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治験 NCT07318272（対象：Anterior Cruciate Ligament (ACL) Tear、前十字靭帯再建術、Isokinetic Test）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ガーズィ大学Clinical and Functional Outcomes After ACL Reconstruction Versus Primary Repair 45 翻訳あり
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07318272 は 観察研究 臨床試験 で、Anterior Cruciate Ligament (ACL) Tear、前十字靭帯再建術、Isokinetic Test に関するものです。現在は 募集準備中 で、2026年1月1日 に開始予定です。45 名の参加者 の募集が計画されています。この試験は ガーズィ大学 によって主導され、2027年8月30日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月5日 です。
概要
The anterior cruciate ligament (ACL) is the primary structure responsible for controlling anterior-posterior translation and rotational stability of the knee joint. Although ACL reconstruction has long been considered the gold standard among surgical interventions following ACL injury, arthroscopic primary repair techniques have recently regained interest. With advances in minimally invasive surgical procedures, refi...もっと見る
詳細説明
The anterior cruciate ligament (ACL), one of the key stabilizers of the knee joint, plays a crucial role in maintaining both anteroposterior and rotational stability. The increasing popularity of recreational and competitive sports has contributed to a rising incidence of ACL injuries in recent years. Until the late 1980s, primary repair was widely accepted as the standard treatment for ACL injuries. Although short-t...もっと見る
公式タイトル
Comparison of Clinical and Functional Outcomes After Anterior Cruciate Ligament Reconstruction and Primary Repair Surgery
疾患名
Anterior Cruciate Ligament (ACL) Tear前十字靭帯再建術Isokinetic Test刊行物
この臨床試験について発表された科学記事と研究論文：その他の研究識別子
- Gazi2025
NCT番号
開始日
2026-01-01
最終更新日
2026-01-05
終了予定日
2027-08-30
目標参加者数
45
試験の種類
観察研究
状況
募集準備中
キーワード
ACL Injury
Anterior Cruciate Ligament
ACL Reconstruction
ACL Primary Repair
Postoperative Outcomes
Muscle Oxygenation
Isokinetic Testing
Anterior Cruciate Ligament
ACL Reconstruction
ACL Primary Repair
Postoperative Outcomes
Muscle Oxygenation
Isokinetic Testing
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
ACL Reconstruction Group Demographic data, injury history, and surgical details will be recorded for all participants. The International Physical Activity Questionnaire, IKDC, and ACL-RSI scales will be administered. Assessments will be completed over two days. Isokinetic knee flexor/extensor strength, fatigue protocol, and H/Q ratios will be measured using the Cybex Norm dynamometer. Quadriceps and hamstring muscle oxygenation will be asses...もっと見る | 該当なし |
Primary ACL Repair Group Demographic data, injury history, and surgical details will be recorded for all participants. The International Physical Activity Questionnaire, IKDC, and ACL-RSI scales will be administered. Assessments will be completed over two days. Isokinetic knee flexor/extensor strength, fatigue protocol, and H/Q ratios will be measured using the Cybex Norm dynamometer. Quadriceps and hamstring muscle oxygenation will be asses...もっと見る | 該当なし |
Healthy Control Group Demographic data and physical activity levels will be recorded for healthy participants. All individuals will complete the International Physical Activity Questionnaire, IKDC, and ACL-RSI scales. Assessments will be conducted over two days. Knee flexor/extensor strength and H/Q ratios will be measured using the Cybex Norm isokinetic dynamometer. Quadriceps and hamstring muscle oxygenation will be assessed with the Tr...もっと見る | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Peak Torque (Isokinetic Strength) | Peak torque of the knee flexor and extensor muscles will be measured using an isokinetic dynamometer (Cybex NORM® isokinetic dynamometer, Humac, CA, USA). Measurements will be performed in the following modes: concentric contraction at 60°/s, eccentric contraction at 60°/s, concentric contraction at 180°/s, and concentric contraction at 300°/s. Peak torque values will be recorded for each testing velocity and contraction mode and expressed in Newton-meters (Nm).
Unit of Measure: Newton-meter (Nm) | First Day |
Extremity Symmetry Index (ESI) | Extremity Symmetry Index will be calculated by comparing the involved and uninvolved limbs using peak torque values obtained from isokinetic testing.
