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临床试验/CTRI/2024/07/070600
CTRI/2024/07/070600尚未招募不适用

Prospective cohort study for assessment of cutaneous hypoesthesia around knee replacement surgery

Pt. B.D Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年7月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
Calculate the incidence of cutaneous hypoesthesia around knee after primary knee

研究概览

简要总结

All surgeries will be performed by using conventional TKA surgical technique including a midline skin incision and the medial parapatellar approach under regional/general anaesthesia. The length of the skin incision used will be according to exposure needed. The first assessment will be done at two weeks post operatively after stitch removal. All the demographic details, medical history, implant information (type of knee prosthesis, patella resurfacing, use of intramedullary stem etc.), surgical details (tourniquet time, length of scar, type of anaesthesia, intraoperative complication if any etc.), sensory assessment around knee will be recorded at this point. Postoperative complications (wound-healing problems, such as dehiscence, drainage, or necrosis, and venous thrombosis etc.) will be noted. The patients will be further followed up at 1 month, 2 months and 3 months. For the purpose of sensory assessment, the locations of numbness will be grouped into 4 zones with patella being the center: Zone I: Superomedial quadrant Zone II: Superolateral quadrant 14 Zone III: Inferolateral quadrant Zone IV: Inferomedial quadrant sensory assessment will be done using the blunt pin-prick sensation test which is a simple and reliable method to assess numbness. A blunt pin-prick will be performed every 1 cm vertically and horizontally center being midpoint of patella. Margins and locations of skin numbness will be recorded. An area of skin numbness is defined as an area of at least 1 cm2 . Loss of protective sensations will be assessed by a Semmes-Weinstein monofilament size 5.07/10g, which will be applied to the skin with the knee in full extension. The patients will be asked to map out the area of hypoesthesia around knee with skin marker pen. After marking up of the area by the patient a calibrated digital picture of the area marked with knee joint will be taken. Area of hypoesthesia will be calculated by using calibrated picture of the knee in full extension using Image J software18 (US, National Institutes of Health, Bethesda, MD). The FJS-12 (Forgotten joint score) Questionnaire will be filled by asking specific questions from the patients and scores obtained will be used for analysis of the same and its correlation with cutaneous hypoesthesia at final follow up with minimum follow up of 3 months.

研究设计

研究类型
Observational

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 with primary osteoarthritis of the knee who will undergo primary Total knee replacement surgery during the study period will be included.

排除标准

  • Previous knee surgery or having a knee scar, Patients having impaired sensation of the knee from any cause, before Total knee replacement e.g. spinal stenosis, recent spine surgery, peripheral neuropathy, peripheral vascular disease etc, Secondary Osteoarthritis of knee, Patients with a valgus deformity around knee, Severe Varus deformity (more than 20 degree) around knee, Inflammatory arthritis of knee, Revision Total knee replacement patients.

结局指标

主要结局

Calculate the incidence of cutaneous hypoesthesia around knee after primary knee

时间窗: At two weeks, one month, two months and three months minimum

replacement surgery

时间窗: At two weeks, one month, two months and three months minimum

次要结局

  • Evaluate association of various risk factors with cutaneous hypoesthesia(At two weeks, one month, two months & three months minimum)
  • correlation of PROMs (Patient reported outcome measures) {Forgotten Joint Score}[ FJS 12] with cutaneous hypoesthesia(minimum three months after surgery or later)
  • Evaluate early functional outcomes after primary total knee arthroplasty(minimum three months after surgery or later)

研究者

发起方
Pt. B.D Sharma PGIMS Rohtak
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Jitendra Wadhwani

Pt B D S PGIMS, Rohtak

研究点 (1)

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