Rehabilitation of Patient With Acute Isolated PCL Rupture

PCL Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974205
• Other study ID #: 579239
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: November 22, 2016
• Start date: January 2016
• Est. completion date: September 2025

Study information

• Verified date: November 2016
• Source: Oslo University Hospital
• Contact: Ingrid Trøan, PT
• Phone: +479888593
• Email: ingrid.troan[@]ous-hf.no
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• PCL

Intervention

Procedure:
• Jack brace
Rehabilitation after acute isolated PCL rupture with orthosis

Device:
• Rehabilitation
Rehabilitation after acute isolated PCL rupture without orthosis
• össur brace
Rehabilitation after acute isolated PCL rupture

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog
Norway	Oslo University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCL stress-radiograph		12 month	Yes
Secondary	KOOS (Knee Injury and Osteoarthritis Outcome score)		12 month	Yes
Secondary	IKDC-2000 (Subjective Knee Evaluation Form)		12 month	Yes
Secondary	One leg hop (in meters)		12 month	Yes