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临床试验/NCT05800457
NCT05800457招募中不适用

The Role of Synovectomy in Pain Reduction Among Osteoarthritis Patients Following Total Knee Arthroplasty

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Patients' self-reported level of pain

研究概览

简要总结

Osteoarthritis (OA) is the most common joint disease, causing severe pain due to joint inflammation (synovitis). While total knee arthroplasty (TKA) is commonly performed to reduce pain, 20% of patients are dissatisfied with their outcome post-surgery. This dissatisfaction is caused by persistent pain post-TKA due to synovitis that is not routinely removed during surgery. To address this problem, a synovectomy can be performed during TKA, which involves resecting the inflamed layer of tissue lining the joint, called the synovium, and its associated sensory nerve endings. Since the synovium will regenerate in the months post-surgery, synovectomy only transiently reduces pain after TKA. The proposed study will help ascertain the benefits and effects of synovectomy in patients who are more likely to experience poor satisfaction (driven mostly by pain) post-TKA. This study will include 62 patients undergoing TKA due to end-stage OA who have moderate to severe synovitis, as determined by ultrasound assessment. Patients will be randomized (1:1) to undergo a TKA with synovectomy or without synovectomy. Primary and secondary outcomes will be assessed through patient-reported levels of pain and function, results from physical performance tests, and quality of life (QOL) scores. These measures will be recorded pre- and post-surgery for comparison. Through demonstrating that synovectomy can at least transiently reduce pain post-TKA, this study will provide evidence for the development of medical therapies that target the synovium to slow its regrowth. This will be transformative for the long-term management of joint pain and synovitis post-surgery, thus significantly improving patients' overall QOL.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
41 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females over the age of 40 diagnosed with knee osteoarthritis
  • Scheduled for first unilateral total knee arthroplasty
  • Moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment
  • Referred to the Pre-Admission Clinic at University Hospital

排除标准

  • Bilateral, uni-compartmental, or revision total knee arthroplasty
  • Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
  • Known inflammatory arthropathy, another rheumatic disease, or disease-modifying anti-rheumatic drug (DMARD) use (e.g. methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, TNF inhibitors, etc.) - note: Gout is NOT an exclusion
  • Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date
  • Cannot read, write, or understand English (printed instructions are provided in English only)
  • Any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.).
  • Cognitive impairment or psychological problems that preclude the ability to understand instructions
  • Not able to follow up at routine standard of care post-operative visits

研究组 & 干预措施

Total knee replacement with partial synovectomy

Experimental

Patients in this arm will undergo partial synovectomy during total knee replacement surgery.

干预措施: Partial synovectomy (Procedure)

Total knee replacement without partial synovectomy

No Intervention

Patients in this arm will not undergo partial synovectomy during total knee replacement surgery.

结局指标

主要结局

Patients' self-reported level of pain

时间窗: 12 weeks post-surgery

Pain will be measured using the pain sub-scale (nine items) of the Knee injury and Osteoarthritis Outcome Score (KOOS). Each question on the KOOS is a self-administered questionnaire is assigned a score from zero (no problems) to four (extreme problems) using a five-point Likert scale. The average of each sub-scale is calculated independently. Sub-scale scores range from zero (minimum), indicating severe knee problems, to 100 (maximum), indicating no knee problems (therefore, a higher score is better). The KOOS has demonstrated face validity and construct validity, as well as excellent test-retest reliability for each domain. It has also shown to be responsive to change in patients with knee OA.

次要结局

  • Patients' self-reported quality of life(6, 12, 18, and 24 weeks post-surgery)
  • Inflammation(Ultrasound: Before surgery, 3 and 6 months post-surgery, Samples: Intra-operatively)
  • Joint function - 30-Second Sit to Stand Test(6, 12, 18, and 24 weeks post-surgery)
  • Activities of daily living sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)(6, 12, 18, and 24 weeks post-surgery)
  • Knee-related quality of life sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)(6, 12, 18, and 24 weeks post-surgery)
  • Symptoms sub-scale of the Knee injury and Osteoarthritis Outcome Score (KOOS)(6, 12, 18, and 24 weeks post-surgery)
  • Joint function - Timed Up and Go Test(6, 12, 18, and 24 weeks post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Lanting

Orthopaedic Surgeon, Principal Investigator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (2)

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