NCT02673801

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
Last Updated

February 4, 2016

Status Verified

August 1, 2015

Enrollment Period

2 months

First QC Date

January 22, 2016

Last Update Submit

February 3, 2016

Conditions

Keywords

Referral and ConsultationOrthopedics

Outcome Measures

Primary Outcomes (1)

  • "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)

Secondary Outcomes (1)

  • Knee Injury an Osteoarhtritis Outcome Score (KOOS)

    At baseline

Other Outcomes (3)

  • Kellgren-Lawrence scale

    Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)

  • Treatment plan

    Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)

  • Earlier treatment

    At baseline

Study Arms (1)

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

Interventions

Orthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation

Patient referred to orthopedic clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Lone R Mikkelsen, PhD

    Research physiotherapist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 4, 2016

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

February 4, 2016

Record last verified: 2015-08

Data Sharing

IPD Sharing
Will not share

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

Locations