Clinical trial NCT02974205: Rehabilitation of Patient With Acute Isolated PCL Rupture
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PCL
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2016-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: PCL stress-radiograph
timeFrame: 12 month
Secondary outcomes:
measure: KOOS (Knee Injury and Osteoarthritis Outcome score)
timeFrame: 12 month
measure: IKDC-2000 (Subjective Knee Evaluation Form)
timeFrame: 12 month
measure: One leg hop (in meters)
timeFrame: 12 month
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lars Engebretsen, Dr. Med
role: PRINCIPAL_INVESTIGATOR
References: