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37 active trials for Anterior Cruciate Ligament Injuries

Supervised vs. Unsupervised Pre-habilitation for ACL Tears

Although the success of physical therapy following surgery has been well-documented and validated in patients undergoing Anterior Cruciate Ligament Reconstruction (ACLR) procedures, more recent studies have demonstrated that patient outcomes are the most favorable when surgery is delayed approximately 4 weeks until after the patient has completed a preoperative physical therapy program, or "pre-habilitation." The ultimate goal of pre-habilitation is to regain full range of motion in the knee and reach approximately 80% of pre-injury quadricep strength. However, extra physical therapy can stress both time and resources. Thus, we propose a home-based, self-guided pre-habilitation program. We hypothesize that patients participating in self-guided pre-habilitation will experience the same benefits as patients in a traditional office-based physical therapy program.

Start: February 2021

Prolonged Preoperative Rehabilitation in ACL Rupture.

Rupture of the anterior cruciate ligament is a serious and common injury. In young athletes, surgical reconstruction of the anterior cruciate ligament by autograft with hamstrings or patellar ligament is widely used. Despite relatively standardized medical, surgical, and paramedical management, the results after ACL ligamentoplasty are not entirely satisfactory in term of return to sport. Recovery of the quadriceps strength is recognized as one of the decision-making criteria allowing the return to sport; however, significant muscle deficits are frequent at the time of return to sport. If the postoperative management is well codified, focused on muscle strengthening and neuromuscular retraining, some studies have addressed the value of preoperative rehabilitation, and recommend a good preoperative muscular recovery of knee extensors and flexors, to obtain better postoperative results at the stage of the return to sports. These results suggest that preoperative quadriceps strength should be considered as a predictor of the athletes' ability to return to sport activities. It is estimated that around 10 to 30% of patients with preoperative deficits and could benefit from additional rehabilitation. It can then be assumed that if the preoperative deficit is smaller, the postoperative deficit will also be smaller. This is the challenge of preoperative rehabilitation. There are a few studies on preoperative rehabilitation which allow a gain in strength of knee extensors and flexors. However, the rehabilitation protocols applied to patients highly varied and there is no consensus on one protocol. The potential improvement is in the range of 10 to 20%. The hypothesis of the study is that an optimal recovery of the strength of the preoperative knee extensors and flexors would reduce the postoperative deficit, thus improving the return to sport. In the absence of reliable information on the frequency of muscle weakness in preoperative patients, we will conduct a preliminary study to obtain these data as well as the potential gain in strength with our preoperative rehabilitation protocol.

