Clinical Research Directory

Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery

Anterior cruciate ligament (ACL) rupture is a common and clinically significant injury, particularly among young, active, and athletic adults, and may lead to knee instability and functional impairment. The resulting instability can limit activities of daily living and reduce sports performance, often increasing the need for surgical treatment in physically active individuals. Therefore, ACL reconstruction is widely accepted as an effective treatment option in appropriately selected patients. In the assessment of patients undergoing ACL reconstruction, not only postoperative clinical success but also the degree of preoperative instability may be important. Determining the effect of preoperative instability severity and side-to-side difference on postoperative functional outcomes, clinical recovery, radiological findings, return to daily activities, and return to sports may provide a more comprehensive and objective evaluation of surgical success. Although several studies have investigated clinical outcomes after ACL reconstruction, prospective studies evaluating the impact of preoperative instability on postoperative outcomes together with clinical, functional, and radiological parameters remain limited, particularly in our country. This prospective study aims to investigate the relationship between preoperative knee instability and postoperative clinical, functional, and radiological outcomes in patients undergoing ACL reconstruction at our institution. The findings are expected to contribute to the existing literature and provide useful information for clinical practice.

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.

Donor Ankle Sensorimotor Recovery After ACL Reconstruction With a Peroneus Longus Tendon Autograft

This prospective longitudinal observational cohort study will characterize recovery of donor-ankle sensorimotor function in adults who have undergone primary anterior cruciate ligament reconstruction using a peroneus longus tendon autograft. Twenty participants aged 18 to 55 years will be evaluated at postoperative 6-8 weeks, 3 months, and 6 months. The donor limb and the contralateral non-donor limb will be compared using surface electromyography of the peroneus longus, force-platform measures of postural control, inertial-sensor gait analysis, active ankle joint-position sense testing, and clinical and patient-reported foot and ankle function measures. The study does not assign the surgical procedure or rehabilitation treatment.

Neuromuscular Profiles After Anterior Cruciate Ligament Reconstruction

The NEURO-ACL-ISOEMG study is an observational, cross-sectional, exploratory study conducted in patients between 4 and 12 months after anterior cruciate ligament (ACL) reconstruction. The primary objective is to describe the joint distribution of isokinetic muscle strength and surface electromyographic (sEMG) activation parameters of the quadriceps and hamstrings in order to explore different neuromuscular profiles under clinical conditions. The study combines data from the routine functional assessment, including isokinetic strength measurements and a single-leg hop test, with surface electromyography and patient-reported questionnaires assessing knee self-efficacy, kinesiophobia, symptoms, and knee function.

Effect of Tourniquet Use on the Pivot Shift Test

This prospective study will evaluate whether tourniquet inflation affects the results of the pivot shift test in patients undergoing anterior cruciate ligament (ACL) reconstruction. The pivot shift test is commonly used to assess rotational instability of the knee in patients with ACL injury. In each participant, the pivot shift test will be performed under anesthesia before and after inflation of the thigh tourniquet, allowing the two conditions to be compared within the same patient. The study aims to determine whether tourniquet use changes the findings of the pivot shift examination. Understanding the possible influence of tourniquet inflation may help standardize intraoperative assessment of rotational knee instability and improve interpretation of the pivot shift test during ACL surgery.

Effects of Low-intensity Strength Training With Concomitant Blood Flow Restriction on Pain Perception in Patients With Anterior Cruciate Ligament Surgery

After surgical treatment of a tear of the anterior cruciate ligament, physiotherapeutic exercises are done as standard therapy. This is to achieve a rapid improvement in pain and knee function. In this study, the Investigators examine how low-intensity strength training with simultaneous restriction of blood flow works and whether it is effective and well tolerated. For this purpose, a pressure cuff is applied to the leg during training. Participation in this study will last four weeks for each participant. The Investigators will invite participants for 11 study visits. One appointment will last about 30 minutes. If a participant decides to take part in the study, they will be randomly assigned to one of two groups. The participants will belong to either an experimental group or the control group. In the experimental group, the participants will be treated with the intervention method. The intervention method involves 4 weeks of low-intensity strength training with an additional pressure cuff on the leg, which should lead to improved adaptations to the muscle as well as a reduction in pain. In the control group, the participants will receive the same strength training only without the additional pressure cuff. The benefit is that in addition to the participants actual rehabilitation program, each participant will receive free training to build their muscles. This could contribute to an accelerated rehabilitation process and a faster build-up of strength as well as an improvement in pain. It is additionally possible that the participants will help future patients with their participation. The intervention method for strength training with simultaneous restriction of blood flow (Blood Flow Restriction Training) has been studied for some time. There is good evidence of improved muscle, tendon and pain adaptations in both healthy individuals and patients with ACL injury. Whether this training method also has an effect on pain perception will be investigated in this study. Participants may experience side effects if they are treated with the intervention method (low-intensity strength training with simultaneous restriction of blood flow). The Investigators may not yet know all the risks and side effects of the intervention method. So far, the following risks and side effects are known: * Temporay numbness * Muscle soreness * Pressure sensation

Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction

Operating room noise may interfere with communication, concentration, and surgical workflow. Active noise-cancelling (ANC) headphones can reduce background auditory distractions; however, their potential benefit during surgery may depend on maintaining effective communication among surgical team members. This prospective randomized controlled trial evaluates the effect of ANC headphones integrated with a closed-loop communication system on operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament (ACL) reconstruction. Participants undergoing primary arthroscopic ACL reconstruction are randomized to either an ANC group or a control group. In the ANC group, the surgeon, first assistant, and scrub nurse use ANC headphones connected through a closed-loop communication system during surgery. The control group undergoes surgery under standard operating room conditions. The primary outcome is operative time from skin incision to skin closure. Secondary outcomes include command acknowledgment time, instrument handover time, and repeated verbal requests assessed using objective video-based workflow analysis.

