Clinical Research Directory

Effect of Remimazolam and Propofol on Postoperative Delirium

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.

Dual Implant Versus Single Implant Distal End of Femur

This research study is being conducted to examine the effect of two versus one fixation device for fixation of distal femur fractures.

Outpatient Floor Pedal Bike Utilization

The goals of this clinical trial are: to test the feasibility of identifying patients and getting patients the floor pedal bikes, to test how well floor pedal bikes help patients with lower body injuries heal, and to test methods of patient self-reported logs for home pedal bike use. Participants will be given a floor pedal bike at first post-operative appointment where weightbearing restrictions are lifted (weight-bearing as tolerated) along with instructions on utilization. Participants will be asked to complete patient reported outcome measure surveys at each follow-up visit.

ZNN Bactiguard Antegrade Femoral Nails PMCF Study

This is a multicenter, prospective, Post-market Clinical Follow-up (PMCF) Study on the ZNN Bactiguard Antegrade Femoral Nails. The objective of this study is to collect data confirming the safety, performance, and clinical benefit of the study device and instrumentation when used for the temporary internal fixation and stabilization of femoral fractures and osteotomies. This is a CE-marked device already available on the market and the aim of the study is to comply with the post-market surveillance requirements.

Comparison of EOSP Between Usg Guided S-FICB vs USG Guided PENG Block in Pts Undergoing Femur Fracture Surgery

To compare the immediate and postoperative analgesic efficacy of S-FICB and PENG block will be the objective. The use of ultrasonography in anesthesia has helped the anesthetist to see the nerve, needle and the distribution of the drug, thereby enhancing the chances of a favorable outcome of the nerve block. Grade A recommendation for an ultrasound guided approach to the peripheral nerve blocks is supported by level Ib evidence for a shortened time for the onset of sensory block, decreased performance time and lower drug doses10. Although individually both the blocks have been studied, there are only a handful of studies comparing both techniques under ultrasound guidance for making patient positioning for spinal anesthesia easy. And no local data is available comparing these blocks. So, we want to compare the analgesic efficacy of USG PENG block with USG S-FICB block in patients with fracture femur in reducing pain associated with positioning (sitting) for subarachnoid block, duration of analgesia, opioid sparing effect and complications. So that procedure with better analgesic efficacy and less complications will be included in our local guidelines as a part of multimodal analgesia.

Vastus Intermedius Dry Needling for Knee Stiffness Resulted From Surgically Managed Femoral Fractures With Open Reduction & Internal Fixation.

Orthopedic traumatic injuries are considered a major health epidemic, challenged by high morbidity, mortality, and socioeconomic burden. The management of traumatic orthopedic injuries is challenging and complex, with high resources utilization. Particularly, the prevalence of femoral fractures in Kuwait is 8.8%, being one of the most prevalent injuries. Open reduction and internal fixation (ORIF) is a common surgical procedure for the management of femoral fractures demonstrating successful outcome for allowing minimally invasive percutaneous plate osteosynthesis, early union of 93% to 100%, and low infection rate of only 0% to 2%. Yet, one of the major complications post ORIF is knee stiffness and reduced function, which brings many inconveniences to patients' daily lives, lead to disability, and could seriously threaten the functional activities of patients. The incidence of knee stiffness requiring surgical intervention is 14.5%. Particularly, the potential loss of knee flexion is 30 to 40 degrees, 13% of the patients failed to reach 90 degrees of knee flexion, and only 48% of patients reached \>120 degrees of flexion. Ultimately, knee stiffness in flexion forms a major issue in distal femoral fractures. Various reasons could explain such complication including intrinsic adhesions, fibrosis and shortening of the vastus intermedius muscle. There are various surgical procedures which could be used to manage knee stiffness. However, there is no consensus regarding the ideal approach and strategy with many postoperative complications including deep sepsis, quadricep tendon rupture, skin dehiscence and infection, delayed wound healing, patella fracture, lateral femoral condyle fracture and extension lag. In contrast, dry needling (DN) is a minimal invasive intervention for the management of musculoskeletal dysfunction, and it could be used to reduce the adhesion and fibrosis between the vastus intermedius and the femoral bone. However, there is limited research investigating the effect of DN on the vastus intermedius muscle after ORIF of the femoral fractures. The effectiveness of DN was explored for the management of various musculoskeletal conditions, and a systematic review addressing DN in the lower quarter concluded that DN is an effective procedure (Morihisa et a,., 2016). In ACL reconstruction, DN for the vastus medialis improved ROM at short-term and improved function at both short and long term. DN has been proposed as a useful addition to the rehabilitation of ACL reconstructed in reducing pain intensity, increasing knee flexion range, and modifying the mechanical properties of the quadriceps muscle during the late-stage of rehabilitation. DN has also altered the passive mechanical properties of the quadriceps muscle where decrement and resistance of the vastus medialis were significantly reduced. It is hypothesized that releasing the adhesions and fibrosis of the vastus intermedius could play an important role in managing knee stiffness post ORIF of the distal femur fractures. Therefore, the aim of this project is to identify the incidence rate and risk factors of knee stiffness resulted from surgically managed femoral fractures with open reduction and internal fixation in Kuwait, and to investigate the effect of DN on the vastus intermedius muscle in improving knee joint range of motion and function after ORIF of the distal femur using single blind randomized controlled trial (RCT).