NCT01410409: MEDIC

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement. A Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up

Completed NA Results posted Last updated 14 September 2017

What this trial tests

NA trial testing Neuromuscular training (NEMEX-TJR) in Osteoarthritis of the Knee in 100 participants. Completed in 1 March 2015.

Timeline

1 September 2011

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	Northern Orthopaedic Division, Denmark
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 September 2011
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	3 locations across Denmark

Drugs / interventions tested

• Neuromuscular training (NEMEX-TJR)
• Paracetamol (Paracetamol) — full drug profile →
• Burana — full drug profile →
• Pantoprazol — full drug profile →
• Dietary counseling
• Patient education — full drug profile →
• TKR
• Insoles

Conditions studied

• Osteoarthritis of the Knee — all drugs for Osteoarthritis of the Knee →

Sponsor

Northern Orthopaedic Division, Denmark — full company profile →

Who can join

Eligibility, any sex, with Osteoarthritis of the Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in KOOS4 From Baseline (Knee Injury and Osteoarthritis Outcome Score)
  Time frame: Primary: 12months.
  The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best). Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. Between group comparisons of treatment effect (change in KOO

Sponsor's own description

The purpose of this study is to test whether surgical insertion of total knee replacement provides further improvement in quality of life, pain and function in addition to an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, NSAIDs and Pantoprazol in patients with knee OA, collectively called the MEDIC-treatment(Medicine Exercise Diet Insoles Cognitive).

The H1-hypothesis is that surgery with insertion of TKR in addition to the MEDIC-treatment results in a greater increase in quality of life and functional capacity and greater reduction in pain than the MEDIC- treatment alone at the primary endpoint, which is follow-up 12months after the start of the treatment.

See statistical analysis plan available under "Links" for further description of the study.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized, Controlled Trial of Total Knee Replacement.
   Skou ST, Roos EM, Laursen MB, Rathleff MS, et al · · 2015 · cited 504× · PMID 26488691 · DOI 10.1056/nejmoa1505467
2. Total knee replacement and non-surgical treatment of knee osteoarthritis: 2-year outcome from two parallel randomized controlled trials.
   Skou ST, Roos EM, Laursen MB, Rathleff MS, et al · · 2018 · cited 123× · PMID 29723634 · DOI 10.1016/j.joca.2018.04.014
3. Cost-effectiveness of total knee replacement in addition to non-surgical treatment: a 2-year outcome from a randomised trial in secondary care in Denmark.
   Skou ST, Roos E, Laursen M, Arendt-Nielsen L, et al · · 2020 · cited 19× · PMID 31948990 · DOI 10.1136/bmjopen-2019-033495
4. Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study).
   Skou ST, Roos EM, Laursen MB, Rathleff MS, et al · · 2012 · cited 16× · PMID 22571284 · DOI 10.1186/1471-2474-13-67
5. Knee Confidence as It Relates to Self-reported and Objective Correlates of Knee Osteoarthritis: A Cross-sectional Study of 220 Patients.
   Skou ST, Rasmussen S, Simonsen O, Roos EM. · · 2015 · cited 12× · PMID 26304646 · DOI 10.2519/jospt.2015.5864