ACL Tear Clinical Trial
Official title:
ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | September 2032 |
Est. primary completion date | September 2032 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Irving Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Return to Full Activity or Sports | 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) | |
Primary | Percentage of Participants with Recurrent Knee Instability | 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 | |
Primary | Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 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 | |
Primary | Change in PROMIS PF CAT at 6 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 6 weeks | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS PF CAT at 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 | |
Primary | Change in PROMIS Pain Interference (PI) CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS PI CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Primary | Change in PROMIS Depression CAT at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in International Knee Documentation Committee (IKDC) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 2 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 2 weeks | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in numeric pain rating scale (NPRS) Score at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Tegner activity scale (TAS) Score at 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 | |
Secondary | Change in Lysholm Score at 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 | |
Secondary | Change in Lysholm Score at 6 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 6 weeks | |
Secondary | Change in Lysholm Score at 3 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 3 months | |
Secondary | Change in Lysholm Score at 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 | |
Secondary | Change in Lysholm Score at 1 year | 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 | |
Secondary | Change in Lysholm Score at 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 | |
Secondary | Change in Lysholm Score at 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 | |
Secondary | Change in Lysholm Score at 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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