Clinical trial NCT01535001: Structured Non-operative Treatment of Knee Osteoarthritis
Official title: Structured Non-operative Treatment of Knee Osteoarthritis - a Randomized Controlled Trial of Pain, Physical Function and Quality of Life With 12months Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis, Knee
Treatment Outcome
Time Factors
Rehabilitation
Combined Modality Therapy
Middle Aged
Aged
Aged, 80 and over
Male
Female
Humans
Analysis of Variance
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Rheumatism Association
name: Association of Danish Physiotherapists
First posted: 2012-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.

The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment 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.

Detailed 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 osteoarthritis 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.

However if the patient is not a candidate for total knee replacement, the patient most often receives only information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse. This postponement of treatment can lead to a worsening of pain and function and a worse outcome after treatment. Therefore, the current treatment strategy for the patient group is problematic.

The current practice may be due to the lack of studies with high level of evidence that have examined the optimal non-operative treatment approach and compared it with the current standard treatment for this group of patients.

Eligibility criteria: Inclusion Criteria:

* Knee-OA detected by x-ray (Kellgren \& Lawrence grade 1 or greater)
* KOOS4 of ≤ 75
* Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic surgeon.
* The participant is \> 18 years of age.
* The participant can provide relevant and adequate, informed consent.

Exclusion Criteria:

* Prior TKA ipsilateral
* Rheumatoid arthritis
* Mean VAS \> 60mm the last week on a 0-100mm scale
* Possible pregnancy or planning pregnancy;
* Inability to comply with the protocol;
* Inadequacy in written and spoken Danish.

Primary outcomes:
measure: Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: Primary: 12months.
Secondary outcomes:
measure: Change From Baseline in EQ-5D
timeFrame: Primary: 12months.
measure: Change From Baseline in 20-meter Walk
timeFrame: Primary: 12months.
measure: Change in the Five KOOS Subscale Scores From Baseline
timeFrame: Primary: 12 months.
measure: Weight Change in kg From Baseline
timeFrame: Primary: 12months.
measure: Proportion of Users of Pain Medication
timeFrame: Baseline and 12months.
measure: Number of Serious Adverse Events Reported at Index Knee
timeFrame: Primary: 12months.
measure: Change From Baseline in Time From the Timed Up and Go
timeFrame: Primary: 12 months.
Other outcomes:
measure: Exploratory Outcomes
timeFrame: Baseline, 3months, 6months, 12months and 24months
Locations:
city: Aalborg
country: Denmark
facility: Department of Occupational and Physiotherapy, Aalborg Hospital-Aarhus University Hospital
city: Farsø
country: Denmark
facility: Farsoe Hospital
city: Frederikshavn
country: Denmark
facility: Vendsyssel Hospital, Frederikshavn
Study officials:
affiliation: Orthopaedic Research Unit, Aalborg University Hospital, Denmark
name: Søren T. Skou, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark
name: Ewa M. Roos, PhD
role: STUDY_CHAIR
affiliation: Center for Sensory-Motor Interaction (SMI), Department of Health Sciences and Technology, Aalborg University
name: Lars Arendt-Nielsen, Dr.Sci.Med.
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Mogens B. Laursen, PhD
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Sten Rasmussen, M.D.
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Michael S. Rathleff, PhD-student
role: STUDY_CHAIR
affiliation: Orthopaedic Surgery Research Unit, Aalborg University Hospital, Denmark
name: Ole H. Simonsen, Dr.Sci.Med.
role: STUDY_CHAIR
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