Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anterior Cruciate Ligament Reconstruction

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX). |  | 6 months postoperatively | 
| 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 | 
| Self reported function. | International Knee Documentation Committee 2000 subjective knee evaluation form. | 6 months post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores on a visual analog scale |  | 1 day preoperatively | 
| Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). |  | 1 day preoperatively | 
| The circumference around the center of the patella will be measured to assess for swelling around the knee joint. |  | 1 day preoperatively | 
| Passive range of movement compared to the healthy knee, measured with a goniometer. |  | 1 day preoperatively | 
| Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX) |  | 1 day preoperatively | 
| 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 | 
| Self reported function | International Knee Documentation Committee 2000 subjective knee evaluation form | 1 day preoperatively | 
| Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. |  | 1 day preoperatively | 
| Passive range of movement compared to the healthy knee, measured with a goniometer. |  | at discharge | 
| Pain scores on a visual analog scale. |  | at discharge | 
| Difficulties with walking downstairs on a visual analog scale. |  | 1 day preoperative | 
| Pain scores on a visual analog scale. |  | 6 weeks post operatively | 
| Difficulties with walking down stairs on a visual analog scale. |  | 6 weeks postoperatively | 
| Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). |  | 6 weeks postoperatively | 
| The circumference around the center of the patella will be measured to assess for swelling around the knee joint. |  | 6 weeks postoperatively | 
| Passive range of movement compared to the healthy knee will be measured with a goniometer. |  | 6 weeks postoperatively | 
| 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 | 
| Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. |  | 6 weeks postoperatively | 
| Knee joint laxity measured with knee laxity testing device (KT 1000). |  | 6 weeks postoperatively | 
| 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 | 
| Pain scores on a visual analog scale. |  | 3 months postoperatively | 
| Difficulties with walking down stairs on a visual analog scale. |  | 3 months postoperatively | 
| Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010). |  | 3 months postoperatively | 
| The circumference around the center of the patella will be measured to assess for swelling around the knee joint. |  | 3 months postoperatively | 
| Passive range of movement compared to the healthy knee, measured with a goniometer. |  | 3 months postoperatively | 
| Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line. |  | 3 months postoperatively | 
| Knee joint laxity measured with a knee laxity testing device (KT 1000). |  | 3 months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Reconstruction Predictive Factors, Function Downstairs walking Step time Symmetry