骨腱を使用した前十字靭帯 (ACL) の再建 骨の自家移植片を使用した場合と内部ブレースを使用しない場合の比較
骨腱骨 (BTB) 自家移植片を使用した ACL 再建と内部装具を使用しない場合の比較 - 臨床的および放射線学的結果
There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.
調査の概要
状態
条件
詳細な説明
Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- patients 12 and older
- patients seen by the Columbia University Sports Medicine Service
- patients diagnosed with a first time ACL injury by clinical exam and MRI
Exclusion Criteria:
- previous knee surgery
- concurrent knee fracture or ligamentous injury on ipsilateral knee
- neuromuscular disorder involving lower limb
- inability/ unwillingness to adhere to protocol
- anesthesia contraindications
- lost to follow up
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：ACL reconstruction with internal brace augmentation (suture tape)
This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure. |
The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it. Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy |
|
アクティブコンパレータ：ACL reconstruction without internal brace augmentation
This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure. |
Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Time to Return to Full Activity or Sports
時間枠：Measured once per participant, depending on the time required to return to full activity (up to 10 years)
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Time from treatment initiation to full return to pre-injury activity levels in each group, expressed in weeks |
Measured once per participant, depending on the time required to return to full activity (up to 10 years)
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Percentage of Participants with Recurrent Knee Instability
時間枠：2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
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Percentage of participants that experience recurrent instability after treatment starts at each time point |
2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
|
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Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks
時間枠：Baseline and 2 weeks
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 weeks
|
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Change in PROMIS PF CAT at 6 weeks
時間枠：Baseline and 6 weeks
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A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 weeks
|
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Change in PROMIS PF CAT at 3 months
時間枠：Baseline and 3 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 3 months
|
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Change in PROMIS PF CAT at 6 months
時間枠：Baseline and 6 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 months
|
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Change in PROMIS PF CAT at 1 year
時間枠：Baseline and 1 year
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 1 year
|
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Change in PROMIS PF CAT at 2 years
時間枠：Baseline and 2 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 years
|
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Change in PROMIS PF CAT at 5 years
時間枠：Baseline and 5 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 5 years
|
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Change in PROMIS PF CAT at 10 years
時間枠：Baseline and 10 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's physical functional capacity has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 10 years
|
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Change in PROMIS Pain Interference (PI) CAT at 2 weeks
時間枠：Baseline and 2 weeks
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 weeks
|
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Change in PROMIS PI CAT at 6 weeks
時間枠：Baseline and 6 weeks
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 weeks
|
|
Change in PROMIS PI CAT at 3 months
時間枠：Baseline and 3 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 3 months
|
|
Change in PROMIS PI CAT at 6 months
時間枠：Baseline and 6 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 months
|
|
Change in PROMIS PI CAT at 1 year
時間枠：Baseline and 1 year
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 1 year
|
|
Change in PROMIS PI CAT at 2 years
時間枠：Baseline and 2 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 years
|
|
Change in PROMIS PI CAT at 5 years
時間枠：Baseline and 5 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 5 years
|
|
Change in PROMIS PI CAT at 10 years
時間枠：Baseline and 10 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's pain has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 10 years
|
|
Change in PROMIS Depression CAT at 2 weeks
時間枠：Baseline and 2 weeks
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 weeks
|
|
Change in PROMIS Depression CAT at 6 weeks
時間枠：Baseline and 6 weeks
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 weeks
|
|
Change in PROMIS Depression CAT at 3 months
時間枠：Baseline and 3 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 3 months
|
|
Change in PROMIS Depression CAT at 6 months
時間枠：Baseline and 6 months
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 6 months
|
|
Change in PROMIS Depression CAT at 1 year
時間枠：Baseline and 1 year
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 1 year
|
|
Change in PROMIS Depression CAT at 2 years
時間枠：Baseline and 2 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 2 years
|
|
Change in PROMIS Depression CAT at 5 years
時間枠：Baseline and 5 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 5 years
|
|
Change in PROMIS Depression CAT at 10 years
時間枠：Baseline and 10 years
|
A computerized questionnaire ranging from 0 to 100 points that addresses how a participant's quality of life has been impacted by their knee injury. A lower score indicates a better outcome. |
Baseline and 10 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks
時間枠：Baseline and 2 weeks
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 2 weeks
|
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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks
時間枠：Baseline and 6 weeks
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 6 weeks
|
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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months
時間枠：Baseline and 3 months
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 3 months
|
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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months
時間枠：Baseline and 6 months
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 6 months
|
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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year
時間枠：Baseline and 1 year
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 1 year
|
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Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years
時間枠：Baseline and 2 years
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 2 years
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years
時間枠：Baseline and 5 years
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 5 years
|
|
Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years
時間枠：Baseline and 10 years
|
The WOMAC questionnaire has subscores for pain (0-20), stiffness (0-8), and physical function (0-68), which address the impact of an injury on a participant's life. A lower total score (sum of subscores) indicates a better outcome. |
Baseline and 10 years
|
|
Change in International Knee Documentation Committee (IKDC) Score at 2 weeks
時間枠：Baseline and 2 weeks
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 2 weeks
|
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Change in International Knee Documentation Committee (IKDC) Score at 6 weeks
時間枠：Baseline and 6 weeks
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 6 weeks
|
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Change in International Knee Documentation Committee (IKDC) Score at 3 months
時間枠：Baseline and 3 months
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 3 months
|
|
Change in International Knee Documentation Committee (IKDC) Score at 6 months
時間枠：Baseline and 6 months
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 6 months
|
|
Change in International Knee Documentation Committee (IKDC) Score at 1 year
時間枠：Baseline and 1 year
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 1 year
|
|
Change in International Knee Documentation Committee (IKDC) Score at 2 years
時間枠：Baseline and 2 years
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 2 years
|
|
Change in International Knee Documentation Committee (IKDC) Score at 5 years
時間枠：Baseline and 5 years
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 5 years
|
|
Change in International Knee Documentation Committee (IKDC) Score at 10 years
時間枠：Baseline and 10 years
|
The IKDC questionnaire is scored from 0 (worse outcome)-100 (better outcome) and addresses knee symptoms, function, and physical activity. |
Baseline and 10 years
|
|
Change in numeric pain rating scale (NPRS) Score at 2 weeks
時間枠：Baseline and 2 weeks
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The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 2 weeks
|
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Change in numeric pain rating scale (NPRS) Score at 6 weeks
時間枠：Baseline and 6 weeks
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 6 weeks
|
|
Change in numeric pain rating scale (NPRS) Score at 3 months
時間枠：Baseline and 3 months
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 3 months
|
|
Change in numeric pain rating scale (NPRS) Score at 6 months
時間枠：Baseline and 6 months
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 6 months
|
|
Change in numeric pain rating scale (NPRS) Score at 1 year
時間枠：Baseline and 1 year
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 1 year
|
|
Change in numeric pain rating scale (NPRS) Score at 2 years
時間枠：Baseline and 2 years
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 2 years
|
|
Change in numeric pain rating scale (NPRS) Score at 5 years
時間枠：Baseline and 5 years
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 5 years
|
|
Change in numeric pain rating scale (NPRS) Score at 10 years
時間枠：Baseline and 10 years
|
The NPRS is a questionnaire on a visual analog scale of 0 to 10 that a participant rates based on how bad their pain is (0 = no pain; 10 = maximum pain) |
Baseline and 10 years
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 weeks
時間枠：Baseline and 2 weeks
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 2 weeks
|
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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
時間枠：Baseline and 6 weeks
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 6 weeks
|
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Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3 months
時間枠：Baseline and 3 months
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 3 months
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 months
時間枠：Baseline and 6 months
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 6 months
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 1 year
時間枠：Baseline and 1 year
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 1 year
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 years
時間枠：Baseline and 2 years
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 2 years
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 5 years
