Intensive Diet vs Knee Arthroplasty for Knee Osteoarthritis

NCT05172843 | Completed

• 1 other identifier: APPI2-OA-2021-01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• The Oxford Knee Score

  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.

  Week 38 from baseline

Secondary Outcomes (10)

• The EuroQoL Health outcome and quality of life questionnaire (EQ-5D-5L)

  Week: 13, 26, 38 and 64 from baseline

• Proportion of participants with Metabolic syndrome

  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

• 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

Other Outcomes (7)

• Change in number of steps per day

  baseline and week 13, 26, 38 and 64

• Assessment of glycemic control by plasma levels of glucose

  baseline and week 13, 26, 38 and 64

• Assessment of glycemic control by plasma levels of glycated hemoglobin (glycohemoglobin, HbA1c)

  baseline and week 13, 26, 38 and 64

Study Arms (2)

Knee Arthroplasty

ACTIVE COMPARATOR

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

Procedure: Surgical knee arthroplasty

Supervised weight loss program

EXPERIMENTAL

The supervised intensive dietary weight loss program with meal replacements

Behavioral: Supervised weight loss

Interventions

Surgical knee arthroplasty 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.

Knee Arthroplasty

Supervised weight loss 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.

Supervised weight loss program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 29, 2021
• Study Start: January 13, 2022
• Primary Completion: July 1, 2024
• Study Completion: February 24, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

DK (1)