Rehabilitation of Patient With Acute Isolated PCL Rupture

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)

Study Overview

• Status: Recruiting
• Conditions: PCL
• Intervention / Treatment: Procedure: Jack brace; Device: Rehabilitation; Device: össur brace

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ingrid Trøan, PT; Phone Number: +479888593; Email: ingrid.troan@ous-hf.no
• Study Contact Backup: Name: Karin Bredland, PT, MSc

Study Locations

• Norway
  • Lørenskog, Norway, 1478
    • Recruiting
    • Akershus University Hospital
    • Contact: Hilde Stømner, PT; Email: Hilde.Christina.Stomner@ahus.no
  • Oslo, Norway, 0182
    • Recruiting
    • Oslo University Hospital
    • Contact: Ingrid Trøan, PT; Phone Number: 22117213; Email: uxtrai@ous-hf.no
    • Contact: Karin Bredland, PT, MSc; Phone Number: 22117213; Email: uxkbar@ous-hf.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rehabilitation with orthosis (Jack brace)	Procedure: Jack brace; Rehabilitation after acute isolated PCL rupture with orthosis
Active Comparator: Rehabilitation without orthosis	Device: Rehabilitation; Rehabilitation after acute isolated PCL rupture without orthosis
Active Comparator: Rehabilitation with orthosis (össur brace)	Device: össur brace; Rehabilitation after acute isolated PCL rupture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PCL stress-radiograph	12 month

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital, Akershus
• Investigators: Principal Investigator: Lars Engebretsen, Dr. Med, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): September 1, 2025

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 579239

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No