時間枠：Baseline and 5 years
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 5 years
|
|
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 10 years
時間枠：Baseline and 10 years
|
The KOOS score is a questionnaire regarding the severity of participants' knee symptoms, which is scored from 0 to 100 (100 representing no severity; 0 representing maximum severity ) |
Baseline and 10 years
|
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Change in Tegner activity scale (TAS) Score at 2 weeks
時間枠：Baseline and 2 weeks
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 2 weeks
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Change in Tegner activity scale (TAS) Score at 6 weeks
時間枠：Baseline and 6 weeks
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 6 weeks
|
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Change in Tegner activity scale (TAS) Score at 3 months
時間枠：Baseline and 3 months
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 3 months
|
|
Change in Tegner activity scale (TAS) Score at 6 months
時間枠：Baseline and 6 months
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 6 months
|
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Change in Tegner activity scale (TAS) Score at 1 year
時間枠：Baseline and 1 year
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 1 year
|
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Change in Tegner activity scale (TAS) Score at 2 years
時間枠：Baseline and 2 years
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 2 years
|
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Change in Tegner activity scale (TAS) Score at 5 years
時間枠：Baseline and 5 years
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 5 years
|
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Change in Tegner activity scale (TAS) Score at 10 years
時間枠：Baseline and 10 years
|
TAS is a one-item questionnaire assessing the activity level of patients on a scale of 0-10, with 0 representing disability and 10 representing the level of a professional athlete. |
Baseline and 10 years
|
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Change in Lysholm Score at 2 weeks
時間枠：Baseline and 2 weeks
|
Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 2 weeks
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Change in Lysholm Score at 6 weeks
時間枠：Baseline and 6 weeks
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Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 6 weeks
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Change in Lysholm Score at 3 months
時間枠：Baseline and 3 months
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Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 3 months
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Change in Lysholm Score at 6 months
時間枠：Baseline and 6 months
|
Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 6 months
|
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Change in Lysholm Score at 1 year
時間枠：Baseline and 1 year
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Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 1 year
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Change in Lysholm Score at 2 years
時間枠：Baseline and 2 years
|
Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 2 years
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Change in Lysholm Score at 5 years
時間枠：Baseline and 5 years
|
Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 5 years
|
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Change in Lysholm Score at 10 years
時間枠：Baseline and 10 years
|
Lysholm score is a questionnaire out of 100 points that addresses specific aspects of participant's knee symptoms, with 100 indicating little to no symptoms and 0 indicating severe symptoms. |
Baseline and 10 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：David P Trofa, MD、Associate Professor of Orthopaedic Surgery
出版物と役立つリンク
一般刊行物
- Engebretsen L, Benum P, Fasting O, Molster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. doi: 10.1177/036354659001800605.
- Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1.
- Cohen SB, Yucha DT, Ciccotti MC, Goldstein DT, Ciccotti MA, Ciccotti MG. Factors affecting patient selection of graft type in anterior cruciate ligament reconstruction. Arthroscopy. 2009 Sep;25(9):1006-10. doi: 10.1016/j.arthro.2009.02.010.
- Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available.
- Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1.
- Bodendorfer BM, Michaelson EM, Shu HT, Apseloff NA, Spratt JD, Nolton EC, Argintar EH. Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis. Arthroscopy. 2019 Jul;35(7):2114-2122. doi: 10.1016/j.arthro.2019.01.054. Epub 2019 Jun 2.
- Parkes CW, Leland DP, Levy BA, Stuart MJ, Camp CL, Saris DBF, Krych AJ. Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-Inside Technique With and Without Independent Suture Tape Reinforcement. Arthroscopy. 2021 Feb;37(2):609-616. doi: 10.1016/j.arthro.2020.09.002. Epub 2020 Nov 2.
- Batty LM, Norsworthy CJ, Lash NJ, Wasiak J, Richmond AK, Feller JA. Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review. Arthroscopy. 2015 May;31(5):957-68. doi: 10.1016/j.arthro.2014.11.032. Epub 2015 Jan 22.
- Smith PA, Bley JA. Allograft Anterior Cruciate Ligament Reconstruction Utilizing Internal Brace Augmentation. Arthrosc Tech. 2016 Oct 10;5(5):e1143-e1147. doi: 10.1016/j.eats.2016.06.007. eCollection 2016 Oct.
- E A Mackenzie C, Huntington LS, Tulloch S. Suture Tape Augmentation of Anterior Cruciate Ligament Reconstruction Increases Biomechanical Stability: A Scoping Review of Biomechanical, Animal, and Clinical Studies. Arthroscopy. 2022 Jun;38(6):2073-2089. doi: 10.1016/j.arthro.2021.12.036. Epub 2022 Jan 3.
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