ACL InjuryNCT03608189
Multimodal Assessment of Knee Conditions in Rehabilitation
An observational study of ACL Injury, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- ACL Injury
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2018to 31 Dec 2018
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patient participating in rehabilitation due to ACL injuries and potential other knee disorders.
Who may be able to join
- ACL injury
- Ages 18-40
- Female
Who cannot join
- BMI under 18
- BMI over 40
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Oulu
Oulu, North Ostrobothnia, 90014
Jérôme Thevenot, Ph.D., +358 294 48 6004, jerome.thevenot@oulu.fi
About this study
The purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.
- Conditions
- ACL Injury
- Keywords
- Osteoarthritis, ACL injury, Knee trauma, Meniscus tear
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACL injury subjects | Subjects with anterior cruciate ligament injuries. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective evaluation method for knee disorder recovery
ACL injury recovery (confirmed by using MRI)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simo Saarakkala, Ph.D., Principal investigator, University of OuluOsmo Tervonen, Ph.D., M.D., Study director, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608189
- Sponsor's protocol ID
- 24302214-1
- Other IDs
- 24302214
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Knee Conditions in Rehabilitation
- ClinicalTrials.gov ID
- NCT03608189
- Acronym / sponsor ID
- 24302214-1
- Conditions
- ACL Injury
- Keywords
- Osteoarthritis, ACL injury, Knee trauma, Meniscus tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 Jul 2018 (actual)
- 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 purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL injury subjects | – | –Subjects with anterior cruciate ligament injuries. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient participating in rehabilitation due to ACL injuries and potential other knee disorders.
Key inclusion criteria (3 listed)
- ACL injury
- Ages 18-40
- Female
Key exclusion criteria (3 listed)
- BMI under 18
- BMI over 40
- Contraindications to MRI
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
Objective evaluation method for knee disorder recovery
Time frame: Six months
ACL injury recovery (confirmed by using MRI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
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.
Simo Saarakkala, Ph.D. principal investigator
University of Oulu
Osmo Tervonen, Ph.D., M.D. study director
Oulu University Hospital
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 ACL Injury, run by University of Oulu at 1 site in Finland.
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 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: status not confirmed, as of the sponsor's last update on 31 Jul 2018. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Thevenot, PhD (+358 294 48 6004, jerome.thevenot@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective evaluation method for knee disorder recovery (time frame: Six months). 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 31 Jul 2018.