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Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic

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ClinicalTrials.gov Identifier: NCT02673801
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Central Jutland Regional Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Other: Orthopedic assessment in the outpatient clinic

Detailed Description:
Further description is provided as eligibility criteria and outcome measures.

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Study Type : Observational
Actual Enrollment : 226 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)
Study Start Date : August 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. "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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. Earlier treatment [ Time Frame: At baseline ]
    Patient-reported



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673801


Locations
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Denmark
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Central Jutland Regional Hospital
Investigators
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Principal Investigator: Lone R Mikkelsen, PhD Research physiotherapist
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Responsible Party: Central Jutland Regional Hospital
ClinicalTrials.gov Identifier: NCT02673801    
Other Study ID Numbers: 63 00001
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: August 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data can be provided upon request, for instance for meta-analysis.
Keywords provided by Central Jutland Regional Hospital:
Referral and Consultation
Orthopedics
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases