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

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02754674
• Collaborator: (none)
• Enrollment: 67
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Rupture of Anterior Cruciate Ligament	Procedure: type of anterior cruciate ligament reconstruction	N/A

Detailed 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.

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transportal this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique	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
Experimental: Outside in 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	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

Outcome Measures

Primary Outcome Measures

1. Vascularity of Graft Tendon [1yr after surgery]

   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

1. Arthroscopy Grading [1yr after surgery]

   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.

2. Clinical Knee Scoring [2 yr after surgery]

   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.

3. Instability [2 yr after surgery]

   The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.

4. Graft Maturity (SNQ) [1 yr after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

• Study Chair: Joon Ho Wang, MD, Ph D, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02754674
• Other Study ID Numbers: SMC2013-07-097-001
• First Posted: Apr 28, 2016
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Rupture

Study Results

Participant Flow

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	34	33
COMPLETED	28	26
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	Transportal	Outside in	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	34	33	67
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	34 100%	33 100%	67 100%
>=65 years	0 0%	0 0%	0 0%
Age (year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [year]	29.5 (8)	33.5 (9.3)	31.4 (8.8)
Sex: Female, Male (Count of Participants)
Female	6 17.6%	6 18.2%	12 17.9%
Male	28 82.4%	27 81.8%	55 82.1%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
South Korea	34 100%	33 100%	67 100%
Time from injury to ACLR (month) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [month]	1.4 (1.6)	1.5 (1.7)	1.4 (1.6)
Auto-Graft (Count of Participants)
Count of Participants [Participants]	8 23.5%	10 30.3%	18 26.9%
BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	25.8 (4)	25.1 (2.9)	25.5 (3.5)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Measure Participants	28	26
Mean (Standard Deviation) [ratio of AUC]	2.5 (2.0)	4.1 (2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transportal, Outside in
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Measure Participants	21	20
Excellent	6 17.6%	11 33.3%
Fair	9 26.5%	7 21.2%
Poor	6 17.6%	2 6.1%
Excellent	15 44.1%	11 33.3%
Fair	3 8.8%	8 24.2%
Poor	3 8.8%	1 3%
Excellent	17 50%	18 54.5%
Fair	3 8.8%	1 3%
Poor	1 2.9%	1 3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transportal, Outside in
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Measure Participants	28	26
Lysholm score	89.1 (8.4)	90.1 (9.1)
HSS score	97.4 (4.0)	98.7 (3.3)
IDKC score	83.6 (9.7)	87.9 (7.7)
tegner	6 (2)	6 (2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transportal, Outside in
	Comments	We used the Kolmogorov-Smirnov test to assess the normality of the data distribution. Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. Pearson's Chi-square test or Fisher's exact test was used to analyze categorical variables between groups. The statistical significance level was set at .05.
	Type of Statistical Test	Superiority
	Comments	Student's t-test or the Mann-Whitney U-test was used to analyze intergroup differences. The paired t-test or Wilcoxon signed rank test was used to analyze differences between pre- and postoperative values. The statistical significance level was set at .05.
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Measure Participants	28	26
Mean (Standard Deviation) [mm]	2.6 (1.3)	1.9 (1.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transportal, Outside in
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Graft Maturity (SNQ)
Time Frame	1 yr after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transportal	Outside in
Arm/Group Description	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.	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.
Measure Participants	28	26
Mean (Standard Deviation) [SNQ]	69.4 (34.7)	53.1 (24.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Transportal, Outside in
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.054
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	between 6months and 1 year
Arm/Group Title	Transportal		Outside in
Arm/Group Description	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.		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.
All Cause Mortality
	Transportal		Outside in
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/26 (0%)
Serious Adverse Events
	Transportal		Outside in
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Transportal		Outside in
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/26 (0%)
Musculoskeletal and connective tissue disorders
infection	0/28 (0%)	0	0/26 (0%)	0

Limitations/Caveats

Technical problems with measurement leading to unreliable or uninterpretable data

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.