Unit of Measure: Percentage (%) | First day |
Conventional Hamstring-to-Quadriceps Ratio (H/Q Ratio) | The conventional H/Q ratio will be calculated as the ratio of concentric hamstring peak torque to concentric quadriceps peak torque. Unit of Measure: Ratio | First day |
Functional Hamstring-to-Quadriceps Ratio | The functional H/Q ratio will be calculated as the ratio of eccentric hamstring peak torque to concentric quadriceps peak torque. Unit of Measure: Ratio | First day |
Functional Range | Functional range will be defined as the angular range in which at least 85% of peak torque is maintained during isokinetic testing. Unit of Measure: Percentage (%) | First Day |
Fatigue-Induced Peak Torque Decline | Fatigue-related performance decline will be calculated as the percentage decrease in peak torque following a 33-repetition isokinetic fatigue protocol at 300°/s. Unit of Measure: Percentage (%) | First Day |
Muscle Oxygenation | Muscle oxygenation will be assessed using the Train.Red FYER wireless near-infrared spectroscopy (NIRS) system (Train.Red, Gelderland, Netherlands). The device provides continuous, non-invasive measurements of tissue oxygen saturation (StO₂) and the oxy-deoxyhemoglobin difference (HbDiff). Sensors will be placed over the quadriceps and hamstring muscles following SENIAM guidelines. Muscle oxygenation will be recorded before and immediately after the isokinetic fatigue protocol to evaluate changes in local oxygen utilization and metabolic stress. | First Day |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Knee Joint Proprioception | Knee proprioception will be assessed using an active joint repositioning test performed on the Cybex NORM® isokinetic system (Humac, CA, USA). Participants will actively reproduce a target angle (30° knee flexion) starting from 90° flexion. Three trials will be recorded, and the absolute angular error will be calculated as the mean difference between the target angle and the reproduced angles. This measure reflects the accuracy of joint position sense and will be used to evaluate proprioceptive function. | First Day |
Single Leg Balance | Postural control will be assessed using the KFORCE Plates force platform (Kinvent, Montpellier, France). Participants will perform a single-leg balance task, and Center of Pressure (CoP)-based variables such as mean CoP velocity, path length, sway area, and stabilization time will be recorded. Measurements will be obtained under standardized testing conditions for both limbs. | Second Day |
Single Leg Landing | Dynamic stability will be assessed using the KFORCE Plates force platform. Participants will perform a single-leg landing task, and Center of Pressure (CoP)-based variables including stabilization time, CoP displacement, sway area, and CoP velocity will be analyzed. This measure evaluates the participant's ability to achieve stable posture following landing. | Second Day |
Knee Laxity | Knee anterior laxity will be assessed using the GNRB® arthrometer at 20° of knee flexion. The primary outcome variable will be Anterior Tibial Translation (ATT) measured in millimeters under standardized forces (134 N and 200 N). The side-to-side difference in ATT and the slope value (stiffness index) will also be recorded to evaluate anterior cruciate ligament integrity. These parameters provide an objective and quantitative measure of ligamentous stability. | First Day |
IKDC Subjective Knee Evaluation | The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form will be used to assess patient-reported knee symptoms, function, and sports activity levels. Scores range from 0 to 100, with higher scores indicating better knee function and fewer symptoms. This measure provides a validated assessment of functional recovery following ACL surgery. | First Day |
ACL-RSI (Return to Sport Index) | The Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) scale will be administered to evaluate psychological readiness to return to sport. The 12-item scale assesses emotions, confidence, and risk appraisal related to returning to physical activity. Scores range from 0 to 100, with higher scores indicating greater psychological readiness. This measure allows comparison of psychological recovery after ACL reconstruction and primary repair. | First Day |
参加アシスタント
適格基準
対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
- Age 18-40 years
- History of complete ACL rupture treated with ACL reconstruction
- Surgery performed at Gazi University Department of Orthopedics and Traumatology
- At least 12 months postoperative at the time of evaluation
- Ability to comply with all study procedures
- Signed informed consent
- Previous surgery for partial or chronic ACL tear
- Concomitant multi-ligament knee injuries
- Prior surgery on the ipsilateral or contralateral knee
- Lower extremity malalignment (e.g., significant varus/valgus)
- Tibial avulsion-type ACL injury
- Neurological or musculoskeletal disorders affecting lower limb function
- Any medical condition that may interfere with test performance or safety
Inclusion Criteria for the Primary ACL Repair Group
- Age 18-40 years
- Complete ACL rupture treated with arthroscopic primary ACL repair
- Surgery performed at Gazi University Department of Orthopedics and Traumatology
- Minimum 12 months postoperative at the time of assessment A-bility to follow and complete study procedures
- Signed informed consent
Exclusion Criteria for the Primary ACL Repair Group
- Previous surgery for partial or chronic ACL injury
- Multi-ligament knee injuries
- History of surgery on either knee
- Lower extremity malalignment
- Tibial avulsion-type ACL rupture
- Neuromuscular or musculoskeletal diseases affecting lower limb function or balance
- Any condition that may affect participation or compromise safety
Inclusion Criteria for the Healthy Control Group
- Age 18-40 years
- No significant lower-extremity malalignment (e.g., varus/valgus deformity)
- No history of lower-extremity injury within the past 12 months
- No known chronic systemic disease
- No history of knee surgery or diagnosed knee pathology
- Ability to understand and comply with study procedures
- Signed informed consent
Exclusion Criteria for the Healthy Control Group
- Presence of clinically significant lower-extremity malalignment
- Lower-extremity musculoskeletal injury within the last 12 months
- Any chronic systemic or metabolic disease
- History of knee injury, knee surgery, or diagnosed knee pathology
- Neurological, vestibular, or musculoskeletal disorder affecting balance or gait
- Inability to complete study procedures
ガーズィ大学責任者
Dudu Özdemir, 主任研究者, MSc., Gazi University
試験中央連絡先
連絡先: Dudu Ozdemir Can, Msc, 90 5534448492, [email protected]
1 1カ国の場所
Çankaya
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Ankara, Çankaya, 06490, Turkey (Türkiye)
Dudu Ozdemir Can, MSc, 連絡先, 90 5534448492, [email protected]