Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stefan Lohmander

ORCID ID

Contact details

Clinical Sciences Lund
Department of Orthopedics
Lund University Hospital
Lund
SE-22185
Sweden
+46 46 171503
stefan.lohmander@med.lu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Other

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Anterior cruciate ligament rupture of the knee

Intervention

Surgery and structured rehabilitation compared with structured rehabilitation only.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

Knee joint laxity, physical activity level, and molecular markers of joint tissue turnover

Overall trial start date

15/01/2002

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

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

Trial participating centre

Clinical Sciences Lund
Lund
SE-22185
Sweden

Sponsor information

Organisation

Lund University Medical Faculty (Sweden)

Sponsor details

PO Box 117
Lund
SE-22100
Sweden
irene.barsegard@med.lu.se

Sponsor type

Industry

Website

http://www.med.lu.se

Funders

Funder type

Industry

Funder name

Lund University Medical Faculty (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Region Skåne (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Research (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Research Council (Sweden)

Alternative name(s)

Swedish Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Swedish Research Council for Sports Medicine (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Rheumatism Association (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Zoega and Gorthon Foundations (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Qualitative study results

    Thorstensson CA, Lohmander LS, Frobell RB, Roos EM, Gooberman-Hill R, Choosing surgery: patients' preferences within a trial of treatments for anterior cruciate ligament injury. A qualitative study., BMC Musculoskelet Disord, 2009, 10, 100, doi: 10.1186/1471-2474-10-100.

  2. Results

    Frobell RB, Roos EM, Roos HP, Ranstam J, Lohmander LS, A randomized trial of treatment for acute anterior cruciate ligament tears., N. Engl. J. Med., 2010, 363, 4, 331-342, doi: 10.1056/NEJMoa0907797.

  3. Results

    Frobell RB, Roos HP, Roos EM, Roemer FW, Ranstam J, Lohmander LS, Treatment for acute anterior cruciate ligament tear: five year outcome of randomised trial., BMJ, 2013, 346, f232.

  4. Results

    Ericsson YB, Roos EM, Frobell RB, Lower extremity performance following ACL rehabilitation in the KANON-trial: impact of reconstruction and predictive value at 2 and 5 years., Br J Sports Med, 2013, 47, 15, 980-985, doi: 10.1136/bjsports-2013-092642.

  5. Results

    Hunter DJ, Lohmander LS, Makovey J, Tamez-Peña J, Totterman S, Schreyer E, Frobell RB, The effect of anterior cruciate ligament injury on bone curvature: exploratory analysis in the KANON trial., Osteoarthr. Cartil., 2014, 22, 7, 959-968, doi: 10.1016/j.joca.2014.05.014.

Editorial Notes