NCT02672046

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 12, 2017

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 20, 2016

Last Update Submit

May 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • "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 Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    At baseline

Other Outcomes (1)

  • Choice of treatment

    Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)

Study Arms (1)

Patients with knee injuries

Patients referred to assessment at the Clinic of Sports Injuries

Other: Assessment at the Clinic of Sports Injuries

Interventions

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

Patients with knee injuries

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Middle aged patients with knee symptoms referred to the Clinic of Sports Injuries

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silkeborg Regional Hospital

Silkeborg, 8600, Denmark

Location

MeSH Terms

Conditions

Knee InjuriesWounds and Injuries

Condition Hierarchy (Ancestors)

Leg Injuries

Study Officials

  • Merete Nørgaard Madsen, PT

    University of Aarhus

    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 20, 2016

First Posted

February 3, 2016

Study Start

January 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 12, 2017

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations