Surgical versus non-surgical treatment of anterior cruciate ligament (ACL) injuries: a randomised prospective clinical trial

Not Applicable

Completed

• Conditions: Anterior cruciate ligament rupture of the knee; Skin and Connective Tissue Diseases; Anterior Cruciate Ligament (ACL)

• Registration Number: ISRCTN84752559
• Lead Sponsor: und University Medical Faculty (Sweden)

Brief Summary

2009 Results article in http://www.ncbi.nlm.nih.gov/pubmed/19664258 qualitative study results 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20660401 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23349407 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24029859 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24867633 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25252019 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26935859 results 2017 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/28522220 exploratory analysis 2017 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/28515057 exploratory analysis 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31653779 secondary analysis results (added 29/10/2019) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33549723/ results (added 09/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33676015/ results on association between meniscal integrity and early bone surface area changes (added 08/03/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33687286/ 5-year follow up results (added 10/03/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36328403/ Secondary analysis of participants randomised to rehabilitation and optional delayed ACL reconstruction (ACLR) or early ACLR and rehabilitation (added 04/11/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2005-12-31
• Study Start: 2006-01-10
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 121

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified