Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction

NCT01279759 | Unknown

• 1 other identifier: 01339
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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. 1.To analyse which pre and post operative factors can predict measured and patient reported function 6 months after Anterior Cruciate Ligament reconstruction.
2. 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.

Conditions

Anterior Cruciate Ligament Reconstruction

Keywords

Anterior Cruciate Ligament Reconstruction Predictive Factors; Function Downstairs walking Step time Symmetry

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (27)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Haraldsplass Deaconess Hospital: lead
• University of Bergen: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

Haraldsplass Deaconess hospital

Bergen, 5096, Norway

RECRUITING

Related Publications (24)

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Study Officials

• Willemijn Vervaat, MSc

  Haraldsplass Deaconess Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willemijn Vervaat, MSc

CONTACT

004755978618; wive@haraldsplass.no

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: January 19, 2011
• Study Start: October 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 18, 2013

Record last verified: 2013-01

Locations

NO (1)