Start: June 2021

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Background: Post-traumatic knee osteoarthritis (PTOA) is a leading cause of medical separation from military service. Anterior cruciate ligament injury and surgical reconstruction (ACLR) incurs a high PTOA risk and is an ideal model for evaluating PTOA prevention strategies. Aberrant gait biomechanics are a primary contributor to PTOA development and are attributable in part to quadriceps muscle dysfunction. Vibration acutely improves quadriceps function and gait biomechanics in individuals with ACLR, but its effects on joint health and PTOA risk are unknown. Hypothesis/Objective: The objective of this study is to evaluate the effects of vibration embedded in ACLR rehabilitation on 1) quadriceps function, 2) gait biomechanics, 3) patient self-report outcomes, and 4) MRI indicators of knee joint health. The central hypothesis is that vibration will enhance gait biomechanics consistent with reduced PTOA risk and that whole body vibration (WBV) delivered by a commercial device and local muscle vibration (LMV) delivered by a prototype device will produce equivalent improvements in the study outcomes. The rationale for the hypothesis is that vibration will more effectively improve quadriceps function compared to standard rehabilitation, thus restoring normal gait biomechanics and mitigating declines in joint health. Specific Aim 1: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation (WBV and LMV) on quadriceps function. The investigators hypothesize that Vibration will produce superior outcomes (e.g. strength) compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes. Specific Aim 2: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation (WBV and LMV) on gait biomechanics linked to PTOA development. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes. Specific Aim 3: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation (WBV and LMV) on patient self-report outcomes. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that the outcomes will be similar between the WBV and LMV cohorts. Specific Aim 4: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation (WBV and LMV) on MRI indicators of knee joint health. The investigators hypothesize that cartilage composition (e.g. collagen, water, and proteoglycan content) will be poorer and PTOA incidence (MOAKS score) will be higher in the Standard cohort compared to both Vibration cohorts, but that WBV and LMV will produce similar outcomes. Study Design: The approach will be to recruit ACLR patients at the onset of rehabilitation and conduct a Phase II single-blind randomized controlled trial to compare the effects of standard ACLR rehabilitation (control) vs. standard rehabilitation that incorporates WBV or LMV on quadriceps function, gait biomechanics, patient self-report outcomes, cartilage composition, and PTOA incidence over the first year post-ACLR. Impact: The proposed work will evaluate the effects of a novel rehabilitation approach (vibration) for preventing PTOA. PTOA is a leading cause of medical separation from military service, degrades quality of life, increases the risks of several comorbidities (e.g. obesity, depression, cardiovascular disease), and is a primary contributor to years of life lost due to disability. Improving rehabilitation of knee injuries is paramount for maintaining the combat readiness of the armed forces and preserving the health and well-being of Service members and Veterans, as well as millions of Americans who are at risk of PTOA. Vibration represents a promising approach to this important challenge. Furthermore, in addition to being cost-effective, the portable nature of the prototype LMV device could have substantial implications for military personnel and US citizens, particularly those with limited access to rehabilitation facilities. The proposed work represents the critical translational link between existing pre-clinical data and the clinical setting that is necessary to establish its efficacy and accelerate its development as a commercially available device.

Start: July 2021

Biologic Therapy to Prevent Osteoarthritis After ACL Injury

Anterior cruciate ligament (ACL) injuries are extremely common. On average, 50% of individuals suffering an ACL injury will develop radiographic osteoarthritis (OA) 10 to 20 years after injury. Unfortunately, ACL reconstruction does not prevent risk of future OA. Interleukin-1 (IL-1) levels in the human knee joint increase transiently after an ACL injury. In animal experiments, if interleukin-1 levels are increased in the joint, this alone causes arthritis to occur. Interleukin-1 receptor antagonist (IL-1Ra) is a naturally occurring inhibitor of IL-1. However, in ACL injuries the balance of these two proteins is disturbed transiently after injury, with the effects of IL-1 dominating this balance. In a large animal model of ACL injury, injection of IL-1Ra into the knee joint after ACL injury significantly decreased the amount of arthritis that was later observed.Thus, the investigators hypothesize that injection of IL-1 inhibitor (IL-1Ra) into the knee joint of patients suffering recent ACL injury will decrease the incidence of cartilage damage. After appropriate IRB approval, a total of 48 active patients will be randomized into one of three treatment groups. Group 1 will receive removal of the knee joint fluid (aspiration of hemarthrosis) using a needle and syringe within 1 week of injury. Following aspiration of the knee joint, an injection of 5 milliliters (mls) of sterile saline (as a placebo control) will be administered. In addition, a second knee aspiration procedure and an injection of 5mls of sterile saline into the injured knee joint will be performed at 10 days post-injury. Group 2 will receive aspiration of the knee hemarthrosis as described in group 1 as well as intra-articular administration of 150mg (~5mls) of anakinra (rhIL-1Ra) within 7 days of ACL injury. In addition, a second knee aspiration and injection of 5mls of sterile saline into the injured knee joint will be performed at 10 days post-injury. Group 3 patients will receive aspiration of the knee hemarthrosis and injection of anakinra as described in group 2 as well as a second intra-articular knee injection of anakinra (150mg, ~5mls) on post-injury day 10. Thus, all patients in this randomized placebo-controlled trial will undergo two injection procedures prior to surgery. Investigators will analyze subjects self-reported function and pain scores as well as urinary levels of cartilage breakdown products over time. Additionally, MRI studies will be used to compare MRI findings among patients in these 3 treatment groups. Urine samples will be obtain prior to surgery, at the time of surgery and at multiple time points after surgery (3, 6, 9, 12 and 24 months after surgery). Subjective outcome measure assessments (surveys) will be completed by participants prior to surgery and then again at 6, 9, 12 and 24 months post-operatively. MRI studies will be obtained at 1 year and 2 years following surgery. Additional, MRI studies at earlier time points are optional.

