Rehabilitation of Patient With Acute Isolated PCL Rupture

Not Applicable

Recruiting

• Conditions: PCL
• Interventions: Procedure: Jack brace; Device: Rehabilitation; Device: össur brace

• Registration Number: NCT02974205
• Lead Sponsor: Oslo University Hospital

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.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-11
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-22
• Last Update Submitted: 2016-11-22
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rehabilitation with orthosis (Jack brace)	Jack brace	-
Rehabilitation without orthosis	Rehabilitation	-
Rehabilitation with orthosis (össur brace)	össur brace	-

Primary Outcome Measures

Name	Time	Method
PCL stress-radiograph	12 month

Secondary Outcome Measures

Name	Time	Method
KOOS (Knee Injury and Osteoarthritis Outcome score)	12 month
IKDC-2000 (Subjective Knee Evaluation Form)	12 month
One leg hop (in meters)	12 month

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway