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

Rupture of Anterior Cruciate Ligament Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02754674
• Other study ID #: SMC2013-07-097-001
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2017
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1yr after surgery
Secondary	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.	1yr after surgery
Secondary	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.	2 yr after surgery
Secondary	Instability	The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.	2 yr after surgery
Secondary	Graft Maturity (SNQ)		1 yr after surgery