Intensive Diet vs Knee Arthroplasty for Knee Osteoarthritis

NCT ID: NCT05172843

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-13
• Study Completion Date: 2025-02-24

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Knee Arthroplasty

Surgical knee replacement using either total knee replacement (TKA) or unicompartmental knee replacement (UKA)

Group Type: ACTIVE_COMPARATOR

Surgical knee arthroplasty

Intervention Type: PROCEDURE

Surgery will be performed 3 months from inclusion in the trial (at week 13). The procedure and type of prosthesis and postoperative program will be at the discretion of the involved surgeon and the participating department.

Post-surgical care and rehabilitation will follow current clinical standards.

Supervised weight loss program

The supervised intensive dietary weight loss program with meal replacements

Group Type: EXPERIMENTAL

Supervised weight loss

Intervention Type: BEHAVIORAL

The supervised intensive dietary weight loss program will be initiated 3 months from inclusion in the trial (at week 13) and lasts for 12 weeks.

The program includes full meal replacement by a standard liquid energy intake in a supervised dietary program. Participants will attend the nutrition department weekly. They will be weighed on a decimal scale, given nutritional and dietetic instructions by an experienced dietitian and formula diet products are handed in sessions of 1-2 h. The participants will be taught to make diet plans.

Following the 12 weeks intensive dietary weight loss program participants will be scheduled for two booster follow-up sessions with a dietician at weeks 39 and 51.

Interventions

Surgical knee arthroplasty

Surgery will be performed 3 months from inclusion in the trial (at week 13). The procedure and type of prosthesis and postoperative program will be at the discretion of the involved surgeon and the participating department.

Post-surgical care and rehabilitation will follow current clinical standards.

Intervention Type: PROCEDURE

Supervised weight loss

The supervised intensive dietary weight loss program will be initiated 3 months from inclusion in the trial (at week 13) and lasts for 12 weeks.

The program includes full meal replacement by a standard liquid energy intake in a supervised dietary program. Participants will attend the nutrition department weekly. They will be weighed on a decimal scale, given nutritional and dietetic instructions by an experienced dietitian and formula diet products are handed in sessions of 1-2 h. The participants will be taught to make diet plans.

Following the 12 weeks intensive dietary weight loss program participants will be scheduled for two booster follow-up sessions with a dietician at weeks 39 and 51.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marius Henriksen

OTHER

Sponsor Role: lead

Responsible Party

Marius Henriksen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The Parker Institute, Frederiksberg Hospital

Copenhagen, , Denmark

Countries

Denmark

Other Identifiers

APPI2-OA-2021-01

Identifier Type: -

Identifier Source: org_study_id