Anterior Cruciate Ligament InjuryNCT02115451
Nonsurgical or Surgical Treatment of ACL Injuries
An observational study of Anterior Cruciate Ligament Injury, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- How many people
- 143 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Jun 2013
- 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 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Athletically active anterior cruciate ligament injured patients
Who may be able to join
- Anterior cruciate ligament rupture within 3 months of injury
- Preinjury participation in level I or II sports at least twice a week
Who cannot join
- Current or previous injury to the contralateral leg
- Another grade III ligament injury, fracture, full-thickness articular cartilage damage
Trial locations and contacts
1 site in 1 country.
Norway1 site
NAR- Department of Orthopaedics, Oslo University Hospital & Nimi
Oslo, Oslo, 0407
About this study
Official title: Dynamic Stability of the ACL Deficient Knee
The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury
Read the detailed description
This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.
- Conditions
- Anterior Cruciate Ligament Injury
- Medical subject headings
- Anterior Cruciate Ligament Injuries
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 |
|---|---|---|
| Surgical treatment | Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed | |
| Nonsurgical treatment | Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported knee function (IKDC 2000)
Measured: 2 years
Secondary outcomes (3)
Isokinetic knee extensor and flexor muscle strength
Measured: 2 years
Knee reinjury
Measured: 2 years
Participation in level I, II and III sports
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJan 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Sponsor
- Investigators
- May Arna Risberg, PT PhD, Principal investigator, Norwegian Research Center for Active Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115451
- Sponsor's protocol ID
- 685-06289
- Status last verified
- Apr 2014
- First submitted
- 14 Apr 2014
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Stability of the ACL Deficient Knee
- ClinicalTrials.gov ID
- NCT02115451
- Acronym / sponsor ID
- 685-06289
- Conditions
- Anterior Cruciate Ligament Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- Jan 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2014 (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 this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury
Detailed description
This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | – | –Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed |
| Nonsurgical treatment | – | –Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Athletically active anterior cruciate ligament injured patients
Key inclusion criteria (2 listed)
- Anterior cruciate ligament rupture within 3 months of injury
- Preinjury participation in level I or II sports at least twice a week
Key exclusion criteria (2 listed)
- Current or previous injury to the contralateral leg
- Another grade III ligament injury, fracture, full-thickness articular cartilage damage
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
Patient-reported knee function (IKDC 2000)
Time frame: 2 years
3 secondary outcomes
Isokinetic knee extensor and flexor muscle strength
Time frame: 2 years
Knee reinjury
Time frame: 2 years
Participation in level I, II and III sports
Time frame: 2 years
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 25 Apr 2014.
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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.
May Arna Risberg, PT PhD principal investigator
Norwegian Research Center for Active Rehabilitation
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 Anterior Cruciate Ligament Injury, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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 25 Apr 2014. 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 Norway. 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?
Patient-reported knee function (IKDC 2000) (time frame: 2 years). 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 25 Apr 2014.