Welcome
Support Centre
01 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial
ISRCTN ISRCTN84752559
DOI 10.1186/ISRCTN84752559
ClinicalTrials.gov identifier
EudraCT number
Public title Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial
Scientific title
Acronym KANON
Serial number at source N/A
Study hypothesis To compare the short-term (2 years) and long-term (5 years) outcome of surgical and non-surgical treatment of acute ACL disruptions in a physically active population. The primarily effective hypothesis will be evaluated with a disease-specific patient-relevant questionnaire (Knee injury and Osteoarthritis Outcome Score [KOOS]), the number of treatment failures and the return to pre-injury activity level.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Sweden
Disease/condition/study domain Anterior cruciate ligament rupture of the knee
Participants - inclusion criteria 1. Age 18-35 at entry
2. A history of a knee sprain not more than 4 weeks before inclusion
3. An ACL insufficiency as determined by clinical examination (positive Lachman test and positive pivot shift) and a complete ACL tear as visualized on Magnetic Resonance Imaging (MRI)
4. Activity level 5-9 by Tegner classification
5. A plain radiographic examination with normal joint status or with a small avulsed lateral fragment or grade 1 osteophyte or grade 1 joint space narrowing as determined by the Osteoarthritis Research Society International (OARSI) atlas
Participants - exclusion criteria 1. Pregnancy
2. Earlier major knee injury or knee surgery other than diagnostic arthroscopy on either knee
3. One of the following associated injuries on either knee:
3.1. Grade III medial collateral ligament injury
3.2. An injury to the lateral/posterolateral ligament complex with significantly increased laxity
3.3. Posterior Cruciate Ligament (PCL) injury
3.4. An unstable meniscus tear that requires repair and post-operative treatment interfering with the rehabilitation protocol
3.5. Bi-compartmental extensive meniscus resections
4. A cartilage injury representing a full thickness loss down to bone visualized on MRI
5. Joint space narrowing (JSN) grade 1 combined with osteophytes or JSN grade 2 or greater in the index or contralateral knee as classified by the OARSI atlas
6. A history of deep vein thrombosis (DVT) or a disorder of the coagulative system
7. Refusing to undergo radiological or surgical interventions due to claustrophobia, etc.
8. General disease that affects physical function or systemic medication/abuse of steroids
9. Any other condition or treatment interfering with the completion of the trial, including patients with metal devices or motion disorders etc. that will be unable to complete MRI examination
Anticipated start date 15/01/2002
Anticipated end date 31/12/2005
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 120
Interventions Surgery and structured rehabilitation compared with structured rehabilitation only.
Primary outcome measure(s) 1. KOOS and SF-36 patient-administered questionnaire scores, and number of treatment failures at 2 and 5 years
2. At 5 years, number and grade of joint changes, including bone marrow and meniscus lesions, assessed by radiographs and MRI
Secondary outcome measure(s) Knee joint laxity, physical activity level, and molecular markers of joint tissue turnover
Sources of funding 1. Lund University Medical Faculty (Sweden)
2. Region Skåne (Sweden)
3. Pfizer Research (USA)
4. Swedish Research Council (Sweden)
5. Swedish Research Council for Sports Medicine (Sweden)
6. Swedish Rheumatism Association (Sweden)
7. Zoega and Gorthon Foundations (Sweden)
Trial website
Publications 1. 2009 qualitative study results in: http://www.ncbi.nlm.nih.gov/pubmed/19664258
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20660401
3. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23349407
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24029859
5. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24867633
Contact name Prof  Stefan  Lohmander
  Address Clinical Sciences Lund
Department of Orthopedics
Lund University Hospital
  City/town Lund
  Zip/Postcode SE-22185
  Country Sweden
  Tel +46 46 171503
  Email stefan.lohmander@med.lu.se
Sponsor Lund University Medical Faculty (Sweden)
  Address PO Box 117
  City/town Lund
  Zip/Postcode SE-22100
  Country Sweden
  Email irene.barsegard@med.lu.se
  Sponsor website: http://www.med.lu.se
Date applied 21/10/2005
Last edited 29/05/2014
Date ISRCTN assigned 10/01/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.