Combined surgical approach: simultaneous reconstruction of anterior cruciate ligament and anterolateral structures through a modified single femoral tunnel technique
| ISRCTN | ISRCTN80922346 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80922346 |
- Submission date
- 27/02/2024
- Registration date
- 06/05/2024
- Last edited
- 14/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public, Scientific, Principal Investigator
82 Qiming South Road
Luoyang
621000
China
| Phone | +86 (0)15036358806 |
|---|---|
| hnlc.love@163.com |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/12/2022 |
Eligibility
| 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 30/08/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Luoyang
471000
China
Sponsor information
Hospital/treatment centre
82 Qiming South Road
Luoyang
621000
China
| Phone | +86 (0)13688172272 |
|---|---|
| 825118087@qq.com |
Funders
Funder type
Government
Government organisation / National government
- 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
- Location
- China
No information available
Results and Publications
| Intention to publish date | 15/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 13/08/2025 | 14/08/2025 | Yes | No |
Editorial Notes
14/08/2024: Publication reference added.
11/03/2024: Study's existence confirmed by the Luoyang Orthopedic Hospital of Henan Province.
