Clinical Research Directory

Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction

To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.

Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction

This prospective, single-center, single-arm observational cohort study aims to evaluate the clinical, radiological, and arthroscopic outcomes and safety of primary anterior cruciate ligament (ACL) reconstruction augmented with the BioBrace® Reinforced BioInductive Implant. A total of 30 patients who decided to undergo BioBrace-augmented ACL reconstruction in routine clinical practice will be followed for up to 24 months postoperatively. Knee stability, graft maturation via MRI and second-look arthroscopy, patient-reported outcomes, and complications will be assessed.

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction

Background: Arthroscopic anterior cruciate ligament reconstruction (ACLR) is a common orthopedic surgery. Postoperative pain, inflammatory response and opioid-related adverse events impair early recovery quality. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique with potential analgesic and anti-inflammatory effects. Participants: A total of 144 eligible participants undergoing ACLR under spinal anesthesia combined with an adductor canal block will be enrolled. Methods: This prospective, randomized, double-blind, sham-controlled trial will evaluate the effects of perioperative taVNS on early postoperative recovery. Participants will be randomly assigned in a 1:1 ratio to receive active taVNS or sham stimulation. Each participant will receive three 30-minute stimulation sessions, scheduled 30-45 minutes before surgery, 6 ± 1 hours after surgery, and 18 ± 1 hours after surgery. All participants will receive standardized multimodal postoperative analgesia. The primary outcome will be the score on the 15-item Quality of Recovery (QoR-15) questionnaire at 24 hours after surgery. Secondary outcomes will include rescue opioid consumption expressed as oral morphine equivalents, pain scores measured using the Numeric Rating Scale (NRS), functional recovery, and adverse events. Conclusion: The investigators hypothesize that perioperative taVNS will improve early postoperative recovery quality after ACLR.

Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction

The goal of this clinical trial is to learn whether taking oral tranexamic acid (TXA) for one week after anterior cruciate ligament (ACL) reconstruction improves recovery in adolescents and young adults aged 14 to 25 years. All participants receive standard intravenous TXA during surgery. The main questions it aims to answer are: * Does oral TXA lower knee pain at 2 weeks after surgery? * Does oral TXA reduce the amount of opioid pain medicine used in the first 2 weeks? * Does oral TXA improve knee range of motion at 2 weeks? Researchers will compare oral TXA to a placebo (a look-alike capsule with no active drug) to see if oral TXA improves pain, opioid use, motion, strength, knee function, and return to sport. Participants will: * Take 3 capsules (oral TXA or placebo) once a day for the first 8 days after surgery (day of surgery through day 7) * Keep a home diary for 2 weeks recording pain scores, opioid pills taken and any side effects * Return for study visits at 2 weeks, 6 weeks, 12 weeks, 6 months, 9 months and 1 year for pain, motion, strength and function testing * Complete a survey at 2 years

Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program

The goal of this clinical trial is to learn whether an online mental and emotional support program called ACL Unbroken can help people recovering from ACL reconstruction surgery feel more confident and ready to return to sports when used alongside standard physical therapy. The main questions this study aims to answer are: * Does the ACL Unbroken program help people feel more mentally prepared and confident to return to sports after ACL surgery? * Does the ACL Unbroken program improve recovery outcomes, such as physical performance, return to sports participation, satisfaction with recovery, and reducing the risk of another ACL injury? Participants in the study will: * Continue to receive their usual physical therapy and medical care prescribed by their healthcare providers. * Complete surveys and assessments about their recovery, confidence, readiness to return to sports, and overall recovery experience. * Be assigned to one of two groups by chance. * If assigned to the intervention group, receive access to the ACL Unbroken online program, which includes educational lessons and activities focused on goal setting, confidence building, coping with fear of re-injury, stress management, motivation, mindfulness, meditation, visualization, and resilience during recovery. * If assigned to the comparison group, not receive access to the ACL Unbroken program during the study period. If there is a comparison group, researchers will compare participants who receive the ACL Unbroken program with participants who receive standard care alone to see whether the program improves psychological readiness, recovery outcomes, and return-to-sport success after ACL reconstruction surgery.

Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis

This study aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. The over-the-top ACL-R technique, which involves routing the graft over the posterior aspect of the lateral femoral condyle, is known for its simplicity and ability to preserve the anatomical footprint of the ACL. Although a non-anatomical reconstruction, the OTT technique has shown comparable clinical results and good return to sports (RTS) ratios when compared to the conventional ACLR alone. It is also favored in revision surgeries or when there is difficulty accessing the femoral tunnel through conventional approaches. However, concerns regarding its ability to fully restore rotational stability persist, especially in high-demand athletes. In contrast, the anteromedial portal technique for ACL-R, combined with LET, has gained popularity due to its effectiveness in controlling both anterior tibial translation and rotational instability. LET augments the intra-articular reconstruction by providing additional restraint against pivot shifts, which can be critical in patients with high-risk profiles for re-injury, such as those participating in pivoting sports. Comparing these two approaches in terms of clinical outcomes, graft integrity, rotational control, and return-to-sport rates with a prospectively randomized controlled trial will help clarify their roles in contemporary ACL surgery and could guide surgeons in choosing the most appropriate method based on patient-specific factors.

