Clinical trial NCT05172843: Intensive Diet vs Knee Arthroplasty for Knee Osteoarthritis
Official title: Comparison of Intensive Diet With Knee Arthroplasty for Treatment of Obese Patients With Knee Osteoarthritis: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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:

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.

Although a trial to address this question is needed, so far this study has not been carried out, presumably because trials in routine clinical practice are quite expensive and health care professionals (HCPs) responsible for delivery of either strategy have little incentive to compare KA to less expensive, non-surgical therapies. Moreover, the Danish Health and Medicines Authority have not required such comparisons. Since the Danish healthcare system already provides KA at public hospitals, it appears that such settings are ideally suited to address this question and, in the process, help clinicians around the world make better judgments for their patients with OA.

The sparse comparative effectiveness evidence that could inform clinical decision making, combined with existing evidence from RCTs and observational studies on knee surgery and weight loss provide a clear-cut ethical and scientific justification for the trial described in this protocol.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or more
2. A clinical and radiological diagnosis of knee OA
3. BMI ≥ 30 kg/m2
4. Motivated for weight loss as by the provided program
5. Signed informed consent.

Exclusion Criteria:

1. The scheduled surgery is for revision of an existing prosthesis
2. Planned surgery for more than one knee within the observation period
3. KA indication due to sequelae of fracture(s)
4. Injection of medication or substances in the target knee within 3 months prior to participation
5. Immuno-inflammatory arthritis as cause of the knee OA
6. Current systemic treatment with glucocorticoids equivalent to \> 7.5 mg of prednisolone/day
7. Previous or planned obesity surgery
8. Inability to understand or read Danish incl. instructions and questionnaires
9. 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.

Primary outcomes:
measure: The Oxford Knee Score
timeFrame: Week 38 from baseline
Secondary outcomes:
measure: The EuroQoL Health outcome and quality of life questionnaire (EQ-5D-5L)
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Proportion of participants with Metabolic syndrome
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Change in proportions of participants the use analgesics for knee OA pain.
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: The 12 item short form of tge Knee injury and Osteoarthritis Outcome Score (KOOS-12)
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Patient's global assessment of impact of the knee in daily life (PGA)
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Timed up-and-go
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Patient Acceptable Symptom State (PASS)
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Proportion of patients who experience minimal important improvement
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Proportion of participants that meet the OMERACT-OARSI response criteria
timeFrame: Week: 13, 26, 38 and 64 from baseline
measure: Body weight
timeFrame: Week: 13, 26, 38 and 64 from baseline
Other outcomes:
measure: Change in number of steps per day
timeFrame: baseline and week 13, 26, 38 and 64
measure: Assessment of glycemic control by plasma levels of glucose
timeFrame: baseline and week 13, 26, 38 and 64
measure: Assessment of glycemic control by plasma levels of glycated hemoglobin (glycohemoglobin, HbA1c)
timeFrame: baseline and week 13, 26, 38 and 64
measure: Plasma levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides
timeFrame: baseline and week 13, 26, 38 and 64
measure: Systolic and diastolic blood pressure
timeFrame: baseline and week 13, 26, 38 and 64
measure: Fat mass and lean body mass
timeFrame: baseline and week 38 and 64
measure: Brief Illness perception questionnaire (B-IPQ)
timeFrame: baseline and week 13, 26, 38 and 64
Locations:
city: Copenhagen
country: Denmark
facility: The Parker Institute, Frederiksberg Hospital
Study officials:
References: