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

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
type of anterior cruciate ligament reconstruction
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transportal

Outside in

Arm Description

this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique

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

Outcomes

Primary Outcome Measures

Vascularity of Graft Tendon
For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.

Secondary Outcome Measures

Arthroscopy Grading
Graft continuity was graded as no tears, superficial tear (fibrillation or tear of superficial fibers), or substantial tear (rupture of 1 or more strands). Graft tension was graded as taut, mild lax, and lax by probing at knee flexion and extension. Synovial coverage of the grafts was graded as excellent (synovial coverage > 80% around graft), fair (coverage > 50%), or poor (coverage < 50%) On the second-look arthroscopic examination, graft continuity, graft tension, graft synovialization, and the presence of cyclops lesions were assessed by a senior surgeon.
Clinical Knee Scoring
Lysholm score (ragne 0-100), HSS (hospital for special surgery) score (0-100) , IKDC (international knee doucomentation commitee) subjective score (0-100), Tegner activity scale (0-10). All of scores demonstrated that higher score means a better outcomes.
Instability
The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.
Graft Maturity (SNQ)

Full Information

First Posted
February 22, 2015
Last Updated
December 3, 2019
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02754674
Brief Title
Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. 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
Detailed Description
Anterior cruciate ligament (ACL) injury patients : Total 66 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transportal
Arm Type
Experimental
Arm Description
this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique
Arm Title
Outside in
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
type of anterior cruciate ligament reconstruction
Intervention Description
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 Outcome Measure Information:
Title
Vascularity of Graft Tendon
Description
For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.
Time Frame
1yr after surgery
Secondary Outcome Measure Information:
Title
Arthroscopy Grading
Description
Graft continuity was graded as no tears, superficial tear (fibrillation or tear of superficial fibers), or substantial tear (rupture of 1 or more strands). Graft tension was graded as taut, mild lax, and lax by probing at knee flexion and extension. Synovial coverage of the grafts was graded as excellent (synovial coverage > 80% around graft), fair (coverage > 50%), or poor (coverage < 50%) On the second-look arthroscopic examination, graft continuity, graft tension, graft synovialization, and the presence of cyclops lesions were assessed by a senior surgeon.
Time Frame
1yr after surgery
Title
Clinical Knee Scoring
Description
Lysholm score (ragne 0-100), HSS (hospital for special surgery) score (0-100) , IKDC (international knee doucomentation commitee) subjective score (0-100), Tegner activity scale (0-10). All of scores demonstrated that higher score means a better outcomes.
Time Frame
2 yr after surgery
Title
Instability
Description
The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.
Time Frame
2 yr after surgery
Title
Graft Maturity (SNQ)
Time Frame
1 yr after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Ho Wang, MD, Ph D
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
if yes, age, sex, physical examination, trauma date, MRI.
Citations:
PubMed Identifier
28915914
Citation
Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.
Results Reference
derived

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

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