PCLNCT02974205
Rehabilitation of Patient With Acute Isolated PCL Rupture
A study testing Jack brace, Rehabilitation and össur brace in people with PCL, run by Oslo University Hospital at 2 sites in Norway.
Trial summary
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and… Read more about this study
- Who is it for?
- Ages 16 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PCL
- What is being tested?
- Jack brace, Rehabilitation and össur brace
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2016to Sep 2025
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Acute isolated PCL injury : 0- 3 weeks ( maximum 21 days) from the initial injury
- Isolated PCL rupture (grade I, II and III)
- Patient age should be between 16-60 years ( with closed epiphyseal plate )
- Understood and accepted written consent
Who cannot join
- Injury to the ACL or other ligaments in the knee
- Extensive injury to the cartilage or meniscus , requiring repairs
- Unfit to understand or to sign consent
- History of alcohol or drug abuse in the past three years
- Current serious illness or injury that makes rehabilitation difficult.
Trial locations and contacts
2 sites in 1 country.
Karin Bredland, PT, MSc contact
Norway2 sites, 2 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, 1478
Hilde Stømner, PT, Hilde.Christina.Stomner@ahus.no
- Recruiting
Oslo University Hospital
Oslo, 0182
Ingrid Trøan, PT, 22117213, uxtrai@ous-hf.no
Karin Bredland, PT, MSc, 22117213, uxkbar@ous-hf.no
About this study
Official title: Kneelaxity and Self-reported Knee Function After Rehabilitation With the Use of Dynamic Kneeorthosis for Patients With Acute Isolated Posterior Cruciate Ligament Injury: A Randomized Controlled Trial
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000)
Read the detailed description
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee function. Participants considered included in the study if he or she agrees to participate in the study by signing the informed consent. Inclusion criteria will be whether the patient has an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and meniscus of the knee. Randomization to groups is done continuously.
- Conditions
- PCL
- Being tested
- Jack brace, Rehabilitation, össur brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jack braceProcedure or surgery
Rehabilitation after acute isolated PCL rupture with orthosis
RehabilitationDevice
Rehabilitation after acute isolated PCL rupture without orthosis
össur braceDevice
Rehabilitation after acute isolated PCL rupture
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with orthosis (Jack brace) | Active comparator | Not described Receives: Procedure: Jack brace |
| Rehabilitation without orthosis | Active comparator | Not described Receives: Device: Rehabilitation |
| Rehabilitation with orthosis (össur brace) | Active comparator | Not described Receives: Device: össur brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCL stress-radiograph
Measured: 12 month
Secondary outcomes (3)
KOOS (Knee Injury and Osteoarthritis Outcome score)
Measured: 12 month
IKDC-2000 (Subjective Knee Evaluation Form)
Measured: 12 month
One leg hop (in meters)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCLStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus
- Responsible party
- Principal investigator, Ingrid Trøan, Oslo University Hospital
- Investigators
- Lars Engebretsen, Dr. Med, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974205
- Sponsor's protocol ID
- 579239
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kneelaxity and Self-reported Knee Function After Rehabilitation With the Use of Dynamic Kneeorthosis for Patients With Acute Isolated Posterior Cruciate Ligament Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02974205
- Acronym / sponsor ID
- 579239
- Conditions
- PCL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus
- Study start
- Jan 2016
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Nov 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 posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000)
Detailed description
The posterior cruciate ligament injuries (PCL) is rare and rehabilitation methods are varying. The purpose of the study is to explore if one rehabilitation option is preferable to one other for patients with acute PCL injury, by examining whether there will be differences in laxity in the knee joints and patient-reported knee function by three different rehabilitation protocols. A randomized controlled trial with 75 patients enrolled will be followed up 3 and 12 months after injury. The groups will be compared using kneelaxity (stress - X) and subjective knee function (KOOS, IKDC-2000) to indicate whether one rehabilitation alternative is preferable in terms of less knee joint laxity and improve knee function. Participants considered included in the study if he or she agrees to participate in the study by signing the informed consent. Inclusion criteria will be whether the patient has an acute isolated PCL injury. Exclusion is additional injuries of ligaments, cartilage and meniscus of the knee. Randomization to groups is done continuously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with orthosis (Jack brace) | Active comparator | Procedure: Jack brace |
| Rehabilitation without orthosis | Active comparator | Device: Rehabilitation |
| Rehabilitation with orthosis (össur brace) | Active comparator | Device: össur brace |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Acute isolated PCL injury : 0- 3 weeks ( maximum 21 days) from the initial injury
- Isolated PCL rupture (grade I, II and III)
- Patient age should be between 16-60 years ( with closed epiphyseal plate )
- Understood and accepted written consent
Key exclusion criteria (5 listed)
- Injury to the ACL or other ligaments in the knee
- Extensive injury to the cartilage or meniscus , requiring repairs
- Unfit to understand or to sign consent
- History of alcohol or drug abuse in the past three years
- Current serious illness or injury that makes rehabilitation difficult.
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 |
|---|---|---|
| Jack braceRehabilitation after acute isolated PCL rupture with orthosis | Procedure or surgery | Rehabilitation with orthosis (Jack brace) |
| RehabilitationRehabilitation after acute isolated PCL rupture without orthosis | Device | Rehabilitation without orthosis |
| össur braceRehabilitation after acute isolated PCL rupture | Device | Rehabilitation with orthosis (össur brace) |
Primary outcome
PCL stress-radiograph
Time frame: 12 month
3 secondary outcomes
KOOS (Knee Injury and Osteoarthritis Outcome score)
Time frame: 12 month
IKDC-2000 (Subjective Knee Evaluation Form)
Time frame: 12 month
One leg hop (in meters)
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Karin Bredland, PT, MSc contact
Lars Engebretsen, Dr. Med principal investigator
Oslo University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jack brace, Rehabilitation and össur brace in people with PCL, run by Oslo University Hospital at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Trøan, PT (+479888593, ingrid.troan@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCL stress-radiograph (time frame: 12 month). 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 28 Nov 2016.