Clinical Research Directory

Menstrual Cycle-Synced Neuromuscular Training

This is a research study of female athletes participating in at least one running/cutting sport, who have no current conditions that would limit ability to perform sport-like movement tasks (such as running or jumping), and have reported to be post-menarche (a regular period). The purpose of this study is to leverage the menstrual cycle (MC) to improve the success of a neuromuscular training program (NTP) that has been shown to reduce high-risk movement patterns in adolescent females. The findings of this study may not only help develop more effective, personalized injury prevention strategies for female athletes, but may also have the potential to reduce ACL injury rates while improving long-term physical activity and health for active females. The researchers hope that this information may help reduce ACL injury rates and enhance long-term musculoskeletal health in female athletes, while promoting greater equity in sports medicine and performance training. Participants will be asked to wear an Oura Ring (a ring that is placed on a finger of the non-dominant hand) that will be used to track their menstrual cycle phases. The Oura Ring will be connected using a software called "Natural Cycles", which will sync to either a smart phone via Bluetooth, or data from the device can be downloaded to an iPad utilized by the research team. Participants will also take part in an 8-week Neuromuscular Training Program (NTP), that consists of two 30-minute training sessions per week, which will include dynamic exercises designed to improve strength and power, balance, and stability, as well as help to build a foundation of muscular endurance. Before starting the training program, participants will be asked to complete several questionnaires focused on activity level, sport participation characteristics, sport-related injury history, and menstrual cycle history, and both before and after completing the training program, participant movement patterns may be evaluated. For the training program, participants will be randomized into one of two groups - one that syncs the training type to the participant's menstrual cycle and one that does not. All participants will receive the same exercises, however, a participant's assigned group will determine when they receive certain exercises. Participation in this study is completely voluntary. Participation is expected to last up to 7 months. This is a minimal risk research study. There is a small risk of falling during movement tasks, skin irritation from tape that is used during movement evaluation, psychological stress from survey questions, and loss of confidentiality. To minimize these risks, participants may request rest breaks or stop participating at any time. Participants may also refuse to answer any questions that are asked, and all information collected from this research will be stored in a secure electronic database. This information known as "data" will not be shared with any person outside of the study team. There is no benefit to participants who participate in this research study. However, the investigators hope the information gathered from this research may benefit others in the future.

Clinical and Biomechanical Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction Associated With Lateral Extra-articular Tenodesis (LET)

The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee joint, and its injury is among the most common soft tissue injuries of the knee. Several surgical reconstruction techniques are available, utilizing various tissues as a graft for the neo-ligament, including both autografts and allografts. The "Over-the-top single-bundle technique with gracilis and semitendinosus tendons combined with lateral extra-articular tenodesis (LET)" was developed in 1998 by Prof. Marcacci and Prof. Zaffagnini, and it is still the preferred method for ACL reconstruction at the Second Clinic of the Rizzoli Orthopaedic Institute. Cadaveric biomechanical studies have shown that combining LET with ACL reconstruction improves knee joint stability in both the anteroposterior and rotational planes. However, a recent in vivo study has challenged this hypothesis, showing that in patients undergoing surgery, the addition of LET enhances knee stability only in the anteroposterior direction and only for a limited period of six months. At twelve months postoperatively, joint laxity appeared similar to that of patients who did not undergo the additional procedure. Furthermore, the same study did not assess rotational instability using the pivot-shift test, an essential parameter as it is closely linked to knee stability and the patient's subjective perception of surgical success. Despite the increasing use of LET in conjunction with ACL reconstruction, few studies have analyzed the short-term postoperative effects of lateral extra-articular tenodesis and its potential benefits during the early stages of rehabilitation and return to sport. This study was conceived in response to this clinical question, with the goal of evaluating anteroposterior and rotational laxity in a group of patients who underwent ACL reconstruction combined with LET, in order to analyze clinical outcomes and, most importantly, any changes in stability during the early postoperative period. The results aim to improve understanding of knee stability in the initial phase following surgery, providing valuable information for rehabilitation teams to optimize recovery protocols and more effectively guide return-to-sport decisions for patients undergoing both procedures.

Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy

This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.

Non-Narcotic Pain Control After ACL Reconstruction

This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.

