Trial Outcomes & Findings for Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques (NCT NCT02754674)
NCT ID: NCT02754674
Last Updated: 2019-12-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
1yr after surgery
Results posted on
2019-12-20
Participant Flow
Participant milestones
| Measure |
Transportal
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.
|
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
28
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Transportal
n=34 Participants
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
|
Outside in
n=33 Participants
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
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=67 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=34 Participants
|
33 Participants
n=33 Participants
|
67 Participants
n=67 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=34 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=67 Participants
|
|
Age, Continuous
|
29.5 year
STANDARD_DEVIATION 8 • n=34 Participants
|
33.5 year
STANDARD_DEVIATION 9.3 • n=33 Participants
|
31.4 year
STANDARD_DEVIATION 8.8 • n=67 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=34 Participants
|
6 Participants
n=33 Participants
|
12 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=34 Participants
|
27 Participants
n=33 Participants
|
55 Participants
n=67 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
34 participants
n=34 Participants
|
33 participants
n=33 Participants
|
67 participants
n=67 Participants
|
|
Time from injury to ACLR
|
1.4 month
STANDARD_DEVIATION 1.6 • n=34 Participants
|
1.5 month
STANDARD_DEVIATION 1.7 • n=33 Participants
|
1.4 month
STANDARD_DEVIATION 1.6 • n=67 Participants
|
|
Auto-Graft
|
8 Participants
n=34 Participants
|
10 Participants
n=33 Participants
|
18 Participants
n=67 Participants
|
|
BMI
|
25.8 kg/m2
STANDARD_DEVIATION 4 • n=34 Participants
|
25.1 kg/m2
STANDARD_DEVIATION 2.9 • n=33 Participants
|
25.5 kg/m2
STANDARD_DEVIATION 3.5 • n=67 Participants
|
PRIMARY outcome
Timeframe: 1yr after surgeryFor 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.
Outcome measures
| Measure |
Transportal
n=28 Participants
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.
|
Outside in
n=26 Participants
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.
|
|---|---|---|
|
Vascularity of Graft Tendon
|
2.5 ratio of AUC
Standard Deviation 2.0
|
4.1 ratio of AUC
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 1yr after surgeryGraft 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.
Outcome measures
| Measure |
Transportal
n=21 Participants
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.
|
Outside in
n=20 Participants
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.
|
|---|---|---|
|
Arthroscopy Grading
synovialization · Excellent
|
6 Participants
|
11 Participants
|
|
Arthroscopy Grading
synovialization · Fair
|
9 Participants
|
7 Participants
|
|
Arthroscopy Grading
synovialization · Poor
|
6 Participants
|
2 Participants
|
|
Arthroscopy Grading
continuity · Excellent
|
15 Participants
|
11 Participants
|
|
Arthroscopy Grading
continuity · Fair
|
3 Participants
|
8 Participants
|
|
Arthroscopy Grading
continuity · Poor
|
3 Participants
|
1 Participants
|
|
Arthroscopy Grading
tension · Excellent
|
17 Participants
|
18 Participants
|
|
Arthroscopy Grading
tension · Fair
|
3 Participants
|
1 Participants
|
|
Arthroscopy Grading
tension · Poor
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 yr after surgeryLysholm 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.
Outcome measures
| Measure |
Transportal
n=28 Participants
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.
|
Outside in
n=26 Participants
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.
|
|---|---|---|
|
Clinical Knee Scoring
Lysholm score
|
89.1 score
Standard Deviation 8.4
|
90.1 score
Standard Deviation 9.1
|
|
Clinical Knee Scoring
HSS score
|
97.4 score
Standard Deviation 4.0
|
98.7 score
Standard Deviation 3.3
|
|
Clinical Knee Scoring
IDKC score
|
83.6 score
Standard Deviation 9.7
|
87.9 score
Standard Deviation 7.7
|
|
Clinical Knee Scoring
tegner
|
6 score
Standard Deviation 2
|
6 score
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 2 yr after surgeryThe side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.
Outcome measures
| Measure |
Transportal
n=28 Participants
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.
|
Outside in
n=26 Participants
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.
|
|---|---|---|
|
Instability
|
2.6 mm
Standard Deviation 1.3
|
1.9 mm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 1 yr after surgeryOutcome measures
| Measure |
Transportal
n=28 Participants
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.
|
Outside in
n=26 Participants
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.
|
|---|---|---|
|
Graft Maturity (SNQ)
|
69.4 SNQ
Standard Deviation 34.7
|
53.1 SNQ
Standard Deviation 24.5
|
Adverse Events
Transportal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Outside in
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Transportal
n=28 participants at risk
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.
|
Outside in
n=26 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
infection
|
0.00%
0/28 • between 6months and 1 year
|
0.00%
0/26 • between 6months and 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place