Clinical Research Directory

Post Operative Use of Neuromuscular Electrical Stimulation (NMES) Device for ACLR Patients

This study is being conducted to learn about how neuromuscular electrical stimulation (NMES) in addition to standard of care aids in the recovery of muscle strength in patients undergoing ACLR procedure.

Study of Functional Magnetic Resonance Signal Variations in Patients Undergoing Anterior Cruciate Ligament Reconstruction With the Application of a Dedicated Neuromotor Training

Lower limb injuries represent the majority of sports-related injuries, with knee injuries being among the most common. In particular, anterior cruciate ligament (ACL) injuries are considered highly devastating and career-threatening for both professional and amateur athletes. Current surgical and rehabilitation treatments often fail to provide fully satisfactory short- and long-term outcomes. A very high risk of re-injury exists, especially in younger patients, with up to 35% experiencing a second ACL injury, alongside a significant long-term risk of early knee osteoarthritis. Most ACL injuries are non-contact or indirect contact injuries, implicating biomechanical factors and neuromuscular control as key determinants of injury mechanisms. Recent literature shows that patients suffering a non-contact ACL injury have a higher risk of re-injury compared to those with contact injuries, suggesting a significant cognitive component in injury processing, surgery, rehabilitation, and return to sport. Recent rehabilitation studies have introduced targeted neuromotor training designed to "rebuild" biomechanical and neuromuscular patterns to avoid mechanisms leading to re-injury. Movement quality tests are used post-training to confirm the reduction of risky biomechanical patterns, often resulting in a score indicating movement quality. Given the brain's involvement in such injuries, pioneering studies have used functional magnetic resonance imaging (fMRI) to investigate changes in cortical brain areas following ACL injury and reconstruction. Evidence shows adaptations in both central and peripheral nervous systems, with altered sensorimotor cortex activation in patients during simple motor tasks, differing from healthy subjects. Prefrontal cortex alterations correlate with severe quadriceps muscle activation asymmetries, linking these brain patterns to post-injury return-to-sport outcomes. However, no studies have yet evaluated the interaction between cortical activation (neural compensations) measured by fMRI and outcomes from targeted neuromotor training during ACL rehabilitation. Understanding brain activation implications is crucial for developing large-scale rehabilitation protocols to reduce the risk of a second, potentially more devastating, knee injury. This study aims to reveal whether a neuromotor training protocol can positively influence cognitive brain areas related to human movement, particularly by reducing risky injury patterns. It will be the first to test whether dedicated neuromuscular training effectively reduces neural compensations and cortical activation related to non-automated movement, favoring automation areas important for a safe return to sport. Patients will directly benefit from participating in the innovative neuromotor training program, with functional MRI scans conducted before training begins (post-surgery) and after training completion. Indirectly, the study will assess whether neuromotor training can adapt patient neuromotor patterns to reduce re-injury risk, ultimately benefiting future patients undergoing ACL reconstruction.

Michigan Split-belt Treadmill Training Program to Improve Acute Knee Biomechanics After ACL Reconstruction

The goal of this study is to determine short-term adaptations (aftereffects) in knee loading after a 20-minute split-belt treadmill training session in patients with ACL reconstruction. Our main question for this aim are: 1. Are training-mediated aftereffects in the knee joint moment greater for tied-belt walking or split-belt walking? 2. Are training-mediated aftereffects in the knee joint moment different between subjects who train early stance knee loading versus subjects who train mid-stance knee loading?

Baseline ACL Injury Risk Screening and Normative Data

This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for one year following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.

