Knee InjuryNCT01382173
Monitoring Of Helsingborg Acute Knee Injuries (MOHAK)
An observational study of Knee Injury and Knee Osteoarthritis, run by Lund University at 1 site in Sweden.
Trial summary
Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Knee Injury, Knee Osteoarthritis
- How many people
- 192 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Sep 2020
- 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 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: We will recruit approximately 150 patients annually over 3-4 years with the goal of including at least: * 200 knees with isolated or combined ACL injuries * 50 isolated meniscus tears * 50 primary patellar dislocations * 50 contusions without ligamentous, cartilage or meniscus injury. Patients will be recruited using two different strategies: 1. Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital 2. Those referred to the orthopedic outpatient health care unit of Helsingborg hospital due to an acute knee injury by their primary health care unit will be scheduled for a clinical visit for baseline assessment (visit 1) within four weeks from their injury. To facilitate recruitment, primary care units in the local area of Helsingborg will be offered an opportunity to refer all patients with rotational knee trauma and effusion directly to the orthopedic outpatient care unit.
Who may be able to join
- Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
- A history of knee injury not more than 4 weeks prior to inclusion
- Agreement and informed consent to participate in the study
Who cannot join
- Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
- Pregnancy
- A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
- General disease that effects physical function or systemic medication/abuse of steroids
- Any other condition or treatment interfering with the completion or assessment of the trial.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Helsingborg hospital
Helsingborg, S-251 85
About this study
Official title: Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.
Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.
- Conditions
- Knee Injury, Knee Osteoarthritis
- Keywords
- Knee injury, Osteoarthritis, Anterior Cruciate Ligament injury, Patellar dislocation
- Medical subject headings
- Knee Injuries, Osteoarthritis, Knee, Osteoarthritis, Anterior Cruciate Ligament Injuries, Patellar Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: 5 yrs
Secondary outcomes (1)
Radiographic osteoarthritis
Measured: 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMar 2012
- Primary completionJan 2017
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuryStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Crafoord Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382173
- Sponsor's protocol ID
- MOHAK-11
- Status last verified
- Sep 2020
- First submitted
- 23 Jun 2011
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Of Helsingborg Acute Knee Injuries (MOHAK) to Understand Osteoarthritis Development After Injury.
- ClinicalTrials.gov ID
- NCT01382173
- Acronym / sponsor ID
- MOHAK-11
- Conditions
- Knee Injury, Knee Osteoarthritis
- Keywords
- Knee injury, Osteoarthritis, Anterior Cruciate Ligament injury, Patellar dislocation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Crafoord Foundation
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 27 Jun 2011 (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.
Using magnetic resonance imaging (MRI), laboratory analyses and patient reported outcomes, the overall aim of this study is to investigate structural injuries and biochemical alterations in the acutely injured knee and to relate these findings to clinical outcomes at various time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- We will recruit approximately 150 patients annually over 3-4 years with the goal of including at least: * 200 knees with isolated or combined ACL injuries * 50 isolated meniscus tears * 50 primary patellar dislocations * 50 contusions without ligamentous, cartilage or meniscus injury. Patients will be recruited using two different strategies: 1. Those seeking medical care at the orthopedic emergency room (ER) at Helsingborg hospital 2. Those referred to the orthopedic outpatient health care unit of Helsingborg hospital due to an acute knee injury by their primary health care unit will be scheduled for a clinical visit for baseline assessment (visit 1) within four weeks from their injury. To facilitate recruitment, primary care units in the local area of Helsingborg will be offered an opportunity to refer all patients with rotational knee trauma and effusion directly to the orthopedic outpatient care unit.
Key inclusion criteria (3 listed)
- Age 12-40 years at inclusion (inclusion of patients younger than 18 will require parental approval)
- A history of knee injury not more than 4 weeks prior to inclusion
- Agreement and informed consent to participate in the study
Key exclusion criteria (5 listed)
- Any MRI contra-indications (such as extreme obesity, metal implants, claustrophobia etc.)
- Pregnancy
- A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
- General disease that effects physical function or systemic medication/abuse of steroids
- Any other condition or treatment interfering with the completion or assessment of the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 5 yrs
1 secondary outcome
Radiographic osteoarthritis
Time frame: 5 yrs
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Injury and Knee Osteoarthritis, run by Lund University at 1 site in Sweden.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Sep 2020. 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 Sweden. 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 was stopped early. Results are not available in the source record.
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?
Knee injury and Osteoarthritis Outcome Score (KOOS) (time frame: 5 yrs). 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 10 Sep 2020.