Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-27 @ 2:07 AM
Study NCT ID:
NCT01279759
Status:
UNKNOWN
Last Update Posted:
2013-01-18
First Post:
2010-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2010-11-08', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asymmetry in step time between the affected and unaffected leg during down stairs walking.', 'timeFrame': '6 months postoperatively', 'description': '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.'}, {'measure': 'Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX).', 'timeFrame': '6 months postoperatively'}, {'measure': '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).', 'timeFrame': '6 months postoperatively'}, {'measure': 'Self reported function.', 'timeFrame': '6 months post operatively', 'description': 'International Knee Documentation Committee 2000 subjective knee evaluation form.'}], 'secondaryOutcomes': [{'measure': 'Pain scores on a visual analog scale', 'timeFrame': '1 day preoperatively'}, {'measure': 'Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).', 'timeFrame': '1 day preoperatively'}, {'measure': 'The circumference around the center of the patella will be measured to assess for swelling around the knee joint.', 'timeFrame': '1 day preoperatively'}, {'measure': 'Passive range of movement compared to the healthy knee, measured with a goniometer.', 'timeFrame': '1 day preoperatively'}, {'measure': 'Isokinetic muscle strength measured with a fixed dynamometer (isok BI con/con 60/60 240/240 BIODEX)', 'timeFrame': '1 day preoperatively'}, {'measure': 'Asymmetry in step time between the affected and unaffected leg during down stairs walking.', 'timeFrame': '1 day preoperatively', 'description': '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.'}, {'measure': 'Self reported function', 'timeFrame': '1 day preoperatively', 'description': 'International Knee Documentation Committee 2000 subjective knee evaluation form'}, {'measure': 'Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.', 'timeFrame': '1 day preoperatively'}, {'measure': 'Passive range of movement compared to the healthy knee, measured with a goniometer.', 'timeFrame': 'at discharge'}, {'measure': 'Pain scores on a visual analog scale.', 'timeFrame': 'at discharge'}, {'measure': 'Difficulties with walking downstairs on a visual analog scale.', 'timeFrame': '1 day preoperative'}, {'measure': 'Pain scores on a visual analog scale.', 'timeFrame': '6 weeks post operatively'}, {'measure': 'Difficulties with walking down stairs on a visual analog scale.', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'The circumference around the center of the patella will be measured to assess for swelling around the knee joint.', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'Passive range of movement compared to the healthy knee will be measured with a goniometer.', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'Asymmetry in step time between the affected and unaffected leg during down stairs walking.', 'timeFrame': '6 weeks postoperatively', 'description': '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.'}, {'measure': 'Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'Knee joint laxity measured with knee laxity testing device (KT 1000).', 'timeFrame': '6 weeks postoperatively'}, {'measure': 'Asymmetry in step time between the affected and unaffected leg during down stairs walking.', 'timeFrame': '3 months postoperatively', 'description': '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.'}, {'measure': 'Pain scores on a visual analog scale.', 'timeFrame': '3 months postoperatively'}, {'measure': 'Difficulties with walking down stairs on a visual analog scale.', 'timeFrame': '3 months postoperatively'}, {'measure': 'Degree of swelling measured with The Modified Stroke Test (Logerseth at al, 2010).', 'timeFrame': '3 months postoperatively'}, {'measure': 'The circumference around the center of the patella will be measured to assess for swelling around the knee joint.', 'timeFrame': '3 months postoperatively'}, {'measure': 'Passive range of movement compared to the healthy knee, measured with a goniometer.', 'timeFrame': '3 months postoperatively'}, {'measure': 'Muscle atrophy in the quadriceps muscle will be measured 12 and 17 cm above the medial knee joint line.', 'timeFrame': '3 months postoperatively'}, {'measure': 'Knee joint laxity measured with a knee laxity testing device (KT 1000).', 'timeFrame': '3 months postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament Reconstruction Predictive Factors', 'Function Downstairs walking Step time Symmetry'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '14730723', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '3491982', 'type': 'BACKGROUND', '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. doi: 10.3928/0147-7447-19861101-08.'}, {'pmid': '9167814', 'type': 'BACKGROUND', '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. doi: 10.1177/036354659702500312.'}, {'pmid': '7810787', 'type': 'BACKGROUND', '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. doi: 10.1177/036354659402200511.'}, {'pmid': '17210423', 'type': 'BACKGROUND', '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. doi: 10.1016/j.arthro.2006.08.024.'}, {'pmid': '17036217', 'type': 'BACKGROUND', '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. doi: 10.1007/s00421-006-0311-9. Epub 2006 Oct 12.'}, {'pmid': '19224907', 'type': 'BACKGROUND', '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.'}, {'pmid': '19487126', 'type': 'BACKGROUND', '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.'}, {'pmid': '17897830', 'type': 'BACKGROUND', '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. doi: 10.1016/j.gaitpost.2007.07.015. Epub 2007 Sep 25.'