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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02672046
Other study ID # 6300002
Secondary ID
Status Completed
Phase N/A
First received January 20, 2016
Last updated May 11, 2017
Start date January 2016
Est. completion date June 2016

Study information

Verified date January 2016
Source Central Jutland Regional Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate an algorithm to screen patients with a possibility of meniscal injury referred to a sports injury outpatient clinic by using patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients are deemed relevant to undergo assessment by a physician (i.e. in case the patient need to undergo surgery) and which patients are relevant to undergo assessment by a physiotherapist. This will be evaluated by estimating the sensitivity of the new algorithm compared to actual relevancy based on the traditional clinical assessment of the patients.


Description:

According to current practice, patients referred to the Clinic of Sports Injuries will be assessed by either a physician or a physiotherapist. Current practice will continue unchanged during this study.

Before the scheduled assessment, patients will be asked to fulfill a questionnaire including KOOS, a further description of symptoms, previous treatment by physiotherapist and expected upcoming treatment (i.e. surgery or referral to physiotherapist).

An algorithm based on the self-reported information will be used to categorize whether the patient are considered relevant to be referred to assessment by a physician or to assessment by a physiotherapist.

After clinical assessment of the patient, the physician or physiotherapist does a registration of diagnosis, choice of treatment and complexity. Based on choice of treatment and complexity, the patient will be categorized as either relevant to be referred to assessment by a physician or to assessment by a physiotherapist. This categorization is by definition considered correct.

The ability of the algorithm will be evaluated by comparing it's categorization to the correct result. Sensitivity will be estimated.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 35 Years and older
Eligibility Inclusion Criteria:

- Patients above the age of 35 referred to the Clinic of Sports Injuries with knee symptoms

Exclusion Criteria:

- Cognitive or language problems that precludes the filling of the questionnaires

- Previous surgery in the knee

- Symptoms only located in the anterior part of the knee

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment at the Clinic of Sports Injuries
Assessment at the Clinic of Sports Injuries as well as a new algorithm (using patient-reported symptoms will be applied

Locations

Country Name City State
Denmark Silkeborg Regional Hospital Silkeborg

Sponsors (2)

Lead Sponsor Collaborator
Central Jutland Regional Hospital University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Choice of treatment Referral to physical therapy, surgery, information and advice, other Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)
Primary "Relevant referral to assessment by physician" or "Relevant referral to assessment by physiotherapist" Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)
Secondary Knee Injury and Osteoarthritis Outcome Score (KOOS) At baseline
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