ACL Reconstruction in Patients Aged 50 Years and Older

Anterior cruciate ligament (ACL) injury is one of the most common knee ligament injuries in athletes, and surgical ACL reconstruction is the treatment of choice to allow patients to return to sports and recreational activities. Surgical treatment restores joint kinematics, reduces the risk of subsequent injuries, and reduces the degenerative progression of the joint. With the increasing average age, life expectancy, and physical activity levels of the population over 50, ACL injuries are also becoming more frequent in this group. Traditionally, the treatment of choice for patients over 50 has been conservative, based on muscle-strengthening exercises and rescheduling of sports activity with lifestyle modifications to accommodate the joint deficit. Furthermore, some authors have demonstrated that ACL reconstruction in older patients can lead to a higher rate of complications such as stiffness, arthrofibrosis, infections, wound healing problems, or thromboembolic risks, as well as the fact that the presence of concomitant early degenerative osteoarthritis can prevent a satisfactory outcome. Furthermore, studies have shown that nonsurgical treatment may be the most cost-effective strategy in middle-aged patients with moderate activity levels. Currently, there is no consensus regarding the appropriateness of ACL reconstruction in patients over 50, as it is unclear whether there may be greater risks or whether the procedure may lead to more postoperative complications compared to younger patients. However, several studies have shown that in a middle-aged population with ACL deficiency, selected and motivated patients can experience significant recovery of joint function and stability after surgical reconstruction, with a satisfactory return to sports and recreational activities. There is now growing evidence that surgical treatment can offer favorable outcomes in patients over 50 in terms of knee stability and patient satisfaction, with results similar to those observed in a younger patient population. General Objective: The purpose of this study is to evaluate subjective and objective functional outcomes in patients over 50 undergoing ACL reconstruction, comparing them with a population under 40. The study's hypothesis is that ACL reconstruction surgery in patients over 50 will yield satisfactory clinical results, comparable to those in patients under 40. Primary Objective: The purpose of this study is to evaluate subjective and objective functional outcomes in patients over 50 undergoing ACL reconstruction at least two years after surgery. Secondary Objectives: Comparison of results with a population under 40. Patients to be Enrolled: The minimum sample size was estimated using subjective IKDC assessed at various time points after surgery in a group of patients over 50 years of age as the primary endpoint. The calculation was performed in G\*Power (v3.1.9.7) assuming an α error of 0.05, a power (1-β error) of 0.80, and an effect size of 0.625 (1). The minimum estimated sample size is 23 patients. Taking into account any dropouts, an additional 20% of patients will be considered, for a total of 28 patients. To evaluate the effectiveness of the intervention in patients over 50 years of age, subjective functional outcomes will be compared with those of an equal population under 40 years of age (n=28). Therefore, the study requires the enrollment of 56 total patients, 28 per group. A total of 56 patients were divided into the two groups described in the study. Inclusion Criteria: * Patients who underwent ACL reconstruction surgery from 2016 to 2021 at our Institute * Patients who were older than 50 or younger than 40 years of age at the time of surgery * Signed informed consent and agreed to participate in all study procedures Exclusion Criteria: Subjects meeting any of the following exclusion criteria will not be enrolled in the study: * Failure to provide informed consent * Patients undergoing combined anterior and posterior cruciate ligament reconstruction procedures, patients undergoing combined anterior cruciate ligament reconstruction and prosthetic surgery Patients enrolled in the study, after signing the informed consent form, will be contacted again to undergo routine assessment procedures, International Knee Documentation Committee (IKDC) score, ACL-RSI (Anterior Cruciate Ligament-Return to Sport after Injury) scale and Tegner activity scale, physical examination including ROM, stability tests such as Lachman and anterior drawer. Demographic variables (i.e., age, sex, body mass index) and surgical data will be collected by an independent researcher. Translational relevance: With increasing life expectancy and patient functional needs, and a projected doubling of the middle-aged population by 2050, this study aims to evaluate the effectiveness of ACL reconstruction surgery in subjects over 50 years of age.

Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population

Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.

ACL Reconstruction: Clinical Outcome

The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). The patients will be monitored and evaluated preoperatively and also at 6 months and 1, 2 and 5 years after the intervention through a clinical visit or telephone interview. Such assessments will include the administration of questionnaires to determine the patient's functional symptoms and the objective examination of the knee during a medical examination to quantify its stability.

Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes

The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety

Muscle O2 Saturation and Hemoglobin Levels During Rehabilitation From Arthroscopic Surgery

This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.

Augmentation of Partial Anterior Cruciate Ligament Tear: Early Results

Clinical evaluation for the patients with partial ACL tear who had ACL augmentation

Study to Use Oral Losartan to Decrease the Risk of Postoperative Scarring Following (ACL) Reconstruction

The purpose of this study to investigate the effect of using losartan (a blood pressure lowering drug with anti-scarring properties) on preventing primary postoperative arthrofibrosis (formation of abnormal scar tissue) in the knees in participants undergoing anterior cruciate ligament (ACL) repair surgery of their knee.

Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction

The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.

Rehabilitation Treatment of Anterior Cruciate Ligament Rupture

The purpose with this present study is to investigate the effect og a non-surgical regime in patients with an Anterior Cruciate ligament injury. The effect will be measured by patient reported outcome scores, level of function and how many of the patients are converting to operative treatment.

Michigan Split-belt Treadmill Training Program to Improve Long-Term Knee Biomechanics After ACL Reconstruction

The goal of this study is to gather pilot data to help inform a future clinical trial. As such, the investigators will employ a randomized clinical trial design, but data will only be collected on 9 total subjects. Nine subjects will be randomized to 2 split-belt intervention groups (one group where early stance loading is trained and the other where midstance loading is trained) and a placebo group. The goal of this study is to explore the adaptations in knee loading from a 6-week split-belt training intervention. The investigators' main question for this aim is: 1. Does knee loading, measured by the sagittal plane knee moment, change to a greater extent in the split-belt treadmill training groups compared to the placebo group? 2. Are there differences in training-related knee loading changes between individuals trained in the early stance vs. midstance loading split-belt training?

Effect of Contralateral NMES on Quadriceps Activation After ACL Injury or Surgery

A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. This can hinder rehabilitation processes, lead to impaired knee function, and negatively impact the patients' quality of life. The primary objective of this study is to assess whether voluntary quadriceps activation on the injured side is facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) on the contralateral quadriceps.

BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft

The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 12 weeks, and at 52 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).

Kinesio Taping for the Knee and Ankle: Acute Impact on Balance, Proprioception, and ACL Risk

This study aims to evaluate and compare the acute effects of Kinesio taping applied to the knee and ankle on balance, proprioception, and anterior cruciate ligament (ACL) injury risk using the Landing Error Scoring System (LESS). Designed as a randomized crossover trial, the study will include 24 healthy volleyball athletes with at least 5 years of experience. All participants will receive both ankle and knee taping interventions, separated by a one-week washout period. Assessments will be conducted at four time points: before and after each taping. Outcome measures include the Y-Balance Test, proprioception tests, and LESS.

Mindfulness and ACL Surgery

Anterior cruciate ligament (ACL) surgery patients experience physical trauma, both in the physical injury itself and following surgery, and face potential long-lasting adverse effects such as muscle weakness, diminished joint function, hip pain, and fear. Many of these patients report more significant anxiety and depression following surgery, which can further compound these patients' adverse outcomes. This study is a single-blind, randomized controlled trial design to evaluate the effects of a remotely-delivered 8-week mindfulness intervention on patient-reported outcomes (PROs) following ACL reconstruction surgery.

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

This is a multicenter randomized, placebo-controlled trial to assess whether a 6-month course of oral montelukast after ACL reconstruction reduces systemic markers of inflammation and biochemical and imaging biomarkers of cartilage degradation. This study will specifically target older ACL reconstruction patients with concomitant meniscal injuries as this group is at greatest risk of rapid PTOA progression. Patients will randomly be assigned to receive oral montelukast (10 mg) versus placebo daily for 6 months after surgery.

Tourniquet Use in Anterior Cruciate Ligament Repair

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.

Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain

The aim of this multi-centered study is to evaluate the effects of two distinct Adductor Canal Block (ACB) adjuncts, dexamethasone and dexmedetomidine, and their combination, on postoperative analgesia in patients undergoing Anterior Cruciate Ligament (ACL) Repair.

Comparison of Semitendinosus and Quadriceps Grafts for Anterior Cruciate Ligament Reconstruction

To investigate the differences between the two methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for young federated male football players. After surgery with quadricipital tendon graft or semitendinosus tendon graft, a two-year follow-up and the rate of return to sport are proposed.

MRI Morphology of Femoral Notch in ACL Injury

This study aims to investigate the association between femoral notch morphology, as assessed by MRI, and the risk of ACL injury

The Pediatric ALL Evaluation and Trial

The overall aim of this multicenter RCT is to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.