Knee InjuriesNCT02672046
Optimized Referral of Knee Patients at the Clinic of Sports Injuries
An observational study of Knee Injuries and Knee; Injury, Meniscus (Lateral) (Medial), run by Central Jutland Regional Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Knee Injuries, Knee; Injury, Meniscus (Lateral) (Medial)
- What is being tested?
- Assessment at the Clinic of Sports Injuries
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Middle aged patients with knee symptoms referred to the Clinic of Sports Injuries
Who may be able to join
- Patients above the age of 35 referred to the Clinic of Sports Injuries with knee symptoms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Danish Title: Optimeret Visitation af Midaldrende knæpatienter Med Symptomer Muligvis Relateret Til Meniskskade
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.
Read the detailed 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.
- Being tested
- Assessment at the Clinic of Sports Injuries
- Medical subject headings
- Knee Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment at the Clinic of Sports InjuriesOther
Assessment at the Clinic of Sports Injuries as well as a new algorithm (using patient-reported symptoms will be applied
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee injuries | Patients referred to assessment at the Clinic of Sports Injuries Receives: Other: Assessment at the Clinic of Sports Injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Relevant referral to assessment by physician" or "Relevant referral to assessment by physiotherapist"
Measured: Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)
Secondary outcomes (1)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Merete Nørgaard Madsen, PT, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672046
- Sponsor's protocol ID
- 6300002
- Status last verified
- Jan 2016
- First submitted
- 20 Jan 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Danish Title: Optimeret Visitation af Midaldrende knæpatienter Med Symptomer Muligvis Relateret Til Meniskskade
- ClinicalTrials.gov ID
- NCT02672046
- Acronym / sponsor ID
- 6300002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee injuries | – | Other: Assessment at the Clinic of Sports InjuriesPatients referred to assessment at the Clinic of Sports Injuries |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Middle aged patients with knee symptoms referred to the Clinic of Sports Injuries
Key inclusion criteria (1 listed)
- Patients above the age of 35 referred to the Clinic of Sports Injuries with knee symptoms
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment at the Clinic of Sports InjuriesAssessment at the Clinic of Sports Injuries as well as a new algorithm (using patient-reported symptoms will be applied | Other | Patients with knee injuries |
Primary outcome
"Relevant referral to assessment by physician" or "Relevant referral to assessment by physiotherapist"
Time frame: Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)
1 secondary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Individual participant dataSharing planned: No
Related trials for Knee Injuries
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Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
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Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Nørgaard Madsen, PT principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Injuries and Knee; Injury, Meniscus (Lateral) (Medial), run by Central Jutland Regional Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Relevant referral to assessment by physician" or "Relevant referral to assessment by physiotherapist" (time frame: Up to 4 weeks (at the initial visit at the Clinic of Sports Injuries)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.