Anterior Cruciate Ligament (ACL) injury involves damage to a key ligament in the knee that is often studied through clinical trials to improve treatment and recovery strategies. Clinical research explores various surgical and non-surgical treatment e...

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Found 153 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying patients with isolated anterior cruciate ligament (ACL) ruptures, specifically proximal tears, to understand the long-term outcomes of surgical repair. This observational study focuses on the relapse rate over five years following surgery for proximal ACL tears. The study highlights that treatment decisions depend on factors such as patient symptoms, activity level, and injury severity, with functional treatment often reserved for low-demand patients and surgery considered for others, especially athletes. Surgical repair involves fixing the torn ACL, an approach that has regained interest due to new fixation devices. This method differs from the more common ligament replacement using knee tendons. The study includes patients who had surgical repair of a proximal ACL tear between January 2019 and July 2021. Functional treatment approaches, including splints and rehabilitation, are also described but are not the focus of this study. Participants will be monitored to track the rate of ACL rupture relapse over a five-year period. Assessments include evaluations of knee stability and function, and researchers will collect data related to the surgical repair's long-term success. The study aims to provide detailed follow-up information to better understand outcomes after proximal ACL repair surgery.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Researchers are evaluating the effect of semiconductor fabric sleeves on recovery after Anterior Cruciate Ligament (ACL) or ACL plus Meniscus arthroscopic surgery. The study aims to determine whether semiconductor sleeves improve functional outcomes and if they help patients recover faster compared to placebo sleeves that look similar but contain no semiconductor material. The trial is a randomized, double-blinded, placebo-controlled prospective clinical study led by the Illinois Center for Orthopaedic Research and Education. Participants will be assigned to one of three groups: a control group receiving standard care, a group wearing semiconductor fabric sleeves, or a group wearing placebo sleeves without semiconductor material. The sleeves are worn post-operatively, with a leg sleeve worn for 4 weeks followed by a knee sleeve for 12 weeks, totaling 4 months of use. The intervention is delivered through these wearable devices, and the study compares their effects on recovery after surgery. During the study, participants will complete patient-reported outcome surveys and undergo clinical assessments including range of motion and effusion measurements up to one year after surgery. Researchers will monitor the functional progress and measure outcomes using validated tools to assess improvements. The total follow-up includes evaluations at one year to understand the longer-term effects of the sleeves on knee function after surgery.

Age: 16Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are evaluating the feasibility of a randomized trial comparing perioperative single-shot adductor canal block (ACB) with standard general anesthesia without regional block in children and adolescents aged 10 to 18 undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction. The study aims to determine if ACB improves quality of recovery as measured by the Quality of Recovery-15 questionnaire at several postoperative time points. Secondary questions include whether ACB reduces opioid use, shortens post-anesthetic care unit stay, improves pain scores, and increases patient satisfaction. Participants will be randomly assigned to receive either a single-shot ACB with ropivacaine and dexmedetomidine after induction of general anesthesia or no nerve block, with all other care standardized between groups. The nerve block is performed under ultrasound guidance. Patients in the non-block group will have a dressing placed to maintain blinding. Follow-up visits occur at postoperative days 2, 14, and 42. During the study, participants and caregivers will complete the Quality of Recovery-15 questionnaire and pain rating scales on the day of surgery and at follow-up calls or clinic visits. Satisfaction ratings will be collected at postoperative day 42 using a 5-item scale. Researchers will also monitor opioid consumption, post-anesthetic care unit time, and any hospital admissions until day 42. Enrollment feasibility will be assessed based on recruitment rates over a 12-month period.

