollment (preoperative measurement) to the end of postoperative follow-up (1 year))
- anterior knee pain(follow up 6 months and 12 months)
- Feller's patella score(follow up 6 months and 12 months)
- Knee society score(follow up 6 months and 12 months)
- Kujala score(follow up 6 months and 12 months)
- Posterior tibial slope(preoperative and follow up 6 months)
- modified Patella tendon length(preoperative and follow up 6 months)
- modified Patella height(preoperative and follow up 6 months)
- Posterior femoral offset(preoperative and follow up 6 months)
- Patella tilt(preoperative and follow up 6 months)
- Complication(up to 12 months)
研究者
piya pinsornsak
Professor
Thammasat University
