Clinical Research Directory

A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy

This will be a prospective, randomized, noninferiority clinical trial comparing rehabilitation methods post-total knee arthroplasty (TKA). Population of interest is adult hip/knee clinic patients over age 18 who are indicated for unilateral primary total knee arthroplasty. All TKA patients are prescribed physical therapy (PT) for rehabilitation post-operatively. The investigators will compare this current treatment with a new, validated, wearable smart knee brace (FM2 Knee Brace) that can be used for rehabilitation post-TKA. Following enrollment in the study, the investigators will match and randomize participants into two cohorts (outpatient PT versus FM2 Knee Brace). Outpatient PT group will be prescribed routine six-week course of outpatient PT (no pool exercises, remainder at therapist's discretion) to start as soon as possible upon discharge. The FM2 Knee Brace group will complete device set up at pre-op visit and will be prescribed 3-4 exercises to complete at their discretion over six weeks. The investigators will collect measurements of knee flexion, extension, total arc of motion at pre-op visit and at 6-week, 3-month, and 1-year post-op visits. The investigators will also plan to record additional PROs, therapy compliance, and complication rates. The investigators will compare the two groups to test whether the new FM2 Knee Brace is noninferior to regular PT when recovering from TKA, and if the new technology could be an alternative to outpatient PT.

Triathlon All-Polyethylene Tibia Outcomes Study

The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR

The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.

Total Versus Robotic Assisted Unicompartmental Knee Replacement

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

How Many Dexamethasone Doses Should Be Given Perioperatively?

The purpose of this study is to determine the most efficient and safest dexamethasone dose given perioperatively during total knee arthroplasty that reduces postoperative option consumption and pain, improves postoperative nausea and vomiting, and minimizes postoperative complications

Impact of Dexamethasone Route on Pain and Inflammation in iPACK With ACB for Knee Arthroplasty

"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards: The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation. The main questions the study aims to answer are: Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery. Participants will: Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation

MRI Role in Knee Hemophilic Arthopathy

The aim of this study is to assess role of MRI in detecting synovial, cartilaginous , osseous abnormalities ، bleeding inside knee joint and to use a system for assessing HA as support for therapeutic regimes and for monitoring response to therapy .

Pre-operative Inspiratory Muscle Strength Training in Total Joint Surgery

The purpose of this research study is to evaluate effects of respiratory strengthening exercises on breathing function, in people who have orthopedic surgery. It is known that breathing function decreases for a few days after surgery. in In this study, we want to see if exercising before surgery strengthens the breathing muscles and improves recovery after surgery.

The Effect of Light Therapy on Post-Surgical Pain

This is a prospective randomized clinical trial study to investigate two main aspects. The first aspect is to investigate the efficacy exposure to green light emitting diode (GLED) in reducing postoperative opioid medications requirements by 20% as the primary outcome amongst patients scheduled for elective total knee replacement surgery (knee arthroplasty). The second aspect is to reduce postoperative pain by 30%, improve preoperative anxiety by 30%, and improve the quality of sleep pre and postoperatively by 30%. Seventy participants scheduled for elective unilateral primary total knee arthroplasty (total knee replacement) will be recruited from the pain clinic or from the orthopedic surgery clinics at Banner-University Medical Center by the pain or orthopedic physicians who are key personnel of this study. Once a participant is identified, he/she will meet with one of the research team members to explain the nature of the clinical trial and undergo a standard of care medical history gathering and baseline physical examinations. If the participant meets all the inclusion and have no exclusion criteria, he/she will be presented with a written consent in English to explain all the risk and benefits of this clinical trial. Once a participant signs a consent, he or she will be randomized by the study statistician, in a 1:1 ratio to either a GLED group (treatment) or white light-emitting diode (WLED) group (control). The participant will be trained on how to use the light device by one of the research team members. All participants will be exposed to either GLED or WLED for 8 weeks prior to surgery and two additional weeks after surgery.

Incidence and Risk Factors for Post-Anesthetic Morphine Titration in Recovery Room After Hip and Knee Arthroplasties

Despite the use of multimodal analgesia combining nerve block (NB) and systemic analgesia, intravenous (IV) morphine titration in the post-anesthetic care unit (PACU) after total hip (THA) and knee (TKA) arthroplasty is required to relieve early moderate-to-severe pain. Sedation occurrence during titration and a VAS score higher than 60/100mm are two independent risk factors for postoperative pain during hospitalization. The association of NB and multimodal analgesia constitutes the reference in evidence-based recommendations. An adductor or femoral triangle block, alone or associated with periarticular infiltration, is recommended during TKA. During THA, NB associated with surgical periarticular infiltration improves analgesia and rehabilitation This study aims to identify the incidence and risk factors of morphine titration in PACU after lower limb arthroplasty performed by 5 experienced surgeons and using a multimodal analgesic procedure

Total Knee Arthroplasty: Fast Track Protocol is the Future?

Fast-track total knee arthroplasty (TKA) is a well-established concept including optimized logistics and evidence-based treatment, focusing on minimizing surgical stress and improved post-operative recovery. The aim of this protocol is to compare the standard care and fast track total knee arthroplasties in terms of functional and subjective outcomes, hospital staying, number of transfusions and analgesic consumption.

Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Locomotor System

RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life.