Start: May 2021

Feasibility of a RCT That Compares Immediate Versus Optional Delayed Surgical Repair After ACL Injury

Currently, most patients with an anterior cruciate ligament (ACL) injury undergo surgery. There is a general belief that surgical reconstruction is necessary to return to sport safely and to limit premature knee osteoarthrosis or additional meniscal damage. However, there is unsufficient scientific evidence for this belief. Moreover, several studies show that a reconstruction does not guarantee successful return to sports or the prevention of osteoarthritis or meniscal injuries at all. Therefore, an immediate surgery after an ACL injury is more and more questioned. The only qualitative RCT that exists (KANON trial) could not demonstrate that an immediate reconstruction is an added value (in terms of symptoms, knee function, activity level, osteoarthritis or incidental meniscal damage) compared to a conservative approach consisting of progressive rehabilitation and delayed surgery if there was persistent knee instability. In a future multicenter RCT the investigators want to 1) verify these results and 2) search for predictors that predict which patients from the conservative group do well without delayed surgery. This information is invaluable to physicians as it allows them to decide which treatment is best for the patient. Before performing a large, adequately-powered RCT that compares both treatment options, the investigators will run a pilot study that assesses the feasibility to recruit ACL patients for such RCT. This seems necessary, as many patients still believe that timely surgery is a prerequisite for restoring knee function, for returning to sports and for preventing cartilage degeneration. These preferences for surgery might affect recruitment and adherence to the protocol. Therefore, a pilot study will performed that demonstrates whether a large RCT is feasible with regard to 1) participant recruitment, 2) adherence to the treatment arm they were allocated to and 3) protocol feasibility. The findings of this pilot study will help deciding about progressing to a future definitive RCT.

Start: September 2020

Safe Options for ACL Recovery

The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.

Start: February 2020

Return to Sports After ACLR

Patients who were surgically treated with ACL reconstruction at a single clinic between 2013 and 2018 will be approached by a questionnaire regarding their return to sport after surgery. Questions will focus on the timepoint of the return, subsequent injuries, and the impact of the initial injury on the life of the patients. In addition, existing clinical data from the baseline visit and from the follow-up visits offered routinely to the patient will be used.

Start: April 2021

Better and Safer Return to Sport

A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.

Start: March 2019

Making Football Safer for Women: Implementing an Injury Prevention Program

The aim of this study is to determine how we can best support coaches to implement an injury prevention (IP) program (Prep-to-Play) in female community Australian Football. We will recruit at least 2,600 female community footballers aged > 14years from 15 different football leagues. We will train and support coaches to implement the IP program and evaluate the effects of the IP program on injuries across two football seasons.

Start: April 2021

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.

Start: March 2021

Deficit in Quadriceps Voluntary Activation After Anterior Cruciate Ligament Reconstruction: Roles of the "Learned Non-use" Paradigm and the Interhemispheric Inhibition

