Overview

This trial is active, not recruiting.

Condition rupture of anterior cruciate ligament
Treatment type of anterior cruciate ligament reconstruction
Sponsor Samsung Medical Center
Start date May 2014
End date May 2014
Trial size 66 participants
Trial identifier NCT02754674, SMC2013-07-097-001

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique
type of anterior cruciate ligament reconstruction
comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation
(Experimental)
this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique
type of anterior cruciate ligament reconstruction
comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation

Primary Outcomes

Measure
Geometrical changes of the femoral and tibial tunnel
time frame: 1yr and 2 yr after surgery

Secondary Outcomes

Measure
Arthroscopy grading
time frame: 1yr after surgery
Clinical knee scoring
time frame: 1yr and 2 yr after surgery
Comparison of tunnel formation such as tunnel position between conventional CT (segmentation technique) and MRI segmentation
time frame: 1yr and 2 yr after surgery
Comparison of contralateral MRI (using mirror image technique) and Assessment of normal anatomical reconstruction
time frame: 1yr and 2 yr after surgery
Geometrical change of graft tendon
time frame: 1yr and 2 yr after surgery
Healing of graft tendon
time frame: 1yr and 2 yr after surgery

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

Inclusion Criteria: 1. Lachman test grade II,III and Pivot shift test grade II,III in physical examination 2. ACL rupture in MRI 3. Age 20~60 4. within 6 months after trauma Exclusion Criteria: 1. osteoarthritis (OA) change in X-ray 2. History of other ligament injury or ACL reconstruction in uninjured knee. 3. operation history of either ipsilateral or contralateral knee(fracture, etc)

Additional Information

Official title Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial
Description Anterior cruciate ligament (ACL) injury patients : Total 66 1. Double bundle transportal technique with flexible reamer: 33 - Advantage: more normal ACL reconstruction than single bundle technique - Disadvantage: to make the two bone tunnel must remove all the residual tissue. 2. Single bundle outside in technique with remnant preservation: 33 - Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery. - Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Samsung Medical Center.