Skip to content

Comparison of the efficacy of ACL reconstruction augmented with Internal Brace technique and standard ACL reconstruction after reconstruction in patients with ACL rupture: a clinical trial with a randomized parallel design

Comparison of the efficacy of ACL reconstruction augmented with Internal Brace technique and standard ACL reconstruction after reconstruction in patients with ACL rupture: a clinical trial with a randomized parallel design

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057526
Enrollment
Unknown
Registered
2022-03-14
Start date
2022-03-14
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Group 1:ACL reconstruction +Internal Brace technique
Group 2:Standard ACL reconstruction

Sponsors

Central South University Xiangya Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 16 and 45 years; 2. Unilateral knee MRI showed ACL fracture in one knee, and the diagnosis was confirmed by arthroscopy; 3. With meniscus injury, the standard postoperative rehabilitation program will not be affected after surgical treatment; 4. The combination of grade III and below cartilage injury does not affect the standard postoperative rehabilitation program; 5. The follow-up period was 24 months; 6. No previous injury of healthy knee joint; 7. Subject gives informed consent and signs relevant documents.

Exclusion criteria

Exclusion criteria: 1. Previous ACL reconstruction or bilateral anterior cruciate ligament injury; 2. Posterior cruciate ligament (PCL), medial collateral ligament (MCL) or lateral collateral ligament (LCL) injury shown on MRI; 3. Unstable longitudinal meniscus tear requiring repair; 4. Patients with serious underlying diseases that are not suitable for surgery, or suffering from mental illness, pregnancy during the planned trial and other adverse follow-up.

Design outcomes

Primary

MeasureTime frame
IKDC score of knee joint;

Secondary

MeasureTime frame
Lysholm knee score;Knee injury and osteoarthritis outcome score (KOOS);Visual analogue scale score;Knee stability;Knee MRI;

Countries

China

Contacts

Public ContactXiao Wenfeng

Central South University Xiangya Hospital

xiaowenfeng@csu.edu.cn+86 13787043132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026