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N/A N=67 Randomized Single-blind Treatment

Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques

Rupture of Anterior Cruciate Ligament

Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Vascularity of Graft Tendon — 2.5; 4.1 ratio of AUC — p=0.008

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
type of anterior cruciate ligament reconstruction (Procedure)
Age
Adult · 20+ yrs
Sex
All
Sponsor
Samsung Medical Center
Primary completion
May 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Vascularity of Graft Tendon
2.5; 4.1 0.008 sig
SECONDARY
Arthroscopy Grading
6; 11; 9; 7; 6; 2 >0.05
SECONDARY
Clinical Knee Scoring
89.1; 90.1; 97.4; 98.7; 83.6; 87.9 >0.05
SECONDARY
Instability
2.6; 1.9 >0.05
SECONDARY
Graft Maturity (SNQ)
69.4; 53.1 0.054

Summary

1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation. 2. Subjects: anterior cruciate ligament (ACL) injury 66 patients * Double bundle transportal technique with flexible reamer: 33 * Single bundle outside in technique with remnant preservation: 33

Eligibility Criteria

Inclusion Criteria

  • Lachman test grade II, III and Pivot shift test grade II,III in physical examination
  • ACL rupture in MRI
  • Age 20~60
  • within 6 months after trauma

Exclusion Criteria

  • osteoarthritis (OA) change in X-ray
  • History of other ligament injury or ACL reconstruction in uninjured knee.
  • operation history of either ipsilateral or contralateral knee(fracture, etc)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02754674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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