Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Haraldsplass Deaconess Hospital
Sponsor:
Collaborators:
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier:
NCT01279759
First received: November 8, 2010
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.

Condition
Anterior Cruciate Ligament Reconstruction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Haraldsplass Deaconess Hospital:

Primary Outcome Measures:
  • Asymmetry in step time between the affected and unaffected leg during down stairs walking. [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    A triaxial kinematic sensor (XSens Mtx) positioned at the level of the lower trunk will be used to identify foot strike and separate left and right steps.

  • Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX). [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
  • Single leg hop test for distance, a 6-m timed hop test, a triple hop test for distance, a crossover hop test for distance (Noyes et al, 1991). [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
  • Self reported function. [ Time Frame: 6 months post operatively ] [ Designated as safety issue: No ]
    International Knee Documentation Committee 2000 subjective knee evaluation form.


Secondary Outcome Measures:
  • Pain scores on a visual analog scale [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • The circumference around the center of the patella will be measured to assess for swelling around the knee joint. [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • Passive range of movement compared to the healthy knee, measured with a goniometer. [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX) [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • Asymmetry in step time between the affected and unaffected leg during down stairs walking. [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
    A triaxial kinematic sensor (XSens Mtx) positioned at the level of the lower trunk will be used to identify foot strike and separate left and right steps.

  • Self reported function [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
    International Knee Documentation Committee 2000 subjective knee evaluation form

  • Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. [ Time Frame: 1 day preoperatively ] [ Designated as safety issue: No ]
  • Passive range of movement compared to the healthy knee, measured with a goniometer. [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • Pain scores on a visual analog scale. [ Time Frame: at discharge ] [ Designated as safety issue: No ]
  • Difficulties with walking downstairs on a visual analog scale. [ Time Frame: 1 day preoperative ] [ Designated as safety issue: No ]
  • Pain scores on a visual analog scale. [ Time Frame: 6 weeks post operatively ] [ Designated as safety issue: No ]
  • Difficulties with walking down stairs on a visual analog scale. [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • The circumference around the center of the patella will be measured to assess for swelling around the knee joint. [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • Passive range of movement compared to the healthy knee will be measured with a goniometer. [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • Asymmetry in step time between the affected and unaffected leg during down stairs walking. [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
    A triaxial kinematic sensor (XSens Mtx) positioned at the level of the lower trunk will be used to identify foot strike and separate left and right steps.

  • Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • Knee joint laxity measured with knee laxity testing device (KT 1000). [ Time Frame: 6 weeks postoperatively ] [ Designated as safety issue: No ]
  • Asymmetry in step time between the affected and unaffected leg during down stairs walking. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
    A triaxial kinematic sensor (XSens Mtx) positioned at the level of the lower trunk will be used to identify foot strike and separate left and right steps.

  • Pain scores on a visual analog scale. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Difficulties with walking down stairs on a visual analog scale. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • The circumference around the center of the patella will be measured to assess for swelling around the knee joint. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Passive range of movement compared to the healthy knee, measured with a goniometer. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • Knee joint laxity measured with a knee laxity testing device (KT 1000). [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: October 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients planned for reconstruction of the anterioir crucuate ligament with hamstrings graft.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279759

Contacts
Contact: Willemijn Vervaat, MSc 004755978618 wive@haraldsplass.no

Locations
Norway
Haraldsplass Deaconess hospital Recruiting
Bergen, Norway, 5096
Contact: Solveig Ullaland    0047-55978541      
Principal Investigator: Willemijn Vervaat, MSc         
Sub-Investigator: Rolf Moe-Nilssen, PhD         
Sub-Investigator: Bård Bogen, MSc         
Sub-Investigator: Thomas Harlem, surgeon         
Sub-Investigator: Rune Børnes, physiot.         
Sub-Investigator: Gro Hilde Vik, physiot         
Sub-Investigator: Anne Gro Faleide, physiot         
Sub-Investigator: Grete Utkilen, physiot.         
Sub-Investigator: Grethe Gjendemsjø, physiot         
Sub-Investigator: Synnøve Misje, Physiot.         
Sponsors and Collaborators
Haraldsplass Deaconess Hospital
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Investigators
Principal Investigator: Willemijn Vervaat, MSc Haraldsplass Deaconess Hospital
  More Information

Publications:

Responsible Party: Haraldsplass Deaconess Hospital
ClinicalTrials.gov Identifier: NCT01279759     History of Changes
Other Study ID Numbers: 01339
Study First Received: November 8, 2010
Last Updated: January 17, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by Haraldsplass Deaconess Hospital:
Anterior Cruciate Ligament Reconstruction Predictive Factors
Function Downstairs walking Step time Symmetry

ClinicalTrials.gov processed this record on July 22, 2014