NCT05172843Completed
Intensive Diet vs Knee Arthroplasty for Knee Osteoarthritis
Comparison of Intensive Diet With Knee Arthroplasty for Treatment of Obese Patients With Knee Osteoarthritis: a Randomized Trial
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 92 (actual)
- First submitted
- 13 Dec 2021
- Start date
- 13 Jan 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Marius Henriksen
- Diseases
- Obesity
- NCT number
- NCT05172843
What you commit to
- Study type: Interventional
- Participants enrolled: 92
- From 13 Jan 2022 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The scheduled surgery is for revision of an existing prosthesis
- Planned surgery for more than one knee within the observation period
- Injection of medication or substances in the target knee within 3 months prior to participation
- Current systemic treatment with glucocorticoids equivalent to \> 7.5 mg of prednisolone/day
- Previous or planned obesity surgery
Other illness
- 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.
Other
- KA indication due to sequelae of fracture(s)
- Immuno-inflammatory arthritis as cause of the knee OA
- Inability to understand or read Danish incl. instructions and questionnaires
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Parker Institute, Frederiksberg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
- Intensive diet or knee arthroplasty for severe knee osteoarthritis: The inka randomised trial.Osteoarthritis Cartilage · 2026 · PMID 42431586
This page is information, not medical advice. Discuss any trial with your doctor.