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
Secondary identifying numbers	N/A

Submission date: 21/10/2005
Registration date: 10/01/2006
Last edited: 07/01/2025

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

Not provided at time of registration

Contact information

Prof Stefan Lohmander
Scientific

Clinical Sciences Lund
Department of Orthopedics
Lund University Hospital
Lund
SE-22185
Sweden

Phone	+46 (0)46 171503
Email	stefan.lohmander@med.lu.se

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial
Study acronym	KANON
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.
Ethics approval(s)	Not provided at time of registration
Condition	Anterior cruciate ligament rupture of the knee
Intervention	Surgery and structured rehabilitation compared with structured rehabilitation only.
Intervention type	Other
Primary outcome measure	1. KOOS and SF-36 patient-administered questionnaire scores, and number of treatment failures at 2 and 5 years 2. Number and grade of joint changes, including bone marrow and meniscus lesions, assessed by radiographs and MRI at 5 years
Secondary outcome measures	Knee joint laxity, physical activity level, and molecular markers of joint tissue turnover
Overall study start date	15/01/2002
Overall study end date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	35 Years
Sex	Both
Target number of participants	120
Total final enrolment	121
Participant 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
Participant 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
Recruitment start date	15/01/2002
Recruitment end date	31/12/2005

Locations

Countries of recruitment

Sweden

Study participating centre

Lund University Hospital

Lund
SE-22185
Sweden

Sponsor information

Lund University Medical Faculty (Sweden)
Industry

PO Box 117
Lund
SE-22100
Sweden

Email	irene.barsegard@med.lu.se
Website	http://www.med.lu.se
"ROR"	https://ror.org/012a77v79

Funders

Funder type

Industry

Medicinska Fakulteten, Lunds Universitet
Government organisation / Local government

Alternative name(s): Faculty of Medicine, Lund University
Location: Sweden

Region Skåne (Sweden)

No information available

Pfizer
Government organisation / For-profit companies (industry)

Alternative name(s): Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
Location: United States of America

Swedish Research Council (Sweden)
Government organisation / National government

Alternative name(s): Swedish Research Council, VR
Location: Sweden

Swedish Research Council for Sports Medicine (Sweden)

No information available

Swedish Rheumatism Association (Sweden)

No information available

Zoega and Gorthon Foundations (Sweden)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
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
Other publications	exploratory analysis	01/09/2017		Yes	No
Other publications	exploratory analysis	01/11/2017		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

Editorial Notes

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.