Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02834962
• Other study ID #: ACLMRI-1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 14, 2016
• Start date: July 2016
• Est. completion date: August 2017

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

To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.

Description:

The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 50 Years

Eligibility

Inclusion Criteria:

• ACL rupture patients aged between 10 to 50 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 inflammatory 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:
• single bundle ACL reconstruction
anterior cruciate ligament reconstruction using single bundle technique
• double bundle ACL 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	cross-sectional area of the reconstructed ACL		3-6 weeks	No
Primary	long to short axis ratio of the cross-sectional area of the reconstructed ACL		3-6 weeks	No
Primary	long axis of the cross-sectional area of the reconstructed ACL		3-6 weeks	No
Primary	short axis of the cross-sectional area of the reconstructed ACL		3-6 weeks	No