Psychological Readiness and Return to Sport After ACL Reconstruction

The goal of this observational study is to evaluate psychological readiness, kinesiophobia, subjective knee function, sport activity level, and return-to-sport status in athletes who have undergone primary anterior cruciate ligament (ACL) reconstruction between 3 and 24 months after surgery. The main questions it aims to answer are: Do these outcomes differ across different postoperative time periods? Are they associated with return-to-sport status? Participants will complete questionnaires assessing psychological readiness (ACL-RSI), kinesiophobia (TSK), subjective knee function (IKDC), and sport activity level (Tegner), and will provide information about their return-to-sport status.

Virtual Reality Mindfulness Meditation After ACL Reconstruction

To evaluate the effect of virtual reality mindfulness meditation on patients after ACLR, the investigators will determine the effect of virtual reality mindfulness meditation to 1) decrease self-reported injury-related fear, 2) improve poor jump-landing movement patterns, and 3) improve brain activity in women 1 to 5 years post-ACLR when compared to a virtual reality sham group.

Relationship Between Muscle Strength and Balance

This study aims to examine the relationship between lower extremity muscle strength and balance and to compare these parameters between healthy individuals and individuals with lower extremity injuries.

Effect of Adding Vastus Medialis Nerve Block to Adductor Canal Block After Anterior Cruciate Ligament Reconstruction

Anterior cruciate ligament (ACL) reconstruction is frequently associated with moderate to severe postoperative pain, which can delay mobilization and rehabilitation. The adductor canal block (ACB) is widely used for postoperative pain management because it provides effective analgesia while preserving quadriceps muscle strength. However, pain originating from the medial aspect of the knee may not be adequately controlled with ACB alone because the nerve to the vastus medialis may not be consistently anesthetized. This prospective randomized controlled trial evaluates whether adding a vastus medialis nerve block (VMNB) to a standard adductor canal block improves postoperative pain control in patients undergoing elective arthroscopic ACL reconstruction. Participants are randomly assigned to receive either ACB alone or ACB combined with VMNB before surgery, while all patients receive the same standardized general anesthesia, surgical technique, and postoperative analgesic regimen. The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS) at 1, 6, 12, and 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, time to first mobilization, length of hospital stay, and block-related complications. The results of this study may help determine whether the addition of a vastus medialis nerve block provides clinically meaningful benefits and may contribute to improving postoperative pain management following ACL reconstruction.

Quadriceps Tendon vs Peroneus Longus Tendon in ACL Reconstruction

This prospective randomized clinical trial aims to compare quadriceps tendon and peroneus longus tendon autografts in anterior cruciate ligament reconstruction. Patients with anterior cruciate ligament injury undergoing primary reconstruction surgery will be randomly assigned to one of the two graft groups. Clinical examination findings, return-to-sport outcomes, ankle muscle strength, ankle-related functional scores, and gait analysis parameters will be evaluated at 6 months and 12 months postoperatively. The study aims to investigate both knee-related functional outcomes and donor site morbidity associated with graft harvesting techniques.

Biologic Augmentation With Mesenchymal Stem Cells in Patients Undergoing Anterior Cruciate Ligament Reconstruction

This study will evaluate the efficacy of biologic augmentation of ACL reconstruction with bone marrow derived mesenchymal stem cells as measured by magnetic resonance imaging to detect graft healing and integration. Secondary endpoints will include validated patient reported outcome measures, as well as functional outcome using objective examination findings.

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1292 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.

Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

Background Prehabilitation prior to anterior cruciate ligament reconstruction (ACLR) has been shown to improve preoperative knee function, enhance quadriceps strength, and optimize postoperative recovery. However, access to supervised prehabilitation programmes remains limited. Digital health interventions may improve accessibility, adherence, and continuity of care. Objective To determine whether a structured digital prehabilitation programme is more effective than usual care in improving quadriceps strength and functional outcomes after ACL reconstruction. Methods/design This study is a single-centre, parallel-group, assessor-blinded randomised controlled trial. Adult participants scheduled for primary ACL reconstruction will be randomly allocated to either a usual care group or a digital prehabilitation group. The intervention group will complete a 4-week structured digital prehabilitation programme prior to surgery. Outcomes will be assessed preoperatively and up to 12 weeks postoperatively. Expected Results The digital prehabilitation programme is expected to improve preoperative knee status and enhance postoperative quadriceps strength and functional recovery compared to usual care.

Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

ACL Prehabilitation and Functional Outcomes

Anterior cruciate ligament (ACL) rupture is a common knee injury that frequently requires surgical reconstruction and extensive postoperative rehabilitation. Preoperative rehabilitation (prehabilitation) has been suggested as a strategy to optimize physical function before surgery and enhance postoperative recovery. This prospective randomized controlled trial aims to evaluate the effectiveness of a structured six-week prehabilitation program on functional outcomes following anterior cruciate ligament reconstruction (ACLR). Seventy-six participants with complete ACL rupture scheduled for primary ACLR were randomly assigned to either a prehabilitation group or a control group receiving standard preoperative care. The prehabilitation program consisted of progressive strengthening exercises, neuromuscular training, balance exercises, and functional movement training performed three times per week. Functional outcomes were assessed at baseline, immediately before surgery, and at three and six months postoperatively using the International Knee Documentation Committee (IKDC) Score, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Tegner Activity Scale, and the Single-Leg Hop Test. The study aims to determine whether preoperative prehabilitation predicts improved postoperative functional recovery after ACL reconstruction and to provide evidence for optimizing rehabilitation strategies in this patient population.

Achilles Allograft With or Without InternalBrace for ACL Revision Surgery

This study evaluated outcomes after revision anterior cruciate ligament reconstruction using Achilles tendon allografts with a calcaneal bone block, with or without additional InternalBrace augmentation. Revision ACL reconstruction is often more complex than primary ACL reconstruction because previous surgery may leave widened bone tunnels or bone defects. Achilles tendon allografts with attached bone blocks may help address these defects and allow reconstruction in a single surgical procedure. Participants with MRI-confirmed ACL graft re-tear and clinical knee instability were randomized to undergo revision ACL reconstruction either with InternalBrace augmentation or without InternalBrace augmentation. Clinical outcomes, patient-reported knee function, health-related quality of life, and MRI findings were assessed during 13 months of follow-up. The study was designed as a prospective randomized controlled pilot trial to compare whether additional InternalBrace augmentation improved functional, radiographic, or quality-of-life outcomes after revision ACL surgery.

BPTB Versus Hamstring Autografts in ACL Reconstruction Among Professional Athletes

This prospective randomized controlled study compares outcomes of ACL reconstruction using bone-patellar tendon-bone (BPTB) versus hamstring tendon (HT) autografts in professional athletes. The primary outcome is isokinetic muscle strength assessment. Secondary outcomes include IKDC score, return to athletic activity, and complication rates. Patients are followed for five years.

Acute Anterior Cruciate Ligament Rupture; RecOnsTruction Or Repair?

To investigate the hypothesis that suture repair of a ruptured vkb, combined with a dynamic intraligamentary stabilization and microfracture of the femoral notch, results in at least equal effectiveness compared with an ACL reconstruction using autologous hamstring in terms of functional recovery one year postoperatively in terms of a patient self-reported outcome related to be able to conduct daily and sporting activities. Secondary, the evaluation of clinical outcomes, self-reported by the patient outcomes, osteoarthritis, rehabilitation time required for return to daily and sporting activities and levels of sporting activity which has returned in patients with status after an ACL rupture and suture repair augmented with a dynamic intraligamentary microfracture and stabilization of the femoral notch in comparison with an anterior cruciate ligament reconstruction with the ipsilateral hamstring graft.

Effects of a Targeted Prevention Program on Change-of-Direction Biomechanics and Performance in Elite Female Soccer Players

Anterior cruciate ligament (ACL) injuries are common in female soccer and frequently occur during change-of-direction (COD) movements without contact. Biomechanical deficits during these movements are considered important risk factors. This study aims to evaluate the effects of a targeted injury-prevention program on biomechanical movement quality and performance during change-of-direction tasks in female soccer players. Participants will perform a 90° cutting task during which biomechanical movement quality will be assessed using the Cutting Movement Assessment Score (CMAS), while performance will be evaluated using cutting time measured with photoelectric timing gates. Participants will also perform the 505 Agility Test to assess additional change-of-direction performance. In addition, subjective perceptions of functional confidence and performance will be collected using Likert-scale questionnaires. The study will assess whether a structured prevention program integrated into regular training can improve biomechanical movement patterns and change-of-direction performance.

Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction

The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.

Sports Rehabilitation Therapy for Knee Joint Sports Injuries: A Case Study of Anterior Cruciate Ligament Injury and Patellar Chondromalacia

The primary objective of this clinical trial is to verify the superiority of a digital diagnosis and treatment system for the conservative management of knee sports injuries-based on wearable sensors, machine vision, and large language models-over conventional off-site rehabilitation in terms of functional outcomes. The secondary objectives include assessing safety and adverse events, compliance and feasibility, algorithm evaluation accuracy and usability, and generating clinical evidence to support the registration of a Class II medical device. Participants will undergo a six-month intervention comprising knee muscle strengthening exercises, lower limb balance and stability training, and stretching exercises. Follow-up assessments will be conducted every four weeks, recording IKDC and Lysholm subjective knee function scores, VAS pain scores, SF-36 quality of life scores, knee range of motion, and MRI findings.