Anterior cruciate ligament (ACL) tear is mainly caused by sport injuries. 40% of injuries are attributed to noncontact mechanisms involving pivoting. Regaining quadriceps strength is a primary focus of patients pursuing a rehabilitation program after ACL reconstruction (ACLR). Unfortunately, despite rehabilitation programs aimed at reversing this muscle weakness, quadriceps strength deficits may persist for years. Moreover, this deficit leads to increased risk of sustaining another knee injury, and increased risk for developing posttraumatic osteoarthritis. At present, neither the optimal rehabilitative program nor the clinical and instrumental parameters to take into account at the time of return to activity have reached a consensus among clinicians. The investigators hypothesize that: a persistent deficit in voluntary activation, that is an inability to achieve complete activation of a muscle, is present after ACLR. this deficit in voluntary activation is associated with a phenomenon of "learned/acquired non-use" both in balance and during gait. This phenomenon will be demonstrated by investigating asymmetries in the recruitment of the injured lower limb in balance tests and during gait. the "learned/acquired non-use" paradigm is associated to asymmetries in the hemispheric cortical activity. This phenomenon will be investigated through transcranial magnetic stimulation. The primary endpoint is the demonstration that the quadriceps muscle weakness after ACLR may represent a case of "learned non-use". This behaviour looks automatic and unconscious, so that the adjective "acquired" seems preferable to "learned". It consists of the under recruitment of the impaired side, once healed, as a form of unconscious protection, which is adopted when the contralateral side may carry out the function. The secondary outcome is the investigation of the correlation among the deficits in voluntary activation, in balance tests, during gait, and in the neurophysiologic trials, with the clinical conditions of the patients. It is expected that the injured lower limb show a deficit in the activation of the quadriceps muscle with respect to the contralateral one and with respect to normative data. The impaired limb will present lower recruitment in balance tests and a deficit in power production during gait. The contralesional hemisphere will demonstrate higher interhemispheric inhibition, lower short-interval intracortical inhibition (SICI) and higher short-interval intracortical facilitation (SICF) with respect to the ipsilesional hemisphere. The evidence for an asymmetry between the two lower limbs would support the hypothesis that the "acquired non-use" paradigm has a role in the deficits following ACL lesions and that it is unspecific across asymmetric impairments, and independent of the underlying disease. Results from the present study will allow: the identification of clinical and instrumental criteria to guide the return-to-sport decision following ACLR. the estimate of the sample size for future experimental protocols and new rehabilitative programs.

Start: April 2021

Muscle Architecture and Anterior Cruciate Ligament

The aim of this study is to examine the effects of plyometric training on biceps femoris longus (BFl) and vastus lateralis (VL) muscle architecture in individuals with anterior cruciate ligament reconstruction (ACLR). Individuals will be randomly placed into training and control groups. Measurements of muscle architecture will be taken bilaterally from BFl and VL muscles by means of an ultrasound device. Functional performance will be evaluated with the International Knee Documentation Committee score and the single leg jump test. Following the initial evaluations, individuals in the training group will receive plyometric training. Evaluations of muscle architecture and functional performance will be taken again from the individuals in the training and control groups at the end of the 4th and 8th weeks. The received ultrasound images will be calculated through the MicroDicom software. In-group and between-group comparisons will be analyzed using the Statistical Package for the Social Sciences program and appropriate tests.

Start: February 2021

Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.

Start: April 2021

How to Best Treat Anterior Cruciate Ligament Injuries

The project is a pragmatic registry-based RCT aiming to investigate ACL injury treatment. Study results will help fill knowledge gaps, facilitate shared decision making and strengthen patient treatment. Included patients will be randomized to (1) early ACL surgery followed by rehabilitation or (2) active rehabilitation with optional delayed surgery if indicated. Randomization and data collection is conducted through the Norwegian National Knee Ligament Registry (NNKLR) which is a well established population based ACL registry. Participation is based on informed consent to participate in the NNKLR and the registry-based RCT. The study uses the platform and outcome measures of the NNKLR to collect and measure data. The data will be stored as usual in the NNKLR, but RCT specific data will be exported for analysis and stored inTjenester for sensitive data (TSD). Data collected in NNKLR are: patient data (age, height, weight, activity level, smoking-and snuff habits), knee injury data (injury data, injury mechanism, additional knee injury), treatment (non-operative or ACL reconstruction, reoperation), surgical details (operation date, antibiotics, anti-coagulants, graft type and size, approach for femoral tunnel, additional injury and additional surgical procedure) and patient reported knee function at baseline, 2, 5 and 10 years. Also, x-rays and MRIs will be imported for included patients and stored in TSD.

