Rupture of Anterior Cruciate Ligament
Conditions
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
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. 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.
Interventions
PROCEDUREtype 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
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| Graft Maturity (SNQ) | 1 yr after surgery | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 33 |
| Total | 67 |
Baseline characteristics
| Characteristic | Transportal | Outside in | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 34 Participants | 33 Participants | 67 Participants |
| Age, Continuous | 29.5 year STANDARD_DEVIATION 8 | 33.5 year STANDARD_DEVIATION 9.3 | 31.4 year STANDARD_DEVIATION 8.8 |
| Auto-Graft | 8 Participants | 10 Participants | 18 Participants |
| BMI | 25.8 kg/m2 STANDARD_DEVIATION 4 | 25.1 kg/m2 STANDARD_DEVIATION 2.9 | 25.5 kg/m2 STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment South Korea | 34 participants | 33 participants | 67 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 28 Participants | 27 Participants | 55 Participants |
| Time from injury to ACLR | 1.4 month STANDARD_DEVIATION 1.6 | 1.5 month STANDARD_DEVIATION 1.7 | 1.4 month STANDARD_DEVIATION 1.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 26 |
| other Total, other adverse events | 0 / 28 | 0 / 26 |
| serious Total, serious adverse events | 0 / 28 | 0 / 26 |
Outcome results
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.
Time frame: 1yr after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transportal | Vascularity of Graft Tendon | 2.5 ratio of AUC | Standard Deviation 2 |
| Outside in | Vascularity of Graft Tendon | 4.1 ratio of AUC | Standard Deviation 2.5 |
p-value: 0.008t-test, 2 sided
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.
Time frame: 1yr after surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Transportal | Arthroscopy Grading | synovialization | Fair | 9 Participants |
| Transportal | Arthroscopy Grading | continuity | Poor | 3 Participants |
| Transportal | Arthroscopy Grading | continuity | Excellent | 15 Participants |
| Transportal | Arthroscopy Grading | tension | Excellent | 17 Participants |
| Transportal | Arthroscopy Grading | synovialization | Poor | 6 Participants |
| Transportal | Arthroscopy Grading | tension | Fair | 3 Participants |
| Transportal | Arthroscopy Grading | continuity | Fair | 3 Participants |
| Transportal | Arthroscopy Grading | tension | Poor | 1 Participants |
| Transportal | Arthroscopy Grading | synovialization | Excellent | 6 Participants |
| Outside in | Arthroscopy Grading | tension | Poor | 1 Participants |
| Outside in | Arthroscopy Grading | synovialization | Excellent | 11 Participants |
| Outside in | Arthroscopy Grading | synovialization | Fair | 7 Participants |
| Outside in | Arthroscopy Grading | synovialization | Poor | 2 Participants |
| Outside in | Arthroscopy Grading | continuity | Excellent | 11 Participants |
| Outside in | Arthroscopy Grading | continuity | Fair | 8 Participants |
| Outside in | Arthroscopy Grading | continuity | Poor | 1 Participants |
| Outside in | Arthroscopy Grading | tension | Excellent | 18 Participants |
| Outside in | Arthroscopy Grading | tension | Fair | 1 Participants |
p-value: >0.05Chi-squared
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.
Time frame: 2 yr after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Transportal | Clinical Knee Scoring | Lysholm score | 89.1 score | Standard Deviation 8.4 |
| Transportal | Clinical Knee Scoring | IDKC score | 83.6 score | Standard Deviation 9.7 |
| Transportal | Clinical Knee Scoring | HSS score | 97.4 score | Standard Deviation 4 |
| Transportal | Clinical Knee Scoring | tegner | 6 score | Standard Deviation 2 |
| Outside in | Clinical Knee Scoring | tegner | 6 score | Standard Deviation 2 |
| Outside in | Clinical Knee Scoring | Lysholm score | 90.1 score | Standard Deviation 9.1 |
| Outside in | Clinical Knee Scoring | HSS score | 98.7 score | Standard Deviation 3.3 |
| Outside in | Clinical Knee Scoring | IDKC score | 87.9 score | Standard Deviation 7.7 |
Comparison: 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.p-value: >0.05t-test, 2 sided
Secondary
Graft Maturity (SNQ)
Time frame: 1 yr after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transportal | Graft Maturity (SNQ) | 69.4 SNQ | Standard Deviation 34.7 |
| Outside in | Graft Maturity (SNQ) | 53.1 SNQ | Standard Deviation 24.5 |
p-value: 0.054t-test, 2 sided
Secondary
Instability
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transportal | Instability | 2.6 mm | Standard Deviation 1.3 |
| Outside in | Instability | 1.9 mm | Standard Deviation 1 |
p-value: >0.05t-test, 2 sided