Anterior Cruciate Ligament ReconstructionNCT01279759
Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction
An observational study of Anterior Cruciate Ligament Reconstruction, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction
- How many people
- 35 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients planned for reconstruction of the anterioir crucuate ligament with hamstrings graft.
Who may be able to join
- Patients planned for reconstruction of the anterior cruciate ligament with hamstrings graft at Haraldsplass Deaconess hospital.
Who cannot join
- Patients with multiligament tears, meniscus suture, other problems that can influence strength testing, functional testing and gait symmetry.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haraldsplass Deaconess hospital
Bergen, 5096
Solveig Ullaland, 0047-55978541
Willemijn Vervaat, MSc
About this study
Official title: Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction
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.
Read more
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.
Read the 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.
- Keywords
- Anterior Cruciate Ligament Reconstruction Predictive Factors, Function Downstairs walking Step time Symmetry
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperatively
Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX).
Measured: 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).
Measured: 6 months postoperatively
Self reported function.
International Knee Documentation Committee 2000 subjective knee evaluation form.
Measured: 6 months post operatively
Secondary outcomes (27)
Pain scores on a visual analog scale
Measured: 1 day preoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Measured: 1 day preoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Measured: 1 day preoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Measured: 1 day preoperatively
Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX)
Measured: 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.
Measured: 1 day preoperatively
Self reported function
International Knee Documentation Committee 2000 subjective knee evaluation form
Measured: 1 day preoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Measured: 1 day preoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Measured: at discharge
Pain scores on a visual analog scale.
Measured: at discharge
Difficulties with walking downstairs on a visual analog scale.
Measured: 1 day preoperative
Pain scores on a visual analog scale.
Measured: 6 weeks post operatively
Difficulties with walking down stairs on a visual analog scale.
Measured: 6 weeks postoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Measured: 6 weeks postoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Measured: 6 weeks postoperatively
Passive range of movement compared to the healthy knee will be measured with a goniometer.
Measured: 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.
Measured: 6 weeks postoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Measured: 6 weeks postoperatively
Knee joint laxity measured with knee laxity testing device (KT 1000).
Measured: 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.
Measured: 3 months postoperatively
Pain scores on a visual analog scale.
Measured: 3 months postoperatively
Difficulties with walking down stairs on a visual analog scale.
Measured: 3 months postoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Measured: 3 months postoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Measured: 3 months postoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Measured: 3 months postoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Measured: 3 months postoperatively
Knee joint laxity measured with a knee laxity testing device (KT 1000).
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2011 (estimated)
- Study startOct 2010
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Willemijn Vervaat, MSc, Principal investigator, Haraldsplass Deaconess Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01279759
- Sponsor's protocol ID
- 01339
- Status last verified
- Jan 2013
- First submitted
- 8 Nov 2010
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1002/pri.289.
PubMed 14730723Arvidsson 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. doi: 10.3928/0147-7447-19861101-08.
PubMed 3491982Bjordal 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. doi: 10.1177/036354659702500312.
PubMed 9167814Daniel 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. doi: 10.1177/036354659402200511.
PubMed 7810787de 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. doi: 10.1016/j.arthro.2006.08.024.
PubMed 17210423Drechsler 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. doi: 10.1007/s00421-006-0311-9. Epub 2006 Oct 12.
PubMed 17036217Eitzen 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.
PubMed 19224907Helbostad 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.
PubMed 19487126Hodt-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. doi: 10.1016/j.gaitpost.2007.07.015. Epub 2007 Sep 25.
PubMed 17897830Holder-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. doi: 10.1007/s004210100474.
PubMed 11560085Johansson H, Sjolander 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.
PubMed 2036801Kowalchuk 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.
PubMed 19409302McHugh 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. doi: 10.1177/03635465020300030601.
PubMed 12016072Moe-Nilssen R. A new method for evaluating motor control in gait under real-life environmental conditions. Part 2: Gait analysis. Clin Biomech (Bristol). 1998 Jun;13(4-5):328-335. doi: 10.1016/s0268-0033(98)00090-4.
PubMed 11415804Moe-Nilssen R. A new method for evaluating motor control in gait under real-life environmental conditions. Part 1: The instrument. Clin Biomech (Bristol). 1998 Jun;13(4-5):320-327. doi: 10.1016/s0268-0033(98)00089-8.
