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Short-term efficacy and re-entry motion analysis of LARS artificial ligament enhanced autologous hamstring tendon reconstruction of anterior cruciate ligament reconstruction

Short-term efficacy and re-entry motion analysis of LARS artificial ligament enhanced autologous hamstring tendon reconstruction of anterior cruciate ligament reconstruction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127425
Enrollment
Unknown
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

anterior cruciate ligament injury

Interventions

Interventional group:Using centrally braided graft composed of autologous hamstring tendon combined with LARS artificial ligament
Control group:Using simple autologous hamstring tendon graft

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-50 years old, maintained a high level of exercise before injury, Tegner motor function score >= 6 points. 2.The diagnosis of unilateral anterior cruciate ligament ( ACL ) complete rupture was confirmed by clinical examination ( Lachman test positive, pivot shift test positive ) and knee MRI. 3.The function of the healthy knee joint was normal, and there was no ligament rupture or operation history. 4.The patients were fully informed and willing to accept randomization ( including possible inclusion in the LARS group and bearing the corresponding consumables costs ), voluntarily signed written informed consent, and were able to cooperate with the completion of the 12-month follow-up and rehabilitation plan.

Exclusion criteria

Exclusion criteria: 1.MRI or intraoperative exploration confirmed multiple ligament injuries such as posterior cruciate ligament ( PCL ), medial collateral ligament ( MCL ) II and above, lateral collateral ligament ( LCL ) or posterolateral corner ( PLC ). 2.MRI or intraoperative arthroscopic exploration showed that there was severe cartilage injury in the affected knee ( Outerbridge grade 3 or above ). 3.The affected knee had a history of surgery ; combined with rheumatoid arthritis, suppurative arthritis and other joint diseases ; patients with severe cardiovascular, liver and kidney dysfunction or severe diabetes and other major systemic diseases that affect surgery and postoperative rehabilitation. 4.After the hamstring tendon was cut during the operation, the diameter of the folded graft was measured to be less than 8mm .

Design outcomes

Primary

MeasureTime frame
return-to-motion rate;

Secondary

MeasureTime frame
difference of forward laxity between knees;lysholm knee rating scale;pivot-shift test;skip test;tibial tunnel width;isokinetic test;international knee documentation committee subjective knee assessment scale;visual analog scale method;anterior cruciate ligament-return to sport after injury;graft maturity;return to exercise time;

Countries

China

Contacts

Public ContactZhou Jingbin

Beijing Chao-Yang Hospital, Capital Medical University

jingbinzhou@163.com+86 10 50125012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026