Non-surgical Treatment of Knee Osteoarthritis - a Comparison of Effects in 2200 Patients

October 16, 2015 updated by: Ole Simonsen, Northern Orthopaedic Division, Denmark

The purpose of this study is to assess whether radiographic osteoarthritis severity (OA; Kellgren-Lawrence scale) is associated with self-reported improvement in pain after non-surgical treatments (physiotherapy, pain killers, injection, other treatments).

The hypothesis is that radiographic OA severity is inversely associated with self-reported improvement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2262

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Department of Orthopedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

2200 patients with knee osteoarthritis not eligible for at total knee arthroplasty

Description

Inclusion Criteria:

  • Not eligible for at total knee arthroplasty

Exclusion Criteria:

  • Ipsilateral knee arthroplasty

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-surgical treatment
Other: Physiotherapy
Drug: Paracetamol and nonsteroidal antiinflammatory drug (NSAID)
Drug: Cortisone Injection
Other: Others

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported improvement
Time Frame: 2-5 years after consulting orthopedic surgeon

Assessed using the question:

Has your pain improved? Response categories: pain free; better; unchanged; worse
2-5 years after consulting orthopedic surgeon

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Study Chair: Michael Rathleff, MSc, Department of Occupational Therapy and Physiotherapy, Aalborg University Hospital, Denmark.
  • Study Chair: Mikkel M Andersen, MSc, Department of Mathematical Sciences, Aalborg University
  • Principal Investigator: Ole Simonsen, MD, DMSc, Department of Orthopedic Surgery
  • Study Chair: Christina A Derosche, BSc, Department of Orthopedic Surgery
  • Study Chair: Signe B Pedersen, Department of Orthopedic Surgery
  • Study Chair: Søren T Skou, MSc, Orthopedic Surgery Research Unit + Department of Health Science and Technology, Aalborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The 07 - 11 cohort

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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