Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction

NCT ID: NCT01279759

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2015-02-28

Brief Summary

Background:

An estimated 4000 Anterior Cruciate Ligament Injuries (ACL) occur annually in Norway (Granan et al., 2004). 1630 primary ACL reconstructions were performed in Norway in 2008 (Norwegian Arthroplasty Register, 2009). Approximately 120 of these ACL reconstructions were performed at Haraldsplass Deaconess Hospital.

Physical therapists at our hospital are responsible for postoperative outpatient controls of patients with a reconstructed anterior cruciate ligament. A clinical observation is that stair walking (especially downstairs) may be problematic up to 6 months after ACL reconstruction. One reason may be that the quadriceps muscle is unable to control the knee when the subject is walking downstairs, and that the knee is perceived to be unstable. Other contributing factors may be pain and swelling.

It is of interest to know which pre and post operative factors can predict measured and patient reported function 6 months after ACL reconstruction. Previous research shows that predictive factors for clinical outcome after ACL reconstruction are anterior knee pain (Heijne et al., 2009), preoperative electromyography, early postoperative strength (McHugh et al., 2002), preoperative quadriceps muscle strength deficits, meniscus injury and pain (Eitzen et al., 2009), obesity, smoking and serious chondrosis (Kowalchuk et al., 2009).

Purpose:

1. To analyse which pre and post operative factors can predict measured and patient reported function 6 months after Anterior Cruciate Ligament reconstruction.

2. To investigate if there is an asymmetry in step time between the affected and unaffected leg during down stairs walking, and if degree of asymmetry decreases during a 6 months period post operatively. Further we want to compare step time asymmetry with other established outcome measures to investigate sensitivity to change over the observation period and also compare the patient group in this study with a control group of healthy subjects to see if asymmetry in the patient group after 6 months is still higher than in healthy subjects.

Detailed Description

Methods:

The investigators wish to recruit 35 people scheduled for anterior cruciate ligament (ACL) reconstruction with hamstrings tendon graft.

Patients will be asked to write a training diary.

Data will be collected 1 day preoperatively, 2 days, 6 weeks, 3 months and 6 months post operatively.

Ethics:

All participants will have to give informed consent before inclusion. All information obtained through the surveys will be treated confidentially. Participation is completely voluntary.

References:

GRANAN, L., ENGEBRETSEN, L. & BAHR, R. (2004) Kirurgi ved fremre korsbåndskader i Norge - sett fra et idrettsmedisinsk perspektiv. Tidsskr Nor Lægeforen, 124, 928-930.

NASJONALT REGISTER FOR LEDDPROTESER (2009) Nasjonalt korsbåndregister. Ortopedisk klinikk Haukeland Universitets Sykehus.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients planned for reconstruction of the anterior cruciate ligament with hamstrings graft at Haraldsplass Deaconess hospital.

Exclusion Criteria

• Patients with multiligament tears, meniscus suture, other problems that can influence strength testing, functional testing and gait symmetry.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Norwegian Fund for Postgraduate Training in Physiotherapy

OTHER

Sponsor Role: collaborator

Haraldsplass Deaconess Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willemijn Vervaat, MSc

Role: PRINCIPAL_INVESTIGATOR

Haraldsplass Deaconess Hospital

Locations

Haraldsplass Deaconess hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Willemijn Vervaat, MSc

Role: CONTACT

wive@haraldsplass.no

004755978618

Facility Contacts

Solveig Ullaland

Role: primary

0047-55978541

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Other Identifiers

01339

Identifier Type: -

Identifier Source: org_study_id