}, {'pmid': '11560085', 'type': 'BACKGROUND', '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. doi: 10.1007/s004210100474.'}, {'pmid': '2036801', 'type': 'BACKGROUND', 'citation': 'Johansson 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.'}, {'pmid': '19409302', 'type': 'BACKGROUND', '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.'}, {'pmid': '12016072', 'type': 'BACKGROUND', '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. doi: 10.1177/03635465020300030601.'}, {'pmid': '11415804', 'type': 'BACKGROUND', '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). 1998 Jun;13(4-5):328-335. doi: 10.1016/s0268-0033(98)00090-4.'}, {'pmid': '11415803', 'type': 'BACKGROUND', '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). 1998 Jun;13(4-5):320-327. doi: 10.1016/s0268-0033(98)00089-8.'}, {'pmid': '16531394', 'type': 'BACKGROUND', '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. doi: 10.3200/JMBR.38.2.118-125.'}, {'pmid': '14623667', 'type': 'BACKGROUND', '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. doi: 10.1177/03635465030310063901.'}, {'pmid': '1962720', 'type': 'BACKGROUND', '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. doi: 10.1177/036354659101900518.'}, {'pmid': '19954822', 'type': 'BACKGROUND', '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.'}, {'pmid': '17300940', 'type': 'BACKGROUND', '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. doi: 10.1016/j.gaitpost.2007.01.001. Epub 2007 Feb 14.'}, {'pmid': '8250616', 'type': 'BACKGROUND', 'citation': 'Young A. Current issues in arthrogenous inhibition. Ann Rheum Dis. 1993 Nov;52(11):829-34. doi: 10.1136/ard.52.11.829.'}, {'pmid': '19508651', 'type': 'BACKGROUND', '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.'}, {'pmid': '17895440', 'type': 'BACKGROUND', '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. doi: 10.1093/gerona/62.9.1010.'}, {'pmid': '15235310', 'type': 'BACKGROUND', '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. doi: 10.1249/01.mss.0000131959.20666.11.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nAn 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.\n\nPhysical 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.\n\nIt 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).\n\nPurpose:\n\n1. To analyse which pre and post operative factors can predict measured and patient reported function 6 months after Anterior Cruciate Ligament reconstruction.\n2. 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.', 'detailedDescription': 'Methods:\n\nThe investigators wish to recruit 35 people scheduled for anterior cruciate ligament (ACL) reconstruction with hamstrings tendon graft.\n\nPatients will be asked to write a training diary.\n\nData will be collected 1 day preoperatively, 2 days, 6 weeks, 3 months and 6 months post operatively.\n\nEthics:\n\nAll participants will have to give informed consent before inclusion. All information obtained through the surveys will be treated confidentially. Participation is completely voluntary.\n\nReferences:\n\nGRANAN, L., ENGEBRETSEN, L. \\& BAHR, R. (2004) Kirurgi ved fremre korsbåndskader i Norge - sett fra et idrettsmedisinsk perspektiv. Tidsskr Nor Lægeforen, 124, 928-930.\n\nNASJONALT REGISTER FOR LEDDPROTESER (2009) Nasjonalt korsbåndregister. Ortopedisk klinikk Haukeland Universitets Sykehus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients planned for reconstruction of the anterioir crucuate ligament with hamstrings graft.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients planned for reconstruction of the anterior cruciate ligament with hamstrings graft at Haraldsplass Deaconess hospital.\n\nExclusion Criteria:\n\n* Patients with multiligament tears, meniscus suture, other problems that can influence strength testing, functional testing and gait symmetry.'}, 'identificationModule': {'nctId': 'NCT01279759', 'briefTitle': 'Follow up of Patients Operated With Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Haraldsplass Deaconess Hospital'}, 'officialTitle': 'Pre- and Post Operative Predictive Factors for Function 6 Months After Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '01339'}}, 'contactsLocationsModule': {'locations': [{'zip': '5096', 'city': 'Bergen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Solveig Ullaland', 'role': 'CONTACT', 'phone': '0047-55978541'}, {'name': 'Willemijn Vervaat, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rolf Moe-Nilssen, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Bård Bogen, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas Harlem, surgeon', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rune Børnes, physiot.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gro Hilde Vik, physiot', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anne Gro Faleide, physiot', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Grete Utkilen, physiot.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Grethe Gjendemsjø, physiot', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Synnøve Misje, Physiot.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Haraldsplass Deaconess hospital', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'centralContacts': [{'name': 'Willemijn Vervaat, MSc', 'role': 'CONTACT', 'email': 'wive@haraldsplass.no', 'phone': '004755978618'}], 'overallOfficials': [{'name': 'Willemijn Vervaat, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haraldsplass Deaconess Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haraldsplass Deaconess Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Bergen', 'class': 'OTHER'}, {'name': 'Norwegian Fund for Postgraduate Training in Physiotherapy', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}