Generalizability of Overweight Patients With Knee Osteoarthritis Awaiting Knee Surgery Accepting to Join a Weight Loss Randomized Trial: Protocol for a Cross-sectional Study Comparing Baseline Characteristics and Propensity of Patients Accepting/Declining Enrolment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Oxford knee score
研究概览
简要总结
The objective of this study is to compare baseline characteristics of overweight knee OA patients accepting vs. declining enrolment in the INKA trial (NCT05172843) to explore if enrolled patients differ systematically from the declining participants with respect to both measured as well as unmeasured baseline characteristics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or more
- •A clinical and radiological diagnosis of knee OA
- •BMI ≥ 30 kg/m2
- •Motivated for weight loss as by the provided program
- •Signed informed consent.
排除标准
- •The scheduled surgery is for revision of an existing prosthesis
- •Planned surgery for more than one knee within the observation period
- •KA indication due to sequelae of fracture(s)
- •Injection of medication or substances in the target knee within 3 months prior to participation
- •Immuno-inflammatory arthritis as cause of the knee OA
- •Current systemic treatment with glucocorticoids equivalent to > 7.5 mg of prednisolone/day
- •Previous or planned obesity surgery
- •Inability to understand or read Danish incl. instructions and questionnaires
- •Any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.
结局指标
主要结局
Oxford knee score
时间窗: Baseline
The Oxford Knee Score (OKS) is a 12-item Patient Reported Outcome questionnaire developed specifically to assess the patient's perspective on the outcomes of knee arthroplasty (KA) with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated that ranges from 0 and 48, with 48 indicating the best outcome.
次要结局
- The Knee Injury and Osteoarthritis Outcome Score - 12 item short form (KOOS-12)(Baseline)
- Brief Illness perception questionnaire (B-IPQ)(Baseline)
- Health outcome and quality of life survey (EQ-5D-5L)(Baseline)
- Analgesic use(Baseline)
- Patient's global assessment of impact of the knee in daily life (PGA)(Baseline)
- Body weight(Baseline)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital