Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction - Full Text View

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:

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

MedlinePlus related topics: Edema Knee Injuries and Disorders Plastic and Cosmetic Surgery

U.S. FDA Resources

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

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:

Adlerton AK, Moritz U, Moe-Nilssen R. Forceplate and accelerometer measures for evaluating the effect of muscle fatigue on postural control during one-legged stance. Physiother Res Int. 2003;8(4):187-99.

Arvidsson I, Arvidsson H, Eriksson E, Jansson E. Prevention of quadriceps wasting after immobilization: an evaluation of the effect of electrical stimulation. Orthopedics. 1986 Nov;9(11):1519-28.

Bjordal JM, Arn?y F, Hannestad B, Strand T. Epidemiology of anterior cruciate ligament injuries in soccer. Am J Sports Med. 1997 May-Jun;25(3):341-5.

Daniel DM, Stone ML, Dobson BE, Fithian DC, Rossman DJ, Kaufman KR. Fate of the ACL-injured patient. A prospective outcome study. Am J Sports Med. 1994 Sep-Oct;22(5):632-44.

de Jong SN, van Caspel DR, van Haeff MJ, Saris DB. Functional assessment and muscle strength before and after reconstruction of chronic anterior cruciate ligament lesions. Arthroscopy. 2007 Jan;23(1):21-8, 28.e1-3.

Drechsler WI, Cramp MC, Scott OM. Changes in muscle strength and EMG median frequency after anterior cruciate ligament reconstruction. Eur J Appl Physiol. 2006 Dec;98(6):613-23. Epub 2006 Oct 12.

Eitzen I, Holm I, Risberg MA. Preoperative quadriceps strength is a significant predictor of knee function two years after anterior cruciate ligament reconstruction. Br J Sports Med. 2009 May;43(5):371-6. Epub 2009 Feb 17.

Helbostad JL, Vereijken B, Hesseberg K, Sletvold O. Altered vision destabilizes gait in older persons. Gait Posture. 2009 Aug;30(2):233-8. Epub 2009 May 31.

Hodt-Billington C, Helbostad JL, Moe-Nilssen R. Should trunk movement or footfall parameters quantify gait asymmetry in chronic stroke patients? Gait Posture. 2008 May;27(4):552-8. Epub 2007 Sep 25.

Holder-Powell HM, Di Matteo G, Rutherford OM. Do knee injuries have long-term consequences for isometric and dynamic muscle strength? Eur J Appl Physiol. 2001 Aug;85(3-4):310-6.

Johansson H, Sjölander P, Sojka P. Receptors in the knee joint ligaments and their role in the biomechanics of the joint. Crit Rev Biomed Eng. 1991;18(5):341-68. Review.

Kowalchuk DA, Harner CD, Fu FH, Irrgang JJ. Prediction of patient-reported outcome after single-bundle anterior cruciate ligament reconstruction. Arthroscopy. 2009 May;25(5):457-63.

McHugh MP, Tyler TF, Browne MG, Gleim GW, Nicholas SJ. Electromyographic predictors of residual quadriceps muscle weakness after anterior cruciate ligament reconstruction. Am J Sports Med. 2002 May-Jun;30(3):334-9.

Moe-Nilssen R. A new method for evaluating motor control in gait under real-life environmental conditions. Part 2: Gait analysis. Clin Biomech (Bristol, Avon). 1998 Jun;13(4-5):328-335.

Moe-Nilssen R. A new method for evaluating motor control in gait under real-life environmental conditions. Part 1: The instrument. Clin Biomech (Bristol, Avon). 1998 Jun;13(4-5):320-327.

Moe-Nilssen R, Helbostad JL, Akra T, Birdedal L, Nygaard HA. Modulation of gait during visual adaptation to dark. J Mot Behav. 2006 Mar;38(2):118-25.

Myklebust G, Holm I, Maehlum S, Engebretsen L, Bahr R. Clinical, functional, and radiologic outcome in team handball players 6 to 11 years after anterior cruciate ligament injury: a follow-up study. Am J Sports Med. 2003 Nov-Dec;31(6):981-9.

Noyes FR, Barber SD, Mangine RE. Abnormal lower limb symmetry determined by function hop tests after anterior cruciate ligament rupture. Am J Sports Med. 1991 Sep-Oct;19(5):513-8.

Rice DA, McNair PJ. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. Semin Arthritis Rheum. 2010 Dec;40(3):250-66. Epub 2009 Dec 2.

Sorsdahl AB, Moe-Nilssen R, Strand LI. Test-retest reliability of spatial and temporal gait parameters in children with cerebral palsy as measured by an electronic walkway. Gait Posture. 2008 Jan;27(1):43-50. Epub 2007 Feb 14.

Young A. Current issues in arthrogenous inhibition. Ann Rheum Dis. 1993 Nov;52(11):829-34. Review.

Heijne A, Ang BO, Werner S. Predictive factors for 12-month outcome after anterior cruciate ligament reconstruction. Scand J Med Sci Sports. 2009 Dec;19(6):842-9. Epub 2008 Aug 5.

Helbostad JL, Leirfall S, Moe-Nilssen R, Sletvold O. Physical fatigue affects gait characteristics in older persons. J Gerontol A Biol Sci Med Sci. 2007 Sep;62(9):1010-5.

Williams GN, Barrance PJ, Snyder-Mackler L, Buchanan TS. Altered quadriceps control in people with anterior cruciate ligament deficiency. Med Sci Sports Exerc. 2004 Jul;36(7):1089-97.

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 May 21, 2013