|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries - a randomised prospective clinical trial |
| ISRCTN | ISRCTN84752559 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 four 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 contra lateral 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 | |
| Target number of participants | 120 |
| Interventions | Surgery and structured rehabilitation compared with structured rehabilitation only. |
| Primary outcome measure(s) |
KOOS and SF-36 patient-administered questionnaire scores, and number of treatment failures at two and five years.
At five 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 |
| 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 |
| stefan.lohmander@med.lu.se | |
| Sponsor | Lund University Medical Faculty (Sweden) |
| Address | PO Box 117 |
| City/town | Lund |
| Zip/Postcode | SE-22100 |
| Country | Sweden |
| irene.barsegard@med.lu.se | |
| Sponsor website: | http://www.med.lu.se |
| Date applied | 21/10/2005 |
| Last edited | 30/07/2010 |
| Date ISRCTN assigned | 10/01/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|