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临床试验/CTRI/2026/01/100062
CTRI/2026/01/100062尚未招募3 期

A prospective observational study on thirty day post operative complications following primary total knee replacement surgery

Dr. Sumit Tibrewal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年1月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
2011 Knee Society score, Western Ontario and

研究概览

简要总结

Osteoarthritis is a common disorder of the musculoskeletal system that reduces function and quality

of life and is characterized by joint pain, tenderness, crackling, stiffness, varying degrees of local

inflammation and occasional exudate. Osteoarthritis disease is often activity related. Later, during

the course of illness, constant pain becomes a features. Pain in osteoarthritis is not only due to

structural changes in the affected joint, but is the result of the interaction of structural changes,

peripheral and central pain processing mechanisms. However, pain is not the only result of

osteoarthritis. Pain is related to functions, body movement causes pain, and pain results in limitation

of body functions. Joint stiffness is also common, especially in the morning. Auditory and tactile

"cracking" or "grinding" of the joint, as well as a feeling of instability or bending, are common during

active or passive movements, especially in the later stages. This can result from pain, effusion,

capsular contracture, muscle spasm or weakness, loose body in the joint, mechanical restrictions,

and joint deformity/alignment. Dysfunction is another important factor in osteoarthritis. It is often

associated with joint stiffness. Osteoarthritis causes changes in mobility and function. Patients often

experience physical limitations, personal care issues, work capacity, and even household management issues.

Various treatment modalities for osteoarthritis include exercise, transcutaneous electrical nerve

stimulation (TENS), weight control, chondroitin or glucosamine, acetaminophen duloxetine, oral

non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs, opioids, intra-articular injections

(corticosteroids, platelet rich plasma, hyaluronic acid) and surgeries if no relief from above

mentioned options.

The Kellgren and Lawrence (KL) classification has been commonly used to classify osteoarthritis.

The Kellgren and Lawrence classification also assist healthcare providers with a treatment

algorithm to guide clinical decision-making, specifically defining which patients may benefit most

from surgical management. The KL classification was originally described using AP knee

radiographs. Each radiograph was assigned a grade from 0 to 4, which they correlated to increasing

severity of OA, with Grade 0 signifying no presence of OA and Grade 4 signifying severe OA. Grade

0 is No radiographic features of osteoarthritis. Grade 1 is possible joint space narrowing (normal

joint space is at least 2 mm at the superior acetabulum) and osteophyte formation. Grade 2 is

definite osteophyte formation with possible joint space narrowing. Grade 3 is multiple osteophytes,

definite joint space narrowing, sclerosis and possible bony deformity Grade 4 is large osteophytes,

marked joint space narrowing, severe sclerosis and definite bony deformity.

Total knee arthroplasty (TKA) is an effective surgical treatment for arthritis of knee joint. It is

considered to provide significant pain relief and improves knee function in patients with arthritis with

good long-term results. Total Knee arthroplasty, a surgical procedure to replace weight-bearing

surfaces of knee joint to relieve pain and disability; is an end-of-line treatment for patients with

severe pain and functional limitations.

Total knee arthroplasty (TKA) can be associated with early and late complications. Early complications include wound infection, hematoma, thromboembolic events (DVT, pulmonary embolism), neurovascular injury, and stiffness. Prosthesis-related issues include malalignment, instability, patellar tracking problems, and periprosthetic fractures. Late complications involve aseptic loosening, polyethylene wear, osteolysis, and chronic infection. Persistent pain and limited range of motion may affect outcomes. Rare complications include metal hypersensitivity and extensor mechanism disruption. Careful surgical technique, patient optimization, thromboprophylaxis, and infection prevention strategies are crucial to minimize risks and improve long-term function and implant survival after TKA.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing primay Total knee arthroplasty.

排除标准

  • Patient undergoing total knee arthroplasty for hemophilia arthropathy and malignant disease.
  • Patient undergoing revision surgery.
  • Patient undergoing hybrid total knee arthroplasty with all polyethylene tibial components will be excluded from the study.

结局指标

主要结局

2011 Knee Society score, Western Ontario and

时间窗: Scores measured pre operative and post operative at first month

McMaster Universities Osteoarthritis Index

时间窗: Scores measured pre operative and post operative at first month

WOMAC

时间窗: Scores measured pre operative and post operative at first month

次要结局

未报告次要终点

研究者

发起方
Dr. Sumit Tibrewal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sumit Tibrewal

PGIMS Post Graduate Institute of Medical Sciences Rohtak

研究点 (1)

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