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Intensive Diet vs Knee Arthroplasty for Knee Osteoarthritis

NCT05172843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-02-26

No results posted yet for this study

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

Interventions

PROCEDURE

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.

BEHAVIORAL

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.

Sponsors & Collaborators

  • Marius Henriksen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2024-07-01
Completion
2025-02-24

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05172843 on ClinicalTrials.gov