Structured Treatment of Osteoarthritis of the Knee With or Without Total

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Knee osteoarthritis (OA) is the degenerative joint disease that most often requires treatment and at the same time the one associated with the greatest social costs. In addition, the disease has many personal costs and is greatly contributing to reduced functionality and autonomy of older adults.

It is recommended both nationally and internationally that the treatment of knee OA should include multiple treatment modalities. Clinical guidelines recommend that exercise, weight loss and patient education is the first step in treatment and that insoles and pharmacological treatment can be included as a supplement. If this non-surgical treatment is ineffective surgical treatment, especially surgery with insertion of total knee replacement (TKR), may be indicated. There are effects of both non-surgical treatment and TKR, but no studies exist, which examine the effect of surgery with insertion of TKR in addition to the recommended non-surgical treatment of knee OA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01410409
Study type	Interventional
Source	Northern Orthopaedic Division, Denmark
Contact
Status	Completed
Phase	N/A
Start date	September 2011
Completion date	March 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03277066` - A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis	Phase 2
Recruiting	`NCT03090698` - Outcomes of Injections in Patients Waiting for Total Knee Replacement	Phase 4
Completed	`NCT02556710` - A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee	Phase 3
Withdrawn	`NCT02237846` - Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis	Phase 1/Phase 2
Completed	`NCT02242435` - A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis	Phase 3
Completed	`NCT01849445` - Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study	N/A
Completed	`NCT02096393` - Patient Specific Instrumentation in TKR	N/A
Completed	`NCT01704157` - A Prospective Study Evaluating the Treatment of Knee Osteoarthritis With the Cryo-Touch III Device	N/A
Active, not recruiting	`NCT01374230` - Long-Term Multicenter Evaluation of the E1® Tibial Bearing	N/A
Completed	`NCT02156440` - Cross-over Study of the Efficacy and Safety of SierraSil Joint Formula 14 in Osteoarthritis of the Knee	Phase 2
Not yet recruiting	`NCT01270412` - Platelet Rich Plasma (PRP) as a Treatment for Knee Osteoarthritis PRP as a Treatment for Knee Osteoarthritis	Phase 2/Phase 3
Completed	`NCT01207115` - A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee	Phase 2
Completed	`NCT00988091` - Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee	Phase 3
Completed	`NCT00970008` - Exploring Massage Benefits for Arthritis of the Knee	Phase 2
Completed	`NCT01331278` - A Comparative Study of Knee Systems	Phase 4
Completed	`NCT00531427` - Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee	Phase 3
Completed	`NCT00792727` - HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain	Phase 3
Completed	`NCT00449696` - Gel-200 Versus Placebo in Osteoarthritis of the Knee	Phase 3
Completed	`NCT04145011` - Coolief Cooled Radiofrequency vs. Conventional Radiofrequency to Manage OA Knee Pain	N/A
Completed	`NCT01430559` - Effect Of Meloxicam Versus Placebo In Mainland Chinese Patients With Osteoarthritis Of The Knee	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Structured Treatment of Osteoarthritis of the Knee With or Without Total Knee Replacement — MEDIC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms