Clinical Research Directory

Do Patients With ACL Tears Demonstrate Weakness of the Soleus Muscle?

The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are: * Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (\>10%) * Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants? * Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.

Clinical-randomized Trial of the Effect of Rehabilitation Therapy Using Strength and Blood Flow Restriction Training on Muscular Fitness and Regeneration After Anterior Cruciate Ligament Reconstruction

With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.

Description of Return to Sport in Amateur Athletes Who Underwent Several Functional Tests (K-STARTS, Vertical Jumps and Soleus Muscle Strength) After Initial ACL Reconstruction

ACL injuries are incapacitating for both professional and amateur athletes, with long-term repercussions on performance and return to sport (RTS). Surgical reconstruction of the ACL is the main treatment option. Despite this, recurrence rates are high. Half of all recurrences occur within 8 months of reconstruction, and 70% within the first 6 months after RTS. Decision to RTS is therefore an important one, as returning too early can increase the risk of recurrence, while returning too late delays a return to pre-injury performance levels. As described by the Bern Consensus, RTS consists of three phases : * Phase 1: Return to participation (RTp) * Phase 2: Return to sport (RTS) * Phase 3: Return to performance (RTP) RTS decision must be based on multiple factors, including psychological, athletic and functional components, as well as specific nature of the patient's activities. However, few individual tests have been associated with a specific level of RTS. Furthermore, the majority of studies rely on subjective and non-objective assessments to determine whether the athlete has returned to their pre-injury level. It would therefore be relevant to study the RTS time of patients who have performed a combination of several objective functional tests whose results could be complementary, in particular the K-STARTS, the CMJ, the DJ and the measurement of soleus muscle strength.

Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture

The goal of this interventional study is to measure medial vastus inhibition and associate it with AMI classification in patients with ACL rupture. The main question it aims to answer is: Is there a correlation between AMI classification and clinical assessment after ACL rupture ? Participants will undergo surface EMG and Myotonometry.

Comparison of Arthrogenic Muscle Inhibition (AMI) After ACL Reconstruction in Patients With Conventional Rehabilitation or Conventional Rehabilitation Combined With Digital Therapy

Traumatic injury to the knee joint, such as rupture of the anterior cruciate ligament (ACL), can compromise the voluntary activation capacity of the quadriceps despite the anatomical integrity of the nerve and muscle structures responsible for contraction. This phenomenon is commonly known as 'arthrogenic muscle inhibition' (AMI). AMI is a major limiting factor in recovery and rehabilitation after ACL rupture, and a potential cause of functional disability if left undiagnosed and untreated. Traditional rehabilitation protocols for ACL reconstruction do not adequately address the underlying neuromuscular deficits caused by AMI, leading to sub-optimal recovery and prolonged rehabilitation. Furthermore, patient adherence to these protocols, outside of supervised settings, is variable and often poor, which can further delay recovery Recent advances in digital health technologies offer new ways of improving rehabilitation outcomes. Numerous studies highlight the effectiveness of digital therapies in the form of mobile applications in improving patient engagement and compliance with rehabilitation protocols. In addition, evidence suggests that the integration of these technologies enables faster recovery of muscle function, reduces pain levels, may reduce complications such as Cyclops syndrome and improves overall patient satisfaction with rehabilitation. Healing has developed a digital therapy called DOCT'UP® which, in addition to physiotherapy sessions, offers support programmes for patients following ACL reconstruction. These programmes include self-education exercises to be carried out at home, some of which specifically target the AMI phenomenon. DOCT'UP® digital therapy has already been used in rehabilitation after ACL reconstruction, with results at 3 weeks on quadriceps activation and post-operative pain, as well as at 1 year on Cyclops syndrome. Given the limitations of current rehabilitation practices in the context of AMI and the potential of the DOCT'UP® application, there is a clear need to scientifically assess whether the DOCT'UP® application can effectively improve the results of rehabilitation on AMI after ACL reconstruction. This is why the sponsor wishes to set up this Clinical Investigation.

