Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01279759
• Other study ID #: 01339
• Status: Recruiting
• Phase: N/A
• First received: November 8, 2010
• Last updated: January 17, 2013
• Start date: October 2010
• Est. completion date: February 2015

Study information

• Verified date: January 2013
• Source: Haraldsplass Deaconess Hospital
• Contact: Willemijn Vervaat, MSc
• Phone: 004755978618
• Email: wive[@]haraldsplass.no
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Directorate of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess hospital	Bergen

Sponsors (3)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital	Norwegian Fund for Postgraduate Training in Physiotherapy, University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (24)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1136/bjsm.2008.057059. Epub 2009 Feb 17. — View Citation

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. doi: 10.1111/j.1600-0838.2008.00852.x. Epub 2008 Aug 5. — View Citation

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. — View Citation

Helbostad JL, Vereijken B, Hesseberg K, Sletvold O. Altered vision destabilizes gait in older persons. Gait Posture. 2009 Aug;30(2):233-8. doi: 10.1016/j.gaitpost.2009.05.004. Epub 2009 May 31. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1016/j.arthro.2009.02.014. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rice DA, McNair PJ. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. Semin Arthritis Rheum. 2010 Dec;40(3):250-66. doi: 10.1016/j.semarthrit.2009.10.001. Epub 2009 Dec 2. Review. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymmetry in step time between the affected and unaffected leg during down stairs walking.	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.	6 months postoperatively	No
Primary	Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX).		6 months postoperatively	No
Primary	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).		6 months postoperatively	No
Primary	Self reported function.	International Knee Documentation Committee 2000 subjective knee evaluation form.	6 months post operatively	No
Secondary	Pain scores on a visual analog scale		1 day preoperatively	No
Secondary	Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).		1 day preoperatively	No
Secondary	The circumference around the center of the patella will be measured to assess for swelling around the knee joint.		1 day preoperatively	No
Secondary	Passive range of movement compared to the healthy knee, measured with a goniometer.		1 day preoperatively	No
Secondary	Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX)		1 day preoperatively	No
Secondary	Asymmetry in step time between the affected and unaffected leg during down stairs walking.	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.	1 day preoperatively	No
Secondary	Self reported function	International Knee Documentation Committee 2000 subjective knee evaluation form	1 day preoperatively	No
Secondary	Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.		1 day preoperatively	No
Secondary	Passive range of movement compared to the healthy knee, measured with a goniometer.		at discharge	No
Secondary	Pain scores on a visual analog scale.		at discharge	No
Secondary	Difficulties with walking downstairs on a visual analog scale.		1 day preoperative	No
Secondary	Pain scores on a visual analog scale.		6 weeks post operatively	No
Secondary	Difficulties with walking down stairs on a visual analog scale.		6 weeks postoperatively	No
Secondary	Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).		6 weeks postoperatively	No
Secondary	The circumference around the center of the patella will be measured to assess for swelling around the knee joint.		6 weeks postoperatively	No
Secondary	Passive range of movement compared to the healthy knee will be measured with a goniometer.		6 weeks postoperatively	No
Secondary	Asymmetry in step time between the affected and unaffected leg during down stairs walking.	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.	6 weeks postoperatively	No
Secondary	Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.		6 weeks postoperatively	No
Secondary	Knee joint laxity measured with knee laxity testing device (KT 1000).		6 weeks postoperatively	No
Secondary	Asymmetry in step time between the affected and unaffected leg during down stairs walking.	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.	3 months postoperatively	No
Secondary	Pain scores on a visual analog scale.		3 months postoperatively	No
Secondary	Difficulties with walking down stairs on a visual analog scale.		3 months postoperatively	No
Secondary	Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).		3 months postoperatively	No
Secondary	The circumference around the center of the patella will be measured to assess for swelling around the knee joint.		3 months postoperatively	No
Secondary	Passive range of movement compared to the healthy knee, measured with a goniometer.		3 months postoperatively	No
Secondary	Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.		3 months postoperatively	No
Secondary	Knee joint laxity measured with a knee laxity testing device (KT 1000).		3 months postoperatively	No