Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02833454
• Other study ID #: DACL-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2016
• Last updated: July 13, 2016
• Start date: July 2016
• Est. completion date: August 2018

Study information

• Verified date: July 2016
• Source: Peking University Third Hospital
• Contact: Yu Jia-Kuo, MD
• Phone: 86-10-82267392
• Email: yujiakuo[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• direct insertion anterior cruciate ligament reconstruction
ACL reconstruction based on direct insertion of ACL.
• single bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using single bundle technique
• double bundle anterior cruciate ligament reconstruction
anterior cruciate ligament reconstruction using double bundle technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lysholm score of the knee	Lysholm score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score	two years	No
Primary	Tegner score of the knee	Tegner score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score	two years	No
Primary	IKDC score of the knee	IKDC score of the knee was evaluated preoperatively and at 2 years post operation .; Scale name:score	two years	No
Secondary	KT-2000 of the knee	KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.	two years	No