Optimizing Graft Selection for ACL Reconstruction

Purpose: To investigate the differences between the three most common methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for the individual patient. Main research area: ¨ Sports Orthopedic Surgical research. State of the art: Every year in Denmark 2500 patients receive surgical reconstruction surgery to replace a ruptured ACL. Many patients experience a decline in knee function and 4-12% suffer a new ACL rupture within 5 years. According to data from the Danish ACL register, three methods of reconstruction are most prevalent, but with large variation between hospitals. This indicates lack of consensus on optimal surgical procedure. Design: Assessor-blinded randomized controlled study. 150 patients aged 18-40 with ruptured ACL are allocated to reconstruction with tendon(s) harvested from either the semitendinosus and gracilis, or the patella tendon, or the quadriceps tendon. Patient follow-up will be conducted preoperatively and 1, 6, 12, 24 months postoperatively. Primary technologies and outcomes: * Patient-reported knee-joint function, quality of life and donor-site morbidity is obtained with standardized questionnaires. Primary outcome is subjective knee function with the International Knee Documentation Committee evaluation form (IKDC) * Instrumented analysis of knee-joint coordination and neuromuscular control including 3-D motion capture and electromyography (EMG) during single leg jumps, landings and change-of-direction. Measurement of maximal explosive muscle power in knee extension and flexion. Primary outcome is relative difference between injured and healthy leg in rate of force development (RFD-LSI). * Standard clinical knee examination of range of motion and instrumented examination of knee-joint stability. * Magnetic Resonance Imaging (MRI) of the thigh muscles for examination of muscle morphology. The trial is designed for publication in three primary publications 1. \- Patient reported effect of graft choice in ACL reconstruction 2. \- Biomechanical effect of graft choice in ACL reconstruction 3. \- Clinical effect of graft choice in ACL reconstruction Additional secondary publications are in the pipeline. Reference to primary protocol and results will always be emphasized in secondary publication to ensure methodological transparency.

Non-Narcotic Pain Control After ACL Reconstruction

This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.

The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique

This clinical study investigates the outcomes of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques in patients requiring joint reconstruction. The study aims to assess the safety, efficacy, and functional improvements following these transplant procedures, utilizing donor tissues to restore joint function and alleviate pain in individuals with severe knee damage. Participants will undergo the transplantation procedure and be monitored for post-operative recovery, complications, and long-term outcomes, including joint stability and mobility. The study seeks to provide valuable insights into the effectiveness of these advanced surgical techniques for knee joint repair.

Microbiological Molecular Profile of the Knee Joint During Primary Reconstruction or Revision Surgery of the ACL

Anterior cruciate ligament (ACL) reconstructions are common surgical procedures, but a significant number fail for reasons that are not fully understood. Silent infections have been shown to cause failure after other orthopedic surgical procedures such as fracture fixation and joint replacement. Silent and subclinical infections, as well as disruptions in the knee joint microbiome, could therefore be potential causes of failure after ligament reconstruction. Traditional infection diagnostic methods (microbiological cultures) are often inadequate to detect these silent infections due to a lack of sensitivity. New molecular techniques such as high-throughput sequencing or NGS (next-generation sequencing) overcome this sensitivity problem and have proven effective in diagnosing polymicrobial infections. Increased sensitivity compared to traditional culture has been reported in numerous studies, with some demonstrating the ability of NGS to isolate the infectious organism(s) in up to 82% of culture-negative cases. These studies demonstrate the importance of advanced sequencing technologies for the diagnosis and management of infections after ACL reconstruction, offering promising prospects for improving clinical outcomes. At the Jean Mermoz Private Hospital, ACL reconstruction is performed using a graft that is previously immersed in vancomycin. In this context, this study will characterize the knee joint microbiome in the context of ACL reconstruction with a graft treated with antibiotics.

Conservative Treatment With Blood Flow Restriction in Patients With Total ACL Rupture. "Randomized Clinical Trial"

The goal of this randomised clinical trial is to evaluate the effects of exercise with blood flow restriction (BFR) in patients with a complete anterior cruciate ligament (ACL) rupture. The main questions it aims to answer are: 1. Does blood flow restriction adds any additional benefits to conservative treatment of the ACL? 2. Does bracing promotes spontaneous healing to the ACL Researchers will compare bracing and BFR to bracing and sham BFR to see if the intervention provides any additional benefits to the conservative management of this injury. Participants will: 1. Use a knee brace for 6 weeks with adjustments according to protocol 2. Follow and identical exercise plan with either BFR (intervention group) or BFR sham (control group) 3. Follow a home based exercise program.