Perturbation Training vs Functional Activities on Pain, ROM, Balance, and Function Post-ACL

Anterior cruciate ligament (ACL) injuries are among the most common and functionally disabling knee injuries, particularly in physically active individuals. Despite advancements in surgical techniques, optimal post-operative rehabilitation remains critical for successful functional recovery, minimizing re-injury risk, and restoring pre-injury performance levels

Knee Extension Deficit Following an Anterior Cruciate Ligament Reconstruction (Extension Loss)

Knee extension loss following an anterior cruciate ligament (ACL) reconstruction is believed to play an important role in quadriceps strength recovery. One of the main goals of the rehabilitation following ACL reconstruction is to restore knee extensor muscle strength. Deficits of more than a five-degree extension range of motion (ROM) could lead to delayed knee functionality and anterior knee pain. However, the effect of knee extension deficits in the early postoperative phase of the ACL reconstruction on knee extensor muscle strength recovery and knee functionality is not yet known. This study aimed to investigate the difference between knee extensor muscle strength recovery and knee functionality in patients with ACL repair who had a knee extension ROM deficit (\>5°) in the early postoperative period and those who did not.

Reduce Opiate Exposure With ACL Surgery

This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).

Werewolf Flow 50 During ACL Reconstruction

The aim of this study is to compare the outcomes, ease of use, and cost of the Werewolf FLOW50 device to the institutional standard of care which is does not include the use of electrocautery devices during anterior cruciate ligament reconstruction (ACLR) surgery in patients 12-18 years of age using a randomized control trial design. The investigators hypothesize that a lower proportion of participants who undergo ACLR and are randomized to the Werewolf FLOW50 procedure will experience post-operative arthrofibrosis compared to those randomized to standard of care (control group).

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

ACL Mechanical Property Changes in Female Collegiate Basketball Players During a Competitive Season

This prospective cohort study aims to investigate whether the mechanical properties of the anterior cruciate ligament (ACL) undergo measurable changes throughout a competitive basketball season in female collegiate athletes. Female athletes are at a significantly higher risk for non-contact ACL injuries compared to males. Beyond acute injuries, cumulative stress from high-intensity sports may lead to subclinical alterations in the ligament's biomechanical properties, potentially increasing injury risk. Using non-invasive shear wave elastography (SWE) and countermovement jump (CMJ) tests, the study will monitor 60 elite players before and after the University Basketball League (UBL) season. The findings will help identify potential signs of cumulative loading and contribute to the development of early detection markers for injury risk in female athletes.

Anterior Cruciate Ligament Recovery With Virtual Psychological Intervention

The goal of this parallel arm prospective randomized control trial study is to compare outcomes in Anterior Cruciate Ligament Reconstruction (ACLR) Surgery patients after exposure to a virtual psychological intervention (VPI) versus standard care. The main question the investigators are asking is if virtual administration of psychological CBT modules will be an accessible and convenient vehicle to improve ACLR outcomes. Participants will be placed either into a treatment group receiving virtual modules of cognitive behavioral therapy in addition to standard of care ACLR surgery or the control group receiving only the standard of care ACLR surgery. The investigators hypothesize that ACLR patients in the VPI cohort will have improved return to sport and post operative outcomes compared to controls.

Comparative Study of Functional Outcomes Between Peroneus Longus and Hamstring Tendon Autografts in Arthroscopic ACL Reconstruction

This is a prospective, single-blinded, randomized controlled trial. Sixty patients (≥18 years) with an isolated ACL injury will be randomly assigned to receive an ACL reconstruction using either a Peroneus Longus Tendon (PLT) autograft or a Hamstring Tendon (HST) autograft. The primary objective is to compare early functional outcomes between the two groups at 6 weeks and 3 months post-surgery, using the Lysholm Knee Score. The study aims to demonstrate the non-inferiority of the PLT graft. All surgeries will be performed arthroscopically at Khyber Teaching Hospital, Peshawar, followed by a standardized rehabilitation protocol.

Utilization of a 3D Printed Customized Knee Extender and At-Home Rehabilitation Program on Patient Outcomes Following ACL Surgery

The purpose of this study is to explore patient outcomes associated with, the use of a 3D printed knee extender device, in conjunction with an at-home rehabilitation program, for patients who are performing knee rehabilitation after anterior cruciate ligament (ACL) surgery.

A Study Of Focused Shockwave For Anterior Knee Pain Following Anterior Cruciate Ligament Reconstruction

The purpose of this study is to investigate whether Focused Shockwave (FSW) therapy reduces anterior knee pain following anterior cruciate ligament reconstruction (ACL-R) with bone-patellar tendon-bone (BTB) or quadriceps tendon (QT) autografts.

Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury

Background: Arthroscopic anterior cruciate ligament(ACL) reconstruction is so far the gold standard for the treatment of ACL ruptures, but this technique still suffers from problems of tendon-bone healing, bone tunnel enlargement, bone resorption, a low rate of return to motion,etc. In recent years, due to the innovation of medical materials and surgical techniques, anterior cruciate ligament repair technology has returned to the field of vision of clinical doctors. This technique has the advantages of preserving the natural ligaments and their proprioceptive sensation, avoiding the bone injury of the tunnel and the complications of the donor site. However, there is still a lack of high-quality clinical randomized controlled trails to provide evidence of the effect of arthroscopic ACL repair. Hypothesis: Arthroscopic ACL repair is comparable to ACL reconstruction in patients with ACL tears (Sherman grades I and II). Study Design: This study was a prospective, multicenter, randomized, double-blinded, parallel-controlled, non-inferiority trial design. A total of 330 patients with ACL tears were randomly divided into 2 groups, and were randomly assigned to the experimental group (arthroscopic anterior cruciate ligament repair) and the control group (arthroscopic anterior cruciate ligament reconstruction) according to 1:1. Follow-up knee function and other scores were performed at 3 months, 6 months, 1 year, and 2 years after surgery, and the total study time is expected to be 3 years.

Graft Type and Outcomes After ACL Reconstruction in Female Athletes

This prospective multicenter cohort study aims to compare clinical and functional outcomes between hamstring tendon and quadriceps tendon autografts in anterior cruciate ligament (ACL) reconstruction in female athletes. Participants will be followed for two years after surgery to evaluate graft failure rates, return to sport, knee stability, and patient-reported outcomes.

Postoperative Analgesic Efficacy of ACB+iPACK vs FTB+Selective Tibial+Obturator Blocks in ACL Reconstruction

This prospective, comparative study aims to evaluate the postoperative analgesic efficacy of ultrasound-guided Adductor Canal Block (ACB) combined with iPACK block versus Femoral Triangle Block (FTB) combined with selective tibial nerve block and obturator nerve block in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction. The primary objective is to determine which regional anesthesia regimen provides superior pain relief at rest and during movement. The secondary objectives include assessing morphine consumption, motor blockade using the Bromage score, patient satisfaction, and potential adverse effects of these anesthesia techniques.

Tendon-Bone Versus All-Soft-Tissue for ACL Reconstruction: A Patient-Blinded Randomized Clinical Trial

In primary pediatric Anterior cruciate ligament (ACL) reconstruction, the quadriceps tendon with either tendon and patellar bone or an all-tendon graft is commonly employed. However, no randomized control trial has sought to discern the superior graft option in regards to both short-term and long-term patient outcomes.The purpose of this study is to assess the differences between these two widely used surgical techniques in ACL reconstruction by examining short, intermediate, and long term outcomes of both approaches.

Effects of Whole Body Vibration on Quadriceps Function, Landing Biomechanics, and Performance in Individuals With ACL Reconstruction

Individuals who undergo anterior cruciate ligament reconstruction (ACLR) are at heightened risk of secondary anterior cruciate ligament (ACL) injury (e.g. additional injury to the ACL in either knee). One of the primary physiological consequences of ACLR is the presence of quadriceps dysfunction (i.e. reduced activation and strength) which has been linked to altered gait and landing biomechanics. Aberrant landing biomechanics have been associated with an increased risk of both primary and secondary ACL injury, thus additional research is needed to evaluate the efficacy of treatments aimed to reduce quadriceps dysfunction and restore adequate landing biomechanics in attempts to reduce secondary ACL injury. Whole-body Vibration (WBV) has demonstrated success in improving quadriceps function and gait biomechanics in individuals with ACLR, however its effectiveness on landing biomechanics is unknown. To evaluate the acute effects of WBV on landing biomechanics in those with ACLR, a non-randomized crossover-controlled trial was conducted to determine if a single bout of WBV improved landing biomechanics greater than a control condition. Participants completed two separate testing sessions (separated by at least one week) in which measures of quadriceps function and landing biomechanics were assessed before and after either a control (no WBV) or WBV intervention. Separate linear mixed-effects models of post-test values for each dependent outcome were conducted with condition (control vs WBV) and limb (ACLR vs Uninvolved) as an interaction term, and each condition pre-test values and time post-ACLR as fixed effect covariates and a random effect of subject. The investigators expect to observe a significant improvement in landing biomechanics following WBV compared to the control condition.

Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation

The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

Gait Rehabilitation to Treat FastOA

The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.

Quadriceps Tendon Versus Bone Patellar Tendon Bone Autograft ACL Reconstruction RCT

The choice of autograft for ACL reconstruction continues to be debated. To date, there has only be one completed randomized controlled trial with quad tendon to BTB and the tendon included a bone plug. There has been no study to date comparing an all soft tissue quad tendon to patellar tendon in a randomized controlled trial for ACL reconstruction.