Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02833454

Enrollment

320

Registered

2016-07-14

Start date

2016-07-31

Completion date

2018-08-31

Last updated

2016-07-15

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

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament

Brief summary

The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.

Detailed description

The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.

Interventions

PROCEDUREdirect insertion anterior cruciate ligament reconstruction

ACL reconstruction based on direct insertion of ACL.

PROCEDUREsingle bundle anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction using single bundle technique

PROCEDUREdouble bundle anterior cruciate ligament reconstruction

anterior cruciate ligament reconstruction using double bundle technique

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to 40 Years

Healthy volunteers

Inclusion criteria

* ACL rupture patients aged between 16 to 40 years

Exclusion criteria

* combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage \>2°, pathologic leg axis deviation) * any injury or surgery to the contralateral knee * any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Design outcomes

Primary

Measure	Time frame	Description
Lysholm score of the knee	two years	Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
Tegner score of the knee	two years	Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
IKDC score of the knee	two years	IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score

Secondary

Measure	Time frame	Description
KT-2000 of the knee	two years	KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.

Contacts

Primary ContactYu Jia-Kuo, MD

yujiakuo@126.com86-10-82267392

Backup ContactLiu Yang, MD

surgeonliuyang@sina.com86-10-82267019

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026