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.
1 other identifier
interventional
320
0 countries
N/A
Brief Summary
The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 11, 2016
CompletedFirst Posted
Study publicly available on registry
July 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 15, 2016
July 1, 2016
2 years
July 11, 2016
July 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Lysholm score of the knee
Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
two years
Tegner score of the knee
Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
two years
IKDC score of the knee
IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
two years
Secondary Outcomes (1)
KT-2000 of the knee
two years
Study Arms (4)
direct insertion single bundle ACLR
ACTIVE COMPARATORPatients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.
anatomical double bundle ACLR
EXPERIMENTALPatients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.
anatomical single bundle ACLR
EXPERIMENTALPatients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.
direct insertion double bundle ACLR
ACTIVE COMPARATORPatients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
Interventions
ACL reconstruction based on direct insertion of ACL.
anterior cruciate ligament reconstruction using single bundle technique
anterior cruciate ligament reconstruction using double bundle technique
Eligibility Criteria
You may qualify if:
- ACL rupture patients aged between 16 to 40 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 infammatory 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
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jia-Kuo Yu, MD
Peking University Third Hospital
Central Study Contacts
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 11, 2016
First Posted
July 14, 2016
Study Start
July 1, 2016
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
July 15, 2016
Record last verified: 2016-07