Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic

February 3, 2016 updated by: Central Jutland Regional Hospital

OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)

The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. This will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Further description is provided as eligibility criteria and outcome measures.

Study Type

Observational

Enrollment (Actual)

226

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
      • Silkeborg, Denmark, 8600
        • Silkeborg Regional Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis

Description

Inclusion Criteria:

  • All patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis.

Exclusion Criteria:

  • Cognitive or language problems that precludes the filling in of the questionnaires
  • Unwillingness to answer the questionnaires
  • Patients with rheumatoid arthritis, neurological diseases or cancer

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
Patient referred to orthopedic clinic
Orthopedic assessment in the outpatient clinic as well as a new algorithm (using patient-reported symptoms and radiographic evaluation) will be applied
Other: Orthopedic assessment in the outpatient clinic
Orthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Relevant" or "Not relevant" for orthopedic assessment
Time Frame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Results from the algorithm as well as radiographs and the clinic examination
Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury an Osteoarhtritis Outcome Score (KOOS)
Time Frame: At baseline
Patient reported symptoms, stiffness, pain, activities of daily living (ADL), function in sport and recreation and knee related quality of life
At baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kellgren-Lawrence scale
Time Frame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Radiographic grade of osteoarthritis
Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Treatment plan
Time Frame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Evaluated by the orthopedic surgeon
Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Earlier treatment
Time Frame: At baseline
Patient-reported
At baseline

Collaborators and Investigators

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

Sponsor

Central Jutland Regional Hospital

Investigators

  • Principal Investigator: Lone R Mikkelsen, PhD, Research physiotherapist

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

August 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 22, 2016

First Submitted That Met QC Criteria

February 3, 2016

First Posted (Estimate)

February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 63 00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be provided upon request, for instance for meta-analysis.

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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