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ACL Tear clinical trials

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NCT ID: NCT06340932 Not yet recruiting - Post Operative Pain Clinical Trials

Impact of Opioid Avoidance Protocol for ACL Reconstruction

Start date: March 28, 2024
Phase:
Study type: Observational

This is a prospective, quasi-experimental, cohort study comparing patients treated with one of two postoperative pain management protocols. The two protocols assessed will be the current standard of care protocol for ACLR postoperative pain control utilized by Dr. Matthew Varacallo and then an opioid avoidance protocol that is planned to be implemented on the Spring of 2024. The study is voluntary, however all patients will be treated with either of the two protocols depending on their date of surgery. This study will include patients aged 15 years and older who consent to the participation in the study. Patients will be identified utilizing the operative surgeon's appointment calendar and will be screened and offered inclusion in the study if applicable at their pre-operative visit. Data will be collected via patient medication and pain diary, phone call, and clinician administration of standardized outcome questionnaires. Patients will be included in the standard of care group if ACLR is performed prior to the change in protocol in the Spring of 2024 or the opioid avoidance group if performed after the protocol change. The primary objective of this study is to evaluate the effect of the opioid avoidance protocol on opioid use in MME from POD0-7 after ACLR compared to the current standard of care pain management protocol. Secondary objectives are to: - evaluate the effects of an opioid avoidance protocol on the daily average NRS pain scores from POD0-7 - evaluate the effects of an opioid avoidance protocol on the daily worst NRS pain score from POD0-7 - evaluate the ability to recover opioid free through 7, 30, and 60 days - evaluate the QoR-15 scores on POD2 - assess the number of opioid prescriptions required by patients in the 60 day recover period - assess KOOS pain and symptom scales at 8 weeks post-operatively between groups.

NCT ID: NCT06274008 Recruiting - Pain Clinical Trials

Exparel vs. ACB With Bupivacaine for ACL Reconstruction

Start date: October 12, 2023
Phase: Phase 1
Study type: Interventional

Opioid misuse and addiction among children and adolescents is an increasingly concerning problem. Post-surgical opioid prescriptions for commonly performed surgeries such as anterior cruciate ligament reconstruction (ACLR) increase opioid exposure in young athletes. The purpose of the current study is to determine if extended-release Bupivacaine Liposome Injectable Suspension (Exparel) is effective in decreasing at home narcotic consumption compared to standard Bupivacaine Adductor Canal Block for Anterior Cruciate Ligament (ACL) reconstruction/reconstruction for the surgical treatment of adolescents with ACL tears and concomitant pathology i.e. meniscus / cartilage injury/tear.

NCT ID: NCT06235736 Recruiting - ACL Tear Clinical Trials

Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?

ACL
Start date: January 17, 2024
Phase:
Study type: Observational

The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are: - Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (>10%) - Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants? - Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.

NCT ID: NCT06156501 Recruiting - ACL Tear Clinical Trials

Psychological Factors Influencing the Patient-reported and Functional Outcome of ACL Reconstruction and Their Sex-specific Differences

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Psychological parameters among patients undergoing ACL reconstruction and their impact on the patient-reported and functional outcome of reconstruction will be prospectively evaluated

NCT ID: NCT06096259 Not yet recruiting - Clinical trials for Osteoarthritis, Knee

Preventing Injured Knees From osteoArthritis: Severity Outcomes

PIKASO
Start date: December 2023
Phase: Phase 2
Study type: Interventional

This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.

NCT ID: NCT06063915 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases.

NCT ID: NCT05931627 Enrolling by invitation - ACL Injury Clinical Trials

Tourniquet Use in Anterior Cruciate Ligament Repair

Start date: March 8, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during ACL reconstruction. We hypothesize that: 1. Limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an ACL reconstruction. 2. Limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period. 3. Patients who undergo an ACL reconstruction with limited tourniquet use will have earlier return of quadriceps functions as compared to those undergoing reconstruction with the use of a tourniquet.

NCT ID: NCT05912777 Recruiting - ACL Tear Clinical Trials

3D Reconstruction of the Knee Based on MRI

IMAGENOU3D
Start date: September 13, 2023
Phase: N/A
Study type: Interventional

ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee and to diagnose lesions associated with rupture of the ACL (in particular meniscal lesions). Obtaining a 3D model of patients' joints from a imaging is of growing interest to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT. However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use.

NCT ID: NCT05876013 Completed - Surgery Clinical Trials

Reduced Knee Flexion Strength 18 Years After ACL Reconstruction in Hamstring Group Compared to Patellar Tendon Group

Studie ACL
Start date: March 14, 2022
Phase:
Study type: Observational

Background: Bone-patellar tendon-bone (BPTB) and a double-looped semitendinosus gracilis (hamstring group) graft are commonly used for ACL reconstruction. Short-term and mid-term studies show little to no significant difference between the two groups, and there are a few long term studies to compare results between the two grafts. Purpose: To compare the results after using either BPTB grafts or hamstring grafts 18 years after ACL reconstruction. Study design: Randomized controlled trial; Level of evidence II. Methods: 114 patients with ACL rupture between 2001 and 2004 were randomized to reconstruction with either BPTB graft or a hamstring graft. Patients were operated at four major hospitals. The 18-year follow-up evaluation included isokinetic testing of muscle strength, patient-reported outcome measures, clinical knee examination and an assessment of radiological osteoarthritis using the Kellgren-Lawrence classification. Hypothesis:Hypothesis is that there will be no difference in the long-term outcome between the two groups, as well hypothesis of no difference in patients with prosthesis after ACL reconstruction, arthrosis difference in operated knees and the rate of graft failure between the two groups. Previous follow-up studies showed a significant difference in total flexion work between the two groups, so detecting a persistent difference between the groups will be point of interest.

NCT ID: NCT05582226 Recruiting - ACL Tear Clinical Trials

Augmentation of Anterior Cruciate Ligament Reconstruction Using Mesenchymal Stem Cells and Collagen Matrix Carrier

BioACL
Start date: August 16, 2022
Phase: N/A
Study type: Interventional

The goal of this observational study is to compare patient outcomes for reconstructive surgery of ACL tears. This study utilizes two randomized groups, one being the control group that receives standard ACL reconstructive surgery, while the other is the test group at will receive an injection of stem cells taken from elsewhere within the body. The main objectives are to determine the usefulness of stem cells as a cost-effective implant in reconstructive surgery and to determine if the stem cells provide more optimized healing outcomes. Participants will: - Receive ACL reconstructive surgery as normal - One-half of the participants will receive stem cells at the repair site as the test group - All participants will have 3, 6, 9, 12, 18, and 24 month followups to chart their recovery progress Thus, the outcomes of the group receiving stem cell injections will be compared directly with the outcomes of the standard ACL reconstructive care group.