Plain English Summary
Background and study aims
Anterior cruciate ligament (ACL) injury is a very common sports injury. It is reported that there are about 2 million cases of ACL injuries worldwide each year. ACL reconstruction (ACLR) is the main and standard surgery for ACL injury. Despite the development of techniques, grafts, and rehabilitation, 10-30% of patients still have rotational instability after isolated ACLR, increasing the risk of graft rupture, affecting patient movement and delaying patient recovery. The aim of this study is to explore the clinical outcomes of combining ACL reconstruction and anterolateral structure (ALS) reconstruction through a modified single femoral tunnel in patients with a high risk of clinical failure.
Who can participate?
Patients aged under 50 years undergoing ACLR combined with ALS reconstruction from December 2018 to August 2022
What does the study involve?
All procedures were performed by the same experienced surgeon. All patients received similar perioperative management programs. Measurements included function, stability and safety evaluations at different time points (preoperative, postoperative, 3 months, 6 months, 1 year, 2 years, 3 years and more).
What are the possible benefits and risks of participating?
Possible risks of the surgery include deep venous thrombosis, knee joint stiffness, and acute knee infection.
Where is the study run from?
Luoyang Orthopedic Hospital of Henan Province, Orthopedic Hospital of Henan Province (China)
When is the study starting and how long is it expected to run for?
June 2017 to December 2022
Who is funding the study?
1. National Natural Science Foundation of China
2. Project of Science and Technology of Henan Province (China)
Who is the main contact?
Guorui Cao, 13688172272@163.com
Study website
Contact information
Type
Public, Scientific, Principal Investigator
Contact name
Prof Honglue Tan
ORCID ID
Contact details
82 Qiming South Road
Luoyang
621000
China
+86 (0)15036358806
hnlc.love@163.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Meniscus surgical treatment demonstrated inferior clinical outcomes as no meniscus injury with simultaneous combined anterior cruciate ligament and anterolateral structure reconstruction: a case-controlled study
Acronym
Study hypothesis
Patients without meniscus injury have superior clinical outcomes. Meniscus repair and partial meniscectomy with simultaneous anterior cruciate ligament (ACL) and anterolateral structure (ALS) reconstruction could result in equivalent clinical outcomes.
Ethics approval(s)
Approved 10/10/2023, Luoyang Orthopedic Hospital of Henan Province (82 Qiming South Road, Luoyang, 621000, China; +86 (0)37963536160; smxwx@163.com), ref: 2023ZXKT005-01
Study design
Retrospective case controlled study
Primary study design
Observational
Secondary study design
Case-control study
Study setting(s)
Training facility/simulation
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Combined anterior cruciate ligament and anterolateral structure reconstruction
Intervention
From December 2018 to August 2022, a total of 62 patients with ACL injury were enrolled in this study. All patients were associated with a high risk of clinical failure, meeting the indications of ALS augmentation, including 47 males and 15 females, aged 16-52 years with an average age of 29.3 ± 9.2 years. All patients accepted arthroscopic single-bundle ACL reconstruction and ALS reconstruction using hamstring autograft through a modified single femoral tunnel. Perioperative clinical outcome measurements comprised function, stability and safety evaluations at different time points (preoperative, postoperative 3 months, 6 months, 1 year, 2 years, 3 years and more). The functional evaluation included the Lysholm score, Tegner activity scale, and subjective and objective International Knee Documentation Committee (IKDC) score.
Intervention type
Procedure/Surgery
Primary outcome measure
Knee-specific symptoms measured using the Lysholm score at preoperative, postoperative 3 months, 6 months, 1 year, 2 years, 3 years and more
Secondary outcome measures
1. Sports activity measured using the Tegner activity scale at preoperative, postoperative 3 months, 6 months, 1 year, 2 years, 3 years and more
2. Knee function measured using the subjective and objective International Knee Documentation Committee (IKDC) score at preoperative, postoperative 3 months, 6 months, 1 year, 2 years, 3 years and more
Overall study start date
27/06/2017
Overall study end date
30/12/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with ACL and ALS reconstruction through single femoral tunnel
2. Aged 16-52 years
3. No history of previous ipsilateral knee injury and surgery
Participant type(s)
Patient
Age group
Adult
Lower age limit
16 Years
Upper age limit
52 Years
Sex
Both
Target number of participants
103
Total final enrolment
62
Participant exclusion criteria
1. Multiple ligament injuries
2. ACL rupture associated with fracture
3. ACL revision
4. Significant degree of osteoarthritis (OA) or cartilage damage
5. Skeletally immature or incomplete medical records
Recruitment start date
01/12/2018
Recruitment end date
30/08/2022
Locations
Countries of recruitment
China
Study participating centre
Luoyang Orthopedic Hospital of Henan Province
82 Qiming South Road
Luoyang
471000
China
Sponsor information
Organisation
Luoyang Orthopedic-Traumatological Hospital of Henan Province
Sponsor details
82 Qiming South Road
Luoyang
621000
China
+86 (0)13688172272
825118087@qq.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Natural Science Foundation of China (82104896)
Alternative name(s)
Chinese National Science Foundation, Natural Science Foundation of China, National Science Foundation of China, NNSF of China, NSF of China, 国家自然科学基金委员会, National Nature Science Foundation of China, Guójiā Zìrán Kēxué Jījīn Wěiyuánhuì, NSFC, NNSF, NNSFC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
China
Funder name
Project of Science and Technology of Henan Province
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
15/12/2024
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from Guorui Cao (13688172272@163.com)
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|