Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial
| ISRCTN | ISRCTN84752559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84752559 |
| Protocol serial number | N/A |
| Sponsor | Lund University Medical Faculty (Sweden) |
| Funders | Medicinska Fakulteten, Lunds Universitet, Region Skåne (Sweden), Pfizer, Swedish Research Council (Sweden), Swedish Research Council for Sports Medicine (Sweden), Swedish Rheumatism Association (Sweden), Zoega and Gorthon Foundations (Sweden) |
- Submission date
- 21/10/2005
- Registration date
- 10/01/2006
- Last edited
- 20/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stefan Lohmander
Scientific
Scientific
Clinical Sciences Lund
Department of Orthopedics
Lund University Hospital
Lund
SE-22185
Sweden
| Phone | +46 (0)46 171503 |
|---|---|
| stefan.lohmander@med.lu.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial |
| Study acronym | KANON |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Anterior cruciate ligament rupture of the knee |
| Intervention | Surgery and structured rehabilitation compared with structured rehabilitation only. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. KOOS and SF-36 patient-administered questionnaire scores, and number of treatment failures at 2 and 5 years |
| Key secondary outcome measure(s) |
Knee joint laxity, physical activity level, and molecular markers of joint tissue turnover |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 35 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 121 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/01/2002 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Lund University Hospital
Lund
SE-22185
Sweden
SE-22185
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | qualitative study results | 10/08/2009 | Yes | No | |
| Results article | results | 22/07/2010 | Yes | No | |
| Results article | results | 24/01/2013 | Yes | No | |
| Results article | results | 01/10/2013 | Yes | No | |
| Results article | results | 01/07/2014 | Yes | No | |
| Results article | results | 01/01/2015 | Yes | No | |
| Results article | results | 01/05/2016 | Yes | No | |
| Results article | secondary analysis results | 01/05/2020 | 29/10/2019 | Yes | No |
| Results article | results | 04/02/2021 | 09/02/2021 | Yes | No |
| Results article | results on association between meniscal integrity and early bone surface area changes | 03/03/2021 | 08/03/2021 | Yes | No |
| Results article | 5-year follow up results | 09/03/2021 | 10/03/2021 | Yes | No |
| Results article | Secondary analysis of participants randomised to rehabilitation and optional delayed ACL reconstruction (ACLR) or early ACLR and rehabilitation | 03/11/2022 | 04/11/2022 | Yes | No |
| Results article | Exploratory analysis | 03/01/2025 | 07/01/2025 | Yes | No |
| Results article | Association Between ACL Continuity on Magnetic Resonance Imaging at 5 Years After an Acute ACL Rupture and 11-Year Outcomes: A Secondary Analysis From the KANON Trial | 19/05/2025 | 20/05/2025 | Yes | No |
| Other publications | exploratory analysis | 01/09/2017 | Yes | No | |
| Other publications | exploratory analysis | 01/11/2017 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/05/2025: Publication reference added.
07/01/2025: Publication reference added.
04/11/2022: Publication reference added.
10/03/2021: Publication reference added.
08/03/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the referenc
09/02/2021: Publication reference added.
29/10/2019: Publication reference added.
22/05/2017: Publication reference added.
19/05/2017: Publication reference added.
07/03/2016: Publication reference added.