Developing and Validating the Risk-taking Intention and Sport Engagement After ACL Reconstruction (RISE-ACL) Scale

Psychological factors play a critical role in recovery following anterior cruciate ligament (ACL) reconstruction. While tools such as the ACL - Return to Sport after Injury (ACL-RSI) focus on psychological readiness, emphasizing fear, hesitation, and apprehension, the opposite spectrum-overconfidence and risk-taking behaviors-remains underexplored. These behaviors can lead to premature return to high-risk activities and an increased likelihood of re-injury. To address this gap, we propose the development and validation of the RISE-ACL scale for assessing Risk-taking Intention and Sport Engagement after ACL reconstruction. This scale will assess key factors such as patients' willingness to engage in high-impact activities, their adherence to medical guidance, and their perceived readiness to resume sports despite potential physical or psychological limitations. The RISE-ACL Scale will complement existing tools like the ACL-RSI by focusing on overconfidence and risk-taking, offering clinicians a more balanced perspective on psychological recovery. Validation of the scale will involve testing its validity, reliability and clinical utility to ensure accurate identification of at-risk individuals. By providing actionable insights, the RISE-ACL Scale will help enhance post-operative care, promote safer return-to-play decisions, and optimize long-term outcomes through a comprehensive assessment of psychological and behavioral factors.

Radiographic Findings and Clinical Outcomes After Bone Grafting Patellar Defect in ACL Reconstruction

All patients will be randomly assigned using a computer randomization algorithm to one of two matched cohort groups. Patients will not be advised which group they belong to until after the completion of the study. One group will be treated with autologous bone graft for bone patellar-tendon bone (BTB) Anterior Cruciate Ligament Reconstruction (ACLR), and the other group will be treated with commercially available DBM (Demineralized bone matrix) putty. Patients will be enrolled from Banner University. Before and after surgery, patient reported outcomes including visual analog pain scale (VAS), Tegner-Lysholm and Cincinnati ACL Test. The principal investigator will evaluate the patients on subjective criteria such as pain and objective criteria including range of motion, arthritic changes seen on radiographs, infection, and ability to kneel.

Assessment of Quadriceps Femoris Muscle Function in Patients After Arthroscopic Knee Surgery in Outpatient Rehabilitation

The goal of this clinical trial is to learn if a high intensity magnetic field is an effective way to treat quadriceps muscle atrophy after knee arthroscopic surgery in adult patients. The main questions it aims to answer are: Is high intensity magnetic field muscle stimulation is an effective way to treat quadriceps muscle atrophy Is high intensity magnetic field muscle stimulation is more effective and more tolerable option for quadriceps muscle stimulation than transcutaneous muscle electrical stimulation Researchers will compare high intensity magnetic field muscle stimulation to transcutaneous muscle electrical stimulation and control group, to see if high intensity magnetic field muscle stimulation works to treat quadriceps muscle atrophy. Participants will: receive high intensity magnetic field or transcutaneous muscle electrical stimulation 1 time/day for 14 days, Visit the rehabilitation department for testing before/after and 1 month after rehabilitation.

Clinical and MRI Evaluation of ACL Reconstruction Results in Adolescents With Follow-up at Least 3 Years.

In this retrospective research results of ACL reconstruction in adolescent will be evaluated. As we know ACL ruptures become more frequent and more often operated these days. According to literature the results in patients younger than 20 years old are worse. Therefore clinical and MRI evaluation will be performed. The aim of the study is to assess subjective and objective functional outcome of ACL reconstruction with follow-up at least 3 years. MRI scans will be evaluated to highlight any early signs of osteoarthritis and describe graft morphology. IKDC, KOOS scales will be utilised for subjective evaluation. Clinical tests such as Lachman's, pivot shift, Appley's along with anterior tibial shift measurement with digital arthrometer for objective assessment will be also performed. Additionally isokinetic tests will be performed in two speeds of 60 and 180 deg/s. Most of important isokinetic parameters such as peak torque, torque in 30 deg, time to peak torque, peak torque to body weight both for quadriceps and hamstrings will be measured . Preliminary group of patients consists of 150 cases with follow-up at least 3 years, operated in age 12-17 years. All cases available for the study will be assessed with methodology above. Dedicated statistical test will be utilised to evaluate the results.