Comparison of Intensive Diet With Knee Arthroplasty for Treatment of Obese Patients With Knee Osteoarthritis: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- The Oxford Knee Score
研究概览
简要总结
This study addresses this question by comparing two recommended and potentially competing strategies in the management of obese knee OA patients:
Strategy A. A 3-months waiting list followed by a 12-week Intensive supervised diet intervention; Strategy B. A 3-months waiting list followed by surgical knee arthroplasty including standard post-operative rehabilitation.
The primary outcome is taken at week 38 from inclusion (baseline) corresponding to 6 months after treatment start (either surgery or intensive diet program).
Outcomes are also taken at baseline, week 13 (before treatment start), week 26 (end of diet program), week 38 (primary endpoint), and week 64.
详细描述
This trial asks a previously unaddressed and important clinical question about management of knee osteoarthritis (OA) patients.
Current recommendations of management of knee OA highlight weight loss as first choice and weight loss is a potential principal intervention against knee OA as a co-morbidity to obesity.
Knee arthroplasty (KA) is an effective treatment of knee OA in patients with pain that limits the patient's ability to perform their normal daily activities. KA is considered a successful orthopedic procedure to alleviate knee pain and disability in end stage knee OA. The demand for KA is large and growing worldwide; in Denmark alone approximately 10,000 KA procedures are performed annually, which pose a substantial economic burden to the health care system. KA carries relatively low risk both in terms of systemic complications and suboptimal outcomes for the joint itself. KA is one of the most effective surgical procedures available with very few contraindications. As a result, the demand from patients for these treatments continues to rise along with the confidence of surgeons to offer KA to a wider range of patients in terms of age, disability and co-morbidities.
However, the quality of evidence for KA efficacy is low as very few randomized controlled trials (RCTs) exist - particularly with respect to comparative effectiveness. To inform decision making for obese individuals with knee OA, it is important to evaluate the comparative effectiveness of a weight loss intervention against KA. The present trial has been designed to compare the effectiveness of weight loss and KA in individuals with obesity and knee OA.
This study addresses this question by comparing two recommended and potentially competing strategies in the management of obese knee OA patients:
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
- Single (Outcomes Assessor)
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
The Oxford Knee Score
时间窗: Week 38 from 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 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. The OKS is short, practical, reliable, valid, and sensitive to clinically important changes over time.
次要结局
- Proportion of participants that meet the OMERACT-OARSI response criteria(Week: 13, 26, 38 and 64 from baseline)
- Change in proportions of participants the use analgesics for knee OA pain.(Week: 13, 26, 38 and 64 from baseline)
- Patient Acceptable Symptom State (PASS)(Week: 13, 26, 38 and 64 from baseline)
- Body weight(Week: 13, 26, 38 and 64 from baseline)
- The EuroQoL Health outcome and quality of life questionnaire (EQ-5D-5L)(Week: 13, 26, 38 and 64 from baseline)
- Timed up-and-go(Week: 13, 26, 38 and 64 from baseline)
- Proportion of participants with Metabolic syndrome(Week: 13, 26, 38 and 64 from baseline)
- The 12 item short form of tge Knee injury and Osteoarthritis Outcome Score (KOOS-12)(Week: 13, 26, 38 and 64 from baseline)
- Patient's global assessment of impact of the knee in daily life (PGA)(Week: 13, 26, 38 and 64 from baseline)
- Proportion of patients who experience minimal important improvement(Week: 13, 26, 38 and 64 from baseline)
研究者
Marius Henriksen
Professor
Frederiksberg University Hospital