Start: March 2021

Training of Falling Techniques on Landing Mechanics

The overall purpose of this study is to quantify the effect and retention of one-week training of falling techniques on landing biomechanics associated with anterior cruciate ligament (ACL) loading compared to soft-landing techniques in young recreational athletes. The secondary purpose is to assess the safety of the training program. Aim 1: To quantify the effect of one-week training of falling techniques on landing biomechanics during forward, lateral, vertical, and diagonal landings compared to soft-landing techniques. We hypothesize that falling techniques will result in increased knee flexion angles and decreased landing forces, knee abduction and internal rotation angles, and knee moments for all landing directions compared to soft-landing techniques immediately after the training. Aim 2: To assess the retention effects of the falling techniques on landing biomechanics compared to soft landings. We hypothesize that the effects of falling techniques on ACL loading variables will be more highly retained compared to soft-landing techniques two weeks after the training. Aim 3: To identify the safety of the training program. We hypothesize that participants can complete the training without suffering minor, moderate, or major injuries, while occasional minor bruises might be observed.

Start: January 2022

Influence of Proprioceptive Reweighting Ability on Lower-limb Biomechanics During Functional Tasks

Anterior cruciate ligament (ACL) injuries are frequent in handball especially among young players. Recent investigations highlighted the implication of the central nervous system as a potential risk factor for ACL rupture. The ability to dynamically reweight proprioceptive signals according to postural conditions is crucial for balance control. The aim of this study is therefore to investigate the influence of proprioceptive reweighting on biomechanical determinants of ACL loads during functional tasks and unplanned side cutting manoeuvers.

Start: February 2021

Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

The primary objective is to create a multicenter registry which captures information relating to the perioperative anesthesia course and management of children undergoing anterior cruciate ligament reconstruction and to examine practice patterns and incidence of complications. Data from any single institution involved in this registry will be used for local safety and quality improvement efforts. In addition data from each institution can be compared to the information from the entire group of institutions participating in the project, thus providing a measure for comparison with national practice. The aggregate multi-institutional data set will be used to develop quality benchmarks for national safety and quality improvement efforts and best practice recommendation. We believe that this registry can also demonstrate how web based data collection can be used to evaluate clinical anesthesia outcomes for surgeries with a low incidence of critical events but with significant variability in medical management.

Start: December 2020

Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge. A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess. The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).

Start: November 2019

The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial

Anterior cruciate ligament (ACL) reconstruction is one of most commonly performed orthopaedic surgeries. Several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. Variability exists among patients in terms of hamstring size, and therefore the graft diameter. Recently there has been an increasing amount of literature correlating the hamstring graft diameter with the graft failure rate [1-4]. They concluded that graft exceeding 8mm in diameter is associated with a significant lower risk of graft failure. There has been study showing that Asian patients were indeed 'different' from the Caucasians. Ho et al published his findings on Singaporean patients showing that the median graft diameters for female and male patients were 7mm and 8mm respectively [5]. A retrospective review our patients undergoing ACL reconstruction in our department over the past 10 years has shown that the mean graft diameter was 7.8mm (range, 5.5-10mm). The conventional way of four-strand hamstring autograft is done by doubling both the semitendinosus and gracilis tendons to provide a quadrupled graft. Several techniques have been described to increase the size of the hamstring graft. One of those is the -strand hamstring graft, in which the longer semitendinosus tendon is tripled with the shorter gracilis tendon doubled to produce a 5-strand configuration. We hypothesized that the 5-strand hamstring graft would provide a graft of significantly larger diameter than the conventional quadrupled autograft.

Start: January 2021

Neuroplastic Mechanisms Underlying Augmented Neuromuscular Training

The purpose of this proposal is to determine the neural mechanisms of augmented neuromuscular training.

Start: June 2019