Age: 10Years - 18YearsAll GendersPhase 3
1 location
A

Actively Recruiting

Researchers are evaluating two approaches to rehabilitation following anterior cruciate ligament (ACL) reconstruction in young patients aged 15 to 21 years. The study compares Rehabilitation with Exercise and Psychological Support (REPS), which integrates exercise with psychological guidance, to standard rehabilitation without specialized psychological support. This pilot randomized controlled trial aims to see if REPS improves psychological readiness and knee function more than standard care during recovery. Participants will be randomly assigned to one of two groups. Both groups will follow standard exercise protocols for ACL reconstruction using bone-patellar tendon-bone or quadriceps tendon autografts, with optional additional therapies like electrical stimulation or manual therapy. The REPS group will receive extra psychological support through trained physical therapists and patient training videos focusing on mental skills and recovery mindset. All participants will watch group-specific videos and receive exercise guidance via an online platform. Participants will attend four study visits over six months: one before surgery and three during follow-up after surgery. Assessments include psychological readiness for sport, fear of movement, knee function, pain, range of motion, and strength tests at various time points before and after surgery. Researchers will also monitor the feasibility and acceptance of REPS, collecting questionnaires about empathy and therapeutic alliance. The study follows participants for six months post-surgery to evaluate outcomes.

Age: 15Years - 21YearsAll GendersPhase Not Applicable
1 location
A

Actively Recruiting

This trial studies adults with anterior cruciate ligament (ACL) rupture who need reconstructive surgery. It compares two types of screws used for fixing the graft during ACL reconstruction: a human allogeneic cortical bone screw called Shark Screw ACL and a conventional biocomposite screw (Mecta). The goal is to see if the bone screw reduces bone tunnel widening and lowers the rate of graft re-rupture. Knee function scores before and after surgery are also recorded to assess outcomes. Participants undergo ACL reconstruction with either the allogeneic bone screw or the biocomposite screw. The surgical technique is the same for both groups, including arthroscopic confirmation of diagnosis, tendon preparation, bone tunnel creation, graft insertion, and fixation with the assigned interference screw. The tibial bone tunnel is filled with cancellous chips, and graft stability is checked before wound closure. Participants have MRIs before surgery, within 3 days after surgery, and at 6, 12, and 24 months post-surgery. CT scans are done immediately after surgery, and at 6 and 24 months. Knee scores (IKDC, KOOS, Lysholm, Tegner) are collected before surgery and at 6, 12, and 24 months. The study measures bone tunnel widening in millimeters over time and evaluates graft incorporation, safety, and knee function. Total participation lasts 24 months after surgery.

Age: 18Years +All GendersPhase Not Applicable
1 location
A

Actively Recruiting

Researchers are studying patients undergoing surgical reconstruction of the anterior cruciate ligament (ACL) to better understand the factors that influence clinical outcomes after surgery. The study aims to analyze various patient features and clinical-functional statuses to identify elements that may help optimize treatment results in the future. It involves long-term follow-up assessments to gather data on patients' knee stability and functional symptoms. Patients will receive surgical ACL reconstruction and be monitored before the surgery and then at 6 months, 1 year, 2 years, and 5 years after the operation. These follow-ups will include clinical visits or telephone interviews. The study uses an innovative device with inertial sensors to measure knee laxity objectively, alongside several clinical scores such as IKDC, SF12, Marxs, Koos, Tegner, and VAS for pain and overall health. During each evaluation, patients will complete questionnaires to report functional symptoms, and their knee joint stability will be medically examined. The study will also record the time it takes for patients to return to work and sports, their satisfaction levels, any adverse events, treatment failures, and additional interventions on the same knee. The primary outcome is knee laxity measured at 5 years, with secondary outcomes including multiple clinical scores to assess overall function and pain.

Age: 18Years - 60YearsAll Genders
1 location
A

Actively Recruiting

Researchers are investigating two surgical techniques used alongside anterior cruciate ligament (ACL) reconstruction to address injuries involving the anterolateral ligament (ALL), which can increase knee instability. The study aims to compare the long-term graft survival and functional outcomes of the ALL reconstruction technique versus the modified Lemaire lateral extra-articular tenodesis (LET) technique over a minimum follow-up of two years. This trial responds to the need for evidence on which technique may provide better results for patients with ACL injuries who have risk factors such as participation in pivot sports and significant rotational knee laxity. Participants will receive ACL reconstruction with hamstring tendons combined with either the ALL reconstruction technique, which uses a gracilis tendon through the femur tunnel of the ACL graft fixed to the tibia, or the modified Lemaire LET technique, which uses a fascia lata strip attached near the knee and fixed through the femur tunnel of the ACL graft. The choice of technique is assigned randomly to compare these two approaches directly. Both procedures are performed during surgery to provide additional knee stability. During the study, participants will be monitored for graft rupture rates at 24 months after surgery, which is the main outcome measure. Additional assessments include the International Knee Documentation Committee (IKDC) score before surgery and at 6, 12, and 24 months afterward, as well as tracking any complications at multiple timepoints including immediately post-operation and during follow-up visits. The study lasts at least two years with regular evaluations to measure knee function and safety of the procedures.

