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Rehabilitation of Patient With Acute Isolated PCL Rupture

NCT ID: NCT02974205

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2025-09-30

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.

Conditions

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PCL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rehabilitation with orthosis (Jack brace)

Group Type ACTIVE_COMPARATOR

Jack brace

Intervention Type PROCEDURE

Rehabilitation after acute isolated PCL rupture with orthosis

Rehabilitation without orthosis

Group Type ACTIVE_COMPARATOR

Rehabilitation

Intervention Type DEVICE

Rehabilitation after acute isolated PCL rupture without orthosis

Rehabilitation with orthosis (össur brace)

Group Type ACTIVE_COMPARATOR

össur brace

Intervention Type DEVICE

Rehabilitation after acute isolated PCL rupture

Interventions

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Jack brace

Rehabilitation after acute isolated PCL rupture with orthosis

Intervention Type PROCEDURE

Rehabilitation

Rehabilitation after acute isolated PCL rupture without orthosis

Intervention Type DEVICE

össur brace

Rehabilitation after acute isolated PCL rupture

Intervention Type DEVICE

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ingrid Trøan

PT, MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lars Engebretsen, Dr. Med

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Akershus University Hospital

Lørenskog, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Ingrid Trøan, PT

Role: CONTACT

Phone: +479888593

Email: [email protected]

Karin Bredland, PT, MSc

Role: CONTACT

Facility Contacts

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Hilde Stømner, PT

Role: primary

Ingrid Trøan, PT

Role: primary

Karin Bredland, PT, MSc

Role: backup

Other Identifiers

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579239

Identifier Type: -

Identifier Source: org_study_id