Rehabilitation of Patient With Acute Isolated PCL Rupture

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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PCL

Intervention / Treatment
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* Procedure: Jack brace
* Device: Rehabilitation
* Device: össur brace


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation with orthosis (Jack brace)<br> | Procedure: Jack brace<br>* Rehabilitation after acute isolated PCL rupture with orthosis<br>|
| Active Comparator: Rehabilitation without orthosis<br> | Device: Rehabilitation<br>* Rehabilitation after acute isolated PCL rupture without orthosis<br>|
| Active Comparator: Rehabilitation with orthosis (össur brace)<br> | Device: össur brace<br>* Rehabilitation after acute isolated PCL rupture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCL stress-radiograph |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS (Knee Injury and Osteoarthritis Outcome score) |  | 12 month | 
| IKDC-2000 (Subjective Knee Evaluation Form) |  | 12 month | 
| One leg hop (in meters) |  | 12 month |