NCT02834962

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

1 year

First QC Date

July 13, 2016

Last Update Submit

July 14, 2016

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (4)

  • cross-sectional area of the reconstructed ACL

    3-6 weeks

  • long to short axis ratio of the cross-sectional area of the reconstructed ACL

    3-6 weeks

  • long axis of the cross-sectional area of the reconstructed ACL

    3-6 weeks

  • short axis of the cross-sectional area of the reconstructed ACL

    3-6 weeks

Study Arms (2)

single bundle ACLR

EXPERIMENTAL

patients undergo single bundle ACL reconstruction

Procedure: single bundle ACL reconstruction

double bundle ACLR

ACTIVE COMPARATOR

patients undergo double bundle ACL reconstruction

Procedure: double bundle ACL reconstruction

Interventions

single bundle ACL reconstructionPROCEDURE

anterior cruciate ligament reconstruction using single bundle technique

single bundle ACLR
double bundle ACL reconstructionPROCEDURE

anterior cruciate ligament reconstruction using double bundle technique

double bundle ACLR

Eligibility Criteria

Age10 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ACL rupture patients aged between 10 to 50 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Jia-Kuo Yu

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Yu Jia-Kuo, MD

CONTACT

86-10-82267392yujiakuo@126.com

Liu Yang, MD

CONTACT

86-10-82267019surgeonliuyang@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2017

Study Completion

August 1, 2017

Last Updated

July 18, 2016

Record last verified: 2016-07