Anterior Cruciate Ligament (ACL) Injury

Explore anterior cruciate ligament injury research studies. All trials follow HIPAA and IRB compliance standards.

Search Bar & Filters

Found 164 Actively Recruiting clinical trials

Y

RECRUITING

Isolated ruptures of ACL (anterior cruciate ligament) are ligament injuries which lead to the most surgical interventions on the capsuloligamentous system of the knee. These ruptures can be proximal, central or distal. Treatment of patients with proximal lesions should be graded and should take into account the patient's symptoms (feeling of instability), physical examination data, amount of residual ligament, sport practice, practice level, interval time since the initial trauma, work requirements… Functional treatment can be reserved for low-demanding patients in whom the practice level is limited and tprogression risk to a functionally unstable knee less marked. In athletes, the risk of a new sprain must be explained and the patient will choose functional treatment or surgical treatment. Functional treatment is variable, combining the use of splints, rehabilitation, muscle strengthening. The healing time is three months. Wearing a splint has not proven its effectiveness in preventing progression to complete rupture when resuming sport activities. If instability is revealed, it is then necessary to move towards ACL reconstruction treatment. Surgical treatment generally involves ligamentoplasty at the expense of a knee tendon to replace the ruptured ACL. In the context of proximal ACL rupture, the patient can also be offered surgical repair of the ACL. There are numerous studies on ACL ligamentoplasties results but literature is poor on modern ACL repairs outcomes. Surgical repair of proximal rupture of ACL has experienced renewed interest in recent years thanks to the appearance of new fixing systems. Used in the 1980s, this technique was gradually abandoned in the mid-1980s following disappointing results for the benefit of autograft reconstruction techniques. Few studies exist in the literature on long-term ACL repair surgery follow-up. In this context, this study aims to describe the relapse rate at 5 years of patients operated for a proximal ACL tear.

18+ yearsAll Genders
1 location
A

RECRUITING

The goal of this clinical trial is to determine the effect of semiconductor sleeves on the treatment of Anterior Cruciate Ligament (ACL) or Anterior Cruciate Ligament and Meniscus (ACL+Meniscus) arthroscopic surgery. The effect of the sleeves will be analyzed through patient reported and clinically measured outcomes. The main questions it aims to answer are: * Do the semiconductor sleeves improve the functional outcomes compared to the placebo? * Will patients experience improved functional outcomes in a shorter period of time compared to the placebo? Researchers will compare semiconductor fabric sleeves to a placebo (a look-alike sleeve that contains no semiconductor material) to see if the semiconductor fabric better treats ACL and ACL+meniscus surgical patients. Participants will: * Wear semiconductor or placebo leg sleeve for 4 weeks and knee sleeve for the following 12 weeks * Complete patient reported outcome surveys

16-65 yearsAll GendersNA
1 location
A

RECRUITING

Anterior cruciate ligament (ACL) injuries are becoming increasingly common among children and adolescents as they are engaging in contact sports at younger ages, which may contribute to a higher incidence of musculoskeletal injuries. This heightened susceptibility could be attributed to increased joint flexibility and potential immaturity in musculoskeletal development, with ACL reconstruction (ACLR) being the primary treatment approach. Effective pain management in the early postoperative phase is crucial, as it significantly impacts the ability to start rehabilitation and return to sports activities. Despite approximately 200,000 adolescents undergoing ACLR annually, there are no established benchmarks for pain management in this population, and significant variability exists in pain management practices in pediatric ACL reconstruction. Regional nerve blocks, such as femoral nerve blocks (FNBs), adductor canal blocks (ACBs), and sciatic nerve blocks (SNBs) are integral components of multimodal analgesia. Recent research in the adult population has shown that multimodal analgesic strategies in arthroscopic surgeries can significantly reduce postoperative opioid consumption and improve quality of recovery. In 2000, following the creation and initial clinical use of a 9-item Quality of Recovery (QoR) score, some authors introduced the 40-item QoR-40 and the shorter QoR-15. The QoR-15 scale provides a comprehensive assessment of postoperative recovery, with scores ranging from 0 (very poor QoR) to 150 (excellent QoR). Since then, the QoR-15 has emerged as the most commonly reported measure of patient-assessed quality of recovery after surgery, validated in the adult population. The investigators plan to perform a prospective randomized controlled feasibility study comparing preoperative single-shot ACB to non-block in pediatric patients undergoing ambulatory arthroscopic ACL reconstruction. The investigators hypothesize that patients who received ACB preoperatively would have improved analgesia, fewer opioid-related adverse effects, greater patient satisfaction, and shorter PACU recovery times. Feasibility will be determined by enrollment rate, defined as the proportion of participants enrolled over the number of participants approached. We will declare feasibility if the enrollment rate is ≥ 80%.The primary clinical outcome variable is improvement in QoR-15 scores on POD2, POD14 and POD42.

10-18 yearsAll GendersPHASE3
1 location
A

RECRUITING

The objective of this study is to examine the efficacy of Rehabilitation with Exercise and Psychological Support (REPS), a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos. The central hypothesis is that REPS will facilitate better psychological response (Specific Aim 1) and knee function (Specific Aim 2) than Standard Rehabilitation after ACL reconstruction. The feasibility, acceptability, and fidelity of implementing REPS will be explored. This is a pilot randomized controlled trial of 60 patients with ACL reconstruction who receive REPS or Standard Rehabilitation. Study participants in both treatment arms will receive exercise per a standard rehabilitation protocol. Physical therapists providing the REPS intervention will receive didactic training in psychologically informed practice principles and REPS procedures, clinical application practice, and regular feedback from the study team. Study participants in REPS will receive training videos on psychosocial aspects of recovery and mental skills to improve the psychological response. Study visits will occur prior to surgery (baseline), immediately before the first rehabilitation visit post-surgery, 3 months post-surgery, and 6 months post-surgery. Study Aims Specific Aim 1. To examine the efficacy of REPS on psychological response after ACL reconstruction. Primary Hypothesis: Psychological readiness for sport, measured with the ACL Return to Sport after Injury (ACL-RSI) scale, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery. Secondary Hypothesis: Kinesiophobia, measured with the Tampa Scale for Kinesiophobia (TSK-11) questionnaire, will be lower in REPS than Standard Rehabilitation at 6 months post-surgery. Specific Aim 2. To examine the efficacy of REPS on knee function after ACL reconstruction. Hypothesis: Self-reported knee function, measured with the International Knee Documentation Committee (IKDC) subjective form, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery. Exploratory Aim. To assess the feasibility, acceptability, and fidelity of implementing REPS after ACL reconstruction. Research records will be used to assess the feasibility of REPS, and develop surveys for patients and clinicians will be used to assess the acceptability of REPS. In both treatment arms, patients will complete questionnaires that align with anticipated clinical changes in empathy (Consultation and Relational Empathy, CARE) and therapeutic alliance (Working Alliance Inventory-Short Revised, WAI-SR), and documentation templates will be used to record treatments and training for descriptive analysis of fidelity.

15-21 yearsAll GendersNA
1 location
A

RECRUITING

Rupture of the anterior cruciate ligament of the knee joint is a common (sports) injury in young adults . Depending on various patient-related factors, such an injury can be treated surgically or conservatively . Arthroscopic and anatomical reconstruction is currently considered the gold standard of surgical treatment. In this procedure, the torn anterior cruciate tendon will be replaced usually with the own semitendinosus ligament, the patellar ligament or the quadriceps tendon by inserting it through bone tunnels in the femur and tibia. However, the optimal technique for fixing the graft remains unclear. Until the replacement graft has healed, the suspension of the graft remains the weak point of the overall construct . The currently common procedures are fixation by means of interference screw in the bone tunnels and distal fixation using endobuttons. These fixation methods differ only insignificantly in clinical scores, stability, or failure rate . A frequent complication after reconstruction of the anterior cruciate ligament is secondary tunnel dilatation, which has been described in up to 84% of cases. The cause of this is not yet fully understood. Nakazato et al. cites a longer graft and an increased dorsolateral tibial slope. Taketomi makes the posterior tibial slope particularly responsible for tibial tunnel widening and describes that an osteolysis process occurs due to the penetration of synovial fluid into the space between the tendon and the tunnel . Moon et al. see a negative correlation between the length of the graft insertion and tunnel dilation. The widening of the bone tunnels seem not to induce instability, but complicates a follow-up operation, e.g. a new cruciate ligament plasty in the event of rerupture following new trauma. The often up to twice as large bone tunnels make it difficult to find sufficient bone tissue to create a new tunnel. If the already existing and enlarged tunnel is reused, there is a risk of inadequate fixation and lack of incorporation of the new graft. In the revision, a two-stage procedure is often necessary, especially in the case of pronounced widening of the bone tunnel. The group postulates that with a tunnel width \>14 mm, only a two-stage procedure is possible. In a first operation, the bone tunnel must be filled with autologous or similar, and only in a second session a new reconstruction of the anterior cruciate ligament can be attempted. the investigators are planning a prospective, randomized, controlled, single-blind and monocentric study with 2 parallel groups to investigate an alternative fixation method in cruciate ligament surgery. This involves a screw made from allogenic bone (Shark Screw ACL®; Surgebright GmbH, A-4040 Lichtenberg, Austria) in the form of an interference screw obtained from donor cortical bone. The insertion of this bone screw is identical to the usual interference screws. This type of osteosynthesis material has already proven in other forms in fracture treatment. The investigators have been using screws made from allogenic bone in a similar form for the treatment of scaphoid fractures for more than 4 years , Calcaneal fractures, corrective osteotomies, and arthrodesis with excellent success in everyday clinical practice. Treatment with an allogenic bone screw is compared with the current standard treatment with resorbable interference screw MectaScrew (composite), Medacta Int. Str. Regina 34, 6874 Castel San Pietro, Switzerland) in a control group. The aim is to include 80 patients who will be included in the study, i.e. 40 per group. Surgical method, treatment plan and follow up treatment do not differ. The main objective of the planned study is to analyze the dilation of the bone tunnels in the two groups. This will be done by means of magnetic resonance imaging (MRI) and computer tomography (CT) examinations (MRI preoperatively, postoperatively (within 3 days) and at 6, 12 and 24 months after surgery, CT postoperatively within 3 days and at 6 and 24 months after surgery). The bone tunnels are measured and the results of the two groups are compared to determine whether the allograft screw shows less bone tunnel dilation than the current standard treatment. An initial evaluation of the data and publication is planned after 12 months; the final evaluation and publication will take place after 24 months. The secondary objectives are to record the advantages and disadvantages of the allografts and to analyze their safety and effectiveness. In particular, the incorporation of the screws is to be assessed and classified. In order to better assess the outcome of the operation, clinical parameters will be recorded, and the two groups compared with each other. Furthermore, MRI will be analyzed for its informative value with regard to bone tunnel measurement. The null hypothesis is that the two surgical procedures (bone screw / biocomposite screw) do not differ in outcome. The alternative hypothesis is that the use of the human, allogenic cortical bone screw as a fixation element for anterior cruciate ligament reconstruction results in faster and, above all, better incorporation of the graft, with less widening of the bone tunnel. Based on the experience of the investigators with similar osteosynthesis material made from allogenic bone, it is to be expected that the bone tunnel will heal scare free. The investigators see the advantage of the proposed treatment particularly in its bone-sparing nature. It is to be expected that this will make possible revision easier and that a two-stage procedure will be necessary less often.

18+ yearsAll GendersNA
1 location
A

RECRUITING

The literature presents a number of studies on the reconstruction of the anterior cruciate ligament, as well as numerous registers, but the identification of factors and parameters determining the clinical outcomes remains largely debated. The study aims to offer new elements to analyze this treatment and potentially identify the factors responsible for the outcomes and the factors useful to optimize the clinical outcome in the future. In fact, in addition to collect patient data in terms of features and clinical-functional status, objective data will be documented and correlated. In particular the quantification of knee laxity will be performed using an innovative device based on the use of inertial sensors (a methodology recently developed and already validated at the Istituto Ortopedico Rizzoli). The study is intended to include all patients who will undergo surgical reconstruction of the anterior cruciate ligament (ACL). These patients will be followed and evaluated preoperatively, at 6 months and at 1, 2 and 5 years after surgery during a clinical visit or a telephone interview. Such evaluations will include the submission of questionnaires to determine the patient's functional symptoms and also knee joint assessment during a medical examination to quantify the knee joint stability. Moreover, the following clinical scores will be adopted: IKDC-subjective, IKDC-objective, SF12, Marxs, Koos, Tegner, VAS for pain assessment, EQ-VAS for overall health status assessment. Also it will be recorded the lapse of time for returning to work and sports, the degree of patient satisfaction,the adverse events, the failures and any new treatments on the same site.

18-60 yearsAll Genders
1 location
A

RECRUITING

Anterior cruciate ligament repair (ACLR) is a surgical procedure of the knee associated with moderate to severe postoperative pain lasting beyond 24 hours following surgery. Provision of adequate postoperative analgesia is a prerequisite for performing this procedure on outpatient basis. By virtue of their analgesic effects, peripheral nerve blocks (PNBs), such as adductor canal block (ACB), have thus become part of the care standard for this surgical procedure. Though ACB provides effective pain relief, the duration of analgesia associated with this block is limited to eight hours postoperatively. As a result, patients having outpatient ACLR may experience severe pain following discharge, require additional opioid analgesics to control their pain, and even visit the emergency department for acute pain management. Consequently, perioperative care for the young outpatient population undergoing this procedure is an area where improvement is needed. Mixing adjuncts with local anesthetics can prolong the duration of analgesia of PNBs; both dexmedetomidine and dexamethasone have been shown to effectively extend the duration of PNB analgesia by 60% and 80% hours, respectively. The use of dexamethasone is wide spread, and dexmedetomidine is progressively gaining popularity. At Toronto Western Hospital, the use of adjuncts is left to the discretion of the anesthesiologists administering PNB; and dexamethasone is occasionally used to prolong block duration. The alternative approach to prolonging block duration is using ambulatory ACB catheters, but this is an expensive option that is applicable to select patients, and it is not available at the TWH. Importantly, these adjuncts seem to exert their effect through independent mechanisms; thus there may be an advantage to combining adjuncts together. Further prolongation of the duration of analgesia is desirable, as the prolongation of block duration associated with each of these two adjuncts, alone, falls short of the duration of worst postoperative pain following ACLR. Consequently, the investigators aimed to explore whether the combination of these two adjuncts offers an incremental benefit over either of them alone, by examining their potential additive or synergistic effect. This randomized controlled trial compares the effect of using perineural dexamethasone, dexmedetomidine, and their combination to Control on the duration of postoperative analgesia in patients having ambulatory ACLR with ACB.

18-50 yearsAll GendersPHASE4
1 location
A

RECRUITING

Anterior cruciate ligament (ACL) tears are associated with concomitant lesions of the anterolateral ligament (ALL), which increase rotatory instability of the knee. If untreated, ALL insufficiency can compromise the results of ACL reconstruction, with higher risk of iterative ACL tear or additional meniscal lesion. Several surgical techniques have been described to reconstruct the ALL. Indications are increasingly frequent and actually, consensus being young patients, patients practising pivot sports, significant rotational laxity on clinical examination with a positive pivot shift test, or in cases of iterative surgery. To date, the two most popular techniques are the Lemaire technique (use of a fascia lata strip) and LAL reconstruction plasty (use of part of an accessory hamstring tendon). The older Lemaire procedure, popularized in the 1980s has proved its efficiency in terms of biomechanics, safety and reproducibility. More recently, following a new, precise anatomical description, anterolateral ligament plasty (ALL) has been developed, which is intended to be more anatomical than Lemaire's technique, but whose clinical superiority has not yet been demonstrated. Both techniques are currently used in our department, with the choice of technique left to the surgeon's discretion. To date, no randomized prospective study has demonstrated the clinical superiority of one technique over the other with a long term follow up. The aim of this study was to compare graft survival of ALL reconstruction versus modified Lemaire LET in combination with ACL reconstruction with a minimum follow up of 2 years. Secondary aim was to compare functional outcomes between both groups.

18-50 yearsAll GendersNA
1 location
A

RECRUITING

This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.

18+ yearsAll GendersPHASE1
1 location
A

RECRUITING

This is a national multicentric study led by the French Arthroscopy Society (SFA) evaluating clinical practice in anterior cruciate ligament (ACL) revision surgery (epidemiological data, morphological data, operative data, clinical and functional outcomes, and surgical complication rates).

18+ yearsAll Genders
1 location

1-10 of 164

1