PubMed 11415803
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01279759
- Acronym / sponsor ID
- 01339
- Keywords
- Anterior Cruciate Ligament Reconstruction Predictive Factors, Function Downstairs walking Step time Symmetry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Oct 2010
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 19 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients planned for reconstruction of the anterioir crucuate ligament with hamstrings graft.
Key inclusion criteria (1 listed)
- Patients planned for reconstruction of the anterior cruciate ligament with hamstrings graft at Haraldsplass Deaconess hospital.
Key exclusion criteria (1 listed)
- Patients with multiligament tears, meniscus suture, other problems that can influence strength testing, functional testing and gait symmetry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asymmetry in step time between the affected and unaffected leg during down stairs walking.
Time frame: 6 months postoperatively
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
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
Self reported function.
Time frame: 6 months post operatively
International Knee Documentation Committee 2000 subjective knee evaluation form.
27 secondary outcomes
Pain scores on a visual analog scale
Time frame: 1 day preoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Time frame: 1 day preoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Time frame: 1 day preoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Time frame: 1 day preoperatively
Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX)
Time frame: 1 day preoperatively
Asymmetry in step time between the affected and unaffected leg during down stairs walking.
Time frame: 1 day preoperatively
Self reported function
Time frame: 1 day preoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Time frame: 1 day preoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Time frame: at discharge
Pain scores on a visual analog scale.
Time frame: at discharge
Difficulties with walking downstairs on a visual analog scale.
Time frame: 1 day preoperative
Pain scores on a visual analog scale.
Time frame: 6 weeks post operatively
Difficulties with walking down stairs on a visual analog scale.
Time frame: 6 weeks postoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Time frame: 6 weeks postoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Time frame: 6 weeks postoperatively
Passive range of movement compared to the healthy knee will be measured with a goniometer.
Time frame: 6 weeks postoperatively
Asymmetry in step time between the affected and unaffected leg during down stairs walking.
Time frame: 6 weeks postoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Time frame: 6 weeks postoperatively
Knee joint laxity measured with knee laxity testing device (KT 1000).
Time frame: 6 weeks postoperatively
Asymmetry in step time between the affected and unaffected leg during down stairs walking.
Time frame: 3 months postoperatively
Pain scores on a visual analog scale.
Time frame: 3 months postoperatively
Difficulties with walking down stairs on a visual analog scale.
Time frame: 3 months postoperatively
Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).
Time frame: 3 months postoperatively
The circumference around the center of the patella will be measured to assess for swelling around the knee joint.
Time frame: 3 months postoperatively
Passive range of movement compared to the healthy knee, measured with a goniometer.
Time frame: 3 months postoperatively
Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.
Time frame: 3 months postoperatively
Knee joint laxity measured with a knee laxity testing device (KT 1000).
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2013.
- Background: PubMed 14730723Adlerton 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. doi: 10.1002/pri.289.
- Background: PubMed 3491982Arvidsson 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. doi: 10.3928/0147-7447-19861101-08.
- Background: PubMed 9167814Bjordal 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. doi: 10.1177/036354659702500312.
- Background: PubMed 7810787Daniel 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. doi: 10.1177/036354659402200511.
- Background: PubMed 17210423de 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. doi: 10.1016/j.arthro.2006.08.024.
- Background: PubMed 17036217Drechsler 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. doi: 10.1007/s00421-006-0311-9. Epub 2006 Oct 12.
- Background: PubMed 19224907Eitzen 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.
- Background: PubMed 19487126Helbostad 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.
- Background: PubMed 17897830Hodt-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. doi: 10.1016/j.gaitpost.2007.07.015. Epub 2007 Sep 25.
- Background: PubMed 11560085Holder-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. doi: 10.1007/s004210100474.
- Background: PubMed 2036801Johansson H, Sjolander 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.
- Background: PubMed 19409302Kowalchuk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willemijn Vervaat, MSc principal investigator
Haraldsplass Deaconess Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Reconstruction, run by Haraldsplass Deaconess Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Willemijn Vervaat, MSc (004755978618, wive@haraldsplass.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asymmetry in step time between the affected and unaffected leg during down stairs walking. (time frame: 6 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01279759, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2013.