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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
Anterior cruciate ligament (ACL) injury patients : Total 66
Double bundle transportal technique with flexible reamer: 33
Single bundle outside in technique with remnant preservation: 33
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transportal | Experimental | this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique |
|
| Outside in | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| type of anterior cruciate ligament reconstruction | Procedure | 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 | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joon Ho Wang, MD, Ph D | Samsung Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28915914 | Derived | 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. |
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if yes, age, sex, physical examination, trauma date, MRI.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | ratio of AUC | 1yr after surgery |
|
between 6months and 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | surgical site infection |
Technical problems with measurement leading to unreliable or uninterpretable data
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Wang, JoonHo | Samsung Medical Center | 82-2-3410-3507 | mdwang88@gmail.com |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| 1yr after surgery |
| 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 |
| 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 |
| Graft Maturity (SNQ) | 1 yr after surgery |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time from injury to ACLR | Mean | Standard Deviation | month |
|
| Auto-Graft | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score | 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. | Posted | Mean | Standard Deviation | mm | 2 yr after surgery |
|
|
|
|
| Secondary | Graft Maturity (SNQ) | Posted | Mean | Standard Deviation | SNQ | 1 yr after surgery |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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. | 0 | 26 | 0 | 26 | 0 | 26 |
|
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| Poor |
|
| continuity |
|
| tension |
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| IDKC score |
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| tegner |
|