Age: 18Years - 50YearsAll GendersPhase Not Applicable
1 location
A

Actively Recruiting

Researchers are evaluating knee joint stability, functional capacity, postural control, muscle activation, and muscle strength in patients with anterior cruciate ligament (ACL) injuries. This study compares two surgical techniques: conventional ACL reconstruction alone and ACL reconstruction combined with anterolateral ligament (ALL) reconstruction. Patients aged 18 to 50 years with unilateral ACL injuries will be included and followed through rehabilitation for up to nine months. Participants will be randomly assigned to one of two groups. Group 1 will undergo conventional ACL reconstruction using quadruple flexor tendons (semitendinosus and gracilis) performed with videoarthroscopy, followed by conventional physiotherapy including manual therapy, physical resources, kinesiotherapy, and isokinetic exercises. Group 2 will receive the same conventional ACL reconstruction plus ALL reconstruction using a similar surgical approach and graft preparation, followed by the same physiotherapy rehabilitation. Both groups will be evaluated before and after surgery. Throughout the study, participants will be assessed on articular range of motion, functional capacity, and isometric muscle strength at preoperative and multiple postoperative timepoints (5, 15, 30, 60, and 120 days). Secondary assessments include gait analysis, functional tests, postural control, and muscle activation measured by surface electromyography at similar intervals. The study is double-blinded and randomized, with ongoing monitoring during rehabilitation to compare outcomes between the two surgical methods.

Age: 18Years - 50YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of a single injection of mesenchymal stromal cells taken from a patient's own infrapatellar fat pad during anterior cruciate ligament (ACL) reconstruction surgery. This pilot clinical study is designed as a prospective, open-label, single-arm trial focusing on patients undergoing ACL reconstruction with a patellar tendon autograft. The study seeks to understand how these cells may impact recovery following surgery. Each participant will receive one intra-articular injection of autologous mesenchymal stromal cells about 21 days after their ACL reconstruction surgery. These cells are collected during the surgery, cultured, modified, and prepared to contain 50 million cells in a 1.5 ml dose. This treatment is administered in a single clinic visit following the surgical procedure. Participants will be monitored through several follow-up visits up to 6 months after surgery. Assessments include tracking treatment-related adverse events, knee function, pain, swelling, and time taken to return to sports activities. Evaluations occur preoperatively and at 6 weeks, 3.5 months, and 6 months postoperatively to measure the study's outcomes and monitor safety throughout the study period.

Age: 18Years +All GendersPhase 1
1 location
A

Actively Recruiting

This research aims to evaluate clinical practice in anterior cruciate ligament (ACL) revision surgery across multiple centers in France. Led by the French Arthroscopy Society and sponsored by the Centre Hospitalier Universitaire de Saint Etienne, the study focuses on collecting epidemiological, morphological, operative data, as well as clinical and functional outcomes and surgical complication rates in patients undergoing ACL revision surgery. Patients who have had an ACL revision surgery, which involves replacing the ACL graft with a new one, will be included. Data collection includes questionnaires such as the Anterior Cruciate Ligament Return to Sport and Injury (ACL-RSI), Tegner Activity Scale (TAS), Simple Knee Value (SKV), and International Knee Documentation Committee (IKDC) scores at 0, 6, 12, and 24 months. Medical record data including surgical details, complications, and functional outcomes will also be gathered. Participants will complete the listed questionnaires multiple times over two years to assess knee function and activity levels. Researchers will monitor surgical complications from the time of surgery up to two months. The study's primary measurements include functional scores related to knee performance and return to sport, with follow-up assessments extending to 24 months after surgery.

Age: 18Years +All Genders
1 location

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