Soft-tissue Quadriceps Autograft ACL-reconstruction in the Skeletally-immature vs. Hamstrings

To date, the use of the quadriceps tendon as an autograft option in primary paediatric Anterior Cruciate Ligament (ACL) reconstruction has not been well studied. The 2018 International Olympic Committee (IOC) Consensus Statement now outlines the quadriceps tendon as a possible autograft option. However, no Randomised Control Trial (RCT) has examined the efficacy of the quadriceps tendon autograft in primary paediatric ACL reconstruction compared to the historical "gold-standard" soft-tissue hamstring autograft in this population. In light of its evidence for favourable outcomes in the adult population, and the (albeit limited) evidence showing safety and promise in the paediatric population, clinical equipoise exists for assessing its impact on outcomes in paediatric patients at the index surgery. This is a parallel, international, multi-centre, blinded randomized controlled trial of 352 skeletally-immature (at the time of injury) patients (ages 10-18 years, inclusive) undergoing primary ACL reconstruction to compare the effect of autograft tendon choice (i.e. hamstring versus soft-tissue quadriceps) on the rates of ACL graft failure, return-to-sport, knee function, pain, health-related quality of life and health utility, psychological factors, range of motion and stability, and any other adverse events at 24 months.

Activation Failure of Knee Extensors After Anterior Cruciate Ligament Rupture Depending on the Contraction Mode

The primary objective of the study is to evaluate the impact of ACL injury and ACL reconstruction on voluntary activation during maximal voluntary contraction (measured by neurophysiological parameters) according to the contraction mode. The goal is to provide elements of knowledge to clinicians about the mechanisms of the activation failure depending on contraction mode, but also the resulting adapted clinical recommendations for conducting rehabilitation, and particularly for the use of different contraction modes. The main hypothesis is that activation failure is not equal according to the contraction mode during maximal voluntary contractions and neurophysiological parameters will be decreased in comparison with non-injured subjects. Secondary objectives are: * To analyze the evolution of neurophysiological parameters between sessions interspaced by several months according to the contraction mode. * To observe this time evolution depending on the treatment strategy chosen: rehabilitation or surgery plus rehabilitation.

The Effect of Cognitive-Based Neuromuscular Exercises on Reaction Time, Joint Position Sense, Proprioceptive Force Sense and Balance in Individuals Who Had Anterior Cruciate Ligament Surgery

The aim of this study is to investigate the effects of cognitive-based neuromuscular exercises on increased reaction time, decreased joint position sense, reduced proprioceptive force sense, and balance problems in individuals who have undergone surgery following anterior cruciate ligament (ACL) injuries. With the results obtained from the study, the investigators aim to provide a different perspective on rehabilitation methods applied after ACL reconstruction and contribute to the literature with objective and evidence-based information regarding the effects of cognitive-based neuromuscular exercises on sensorimotor, neuromuscular, and proprioceptive senses.

HemoNIRS: a Paradigm Shift in the Process of Musculoskeletal Rehabilitation of ACL Injuries in Cyclic Sports Athletes.

Muscle haemodynamics has so far been assessed using at most 2-3 near-infrared spectroscopy devices on isolated muscles and without correlating variables. At the same time, research on musculoskeletal pathologies is limited, and there are no studies that analyse the haemodynamic changes that occur when the anterior cruciate ligament (ACL) is injured and whether these changes last over time. The aim of the study is to monitor and evaluate the physiological changes produced by ACL injury on muscle performance using non-invasive near-infrared spectroscopy (NIRS) devices in trained athletes. This descriptive cross-sectional observational multicentre multicentre study, with Balearic Islands ethics committee IB 5585/24PI, will include males aged 18-65 years who have undergone ACL surgery, divided into 3 groups that: have an evolution of less than 6 months (ACL1), more than 2 years since the surgical intervention and are already practising normal physical-sports activities (ACL2) and the control group (CON) that has never suffered an ACL affectation to date. The 3 groups will perform an incremental intervallic test (4:1) on a cycloergometer or treadmill (according to the specificity of their sport), where different muscular haemodynamic variables will be assessed using 12-24 NIRS devices. The main study variables will be the muscular haemodynamic values of each muscle analysed and their correlation between them: muscular oxygen saturation, absolute capillary haemoglobin, loaded and unloaded with oxygen and relative muscular haemoglobin blood flow, loaded and unloaded with oxygen. Secondary variables will be heart rate, socio-demographic variables (age, toxic habits, injury and sports history) and subjective perception of effort (RPE-20).

Use of an Osteoconductive Scaffold in ACL-Reconstruction

Primary objective of the study is to evaluate efficacy of the surgical technique for ACL reconstruction using an osteoconductive scaffold, enlaced into the hamstring tendon autograft, compared to the traditional technique.