Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic

Osteoarthritis, Knee Clinical Trial

Official title:

OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673801
• Other study ID #: 63 00001
• Status: Completed
• Phase: N/A
• First received: January 22, 2016
• Last updated: February 3, 2016
• Start date: August 2015
• Est. completion date: October 2015

Study information

• Verified date: August 2015
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial 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.

Description:

Further description is provided as eligibility criteria and outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Other:
• Orthopedic assessment in the outpatient clinic
Orthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation

Locations

Country	Name	City	State
Denmark	Silkeborg Regional Hospital	Silkeborg

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Kellgren-Lawrence scale	Radiographic grade of osteoarthritis	Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)	No
Other	Treatment plan	Evaluated by the orthopedic surgeon	Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)	No
Other	Earlier treatment	Patient-reported	At baseline	No
Primary	"Relevant" or "Not relevant" for orthopedic assessment	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)	No
Secondary	Knee Injury an Osteoarhtritis Outcome Score (KOOS)	Patient reported symptoms, stiffness, pain, activities of daily living (ADL), function in sport and recreation and knee related quality of life	At baseline	No