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45 active trials for Total Knee Arthroplasty

Effectiveness of a Community-based Multi-modal Tai Chi Rehabilitation Program for Patients After Total Knee Arthroplasty

The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.

Start: November 2018

BFRT vs Standard PT After Total Knee Arthroplasty

Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training. Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol. Primary Outcome Measures: Quadriceps Strength: dynamometry (hand held) Secondary Outcomes Measures: Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an ? of 0.05 and ? of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

Start: March 2021

Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: RCT

Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) has recently been reported to be effective in controlling pain in persistent chronic pain caused by joint surgery and arthritis. However, opioids are important drugs that still play a pivotal role in pain control after surgery. In this study, we want to investigate the difference of the result among patients who undego total knee arthroplasty (TKA), of the result of pain control after TKA from SNRI administration of duloxetine and opioid in two groups. We designed a randomized controlled study (RCT) for the effect of post-TKA pain control to determine whether SNRI is effective in controlling post-TKA pain compared to Opioid, and whether there is a difference in side effects.

Start: January 2021

Optimizing Physical Activity Outcomes After Total Knee Arthroplasty

Although total knee arthroplasty is an effective intervention for decreasing knee pain and improving physical function, physical activity levels remain low up to a year after surgery. This study will use mobile-health technology to deliver an intervention designed to improve physical activity behavior for Veterans recovering from total knee arthroplasty. The study will assess the effectiveness of using behavior-change intervention as a supplement to conventional rehabilitation to improve physical activity. The intervention will be delivered using home-based tablet computers for Veterans to have remote interaction with the researcher and real-time physical activity feedback from a wrist-worn activity sensor.

Start: November 2017

Dexmedetomidine as an Adjuvant for Femoral Nerve Block and Functional Recovery After Total Knee Arthroplasty

Femoral nerve block (FNB) is a first-line analgesic technique for multimodal analgesia after total knee arthroplasty (TKA). Recent studies and meta-analysis indicate that dexmedetomidine combined with local anesthetics for FNB can prolong the analgesic duration, improve the analgesic efficacy, inhibit local inflammatory response, and reduce narcotic consumption. The investigators hypothesize that dexmedetomidine combined with ropivacaine for FNB can also improve functional recovery in aged patients after TKA.

Start: November 2020

Postoperative Painful Chronicization After Knee Replacement Surgery : Exploratory Study of BDNF's Kinetics

Chronic pain is an extremely disabling disease. It is a major public health problem due to the lack of effective therapy. Chronic postoperative pain (CPOP) is defined by a painful symptomatology in the operated area unrelated to previous pain, present for more than 3 months, and without any link to surgical complication. The prevalence of chronicization of postoperative pain is 30% after total knee arthroplasty. Identification of clinical, biological and psychological profiles are crucial to prevent CPOP. A biologic factor, Brain Derived Neurotrophic Factor (BDNF) produced by a variety of cells is a key regulator of neuroplasticity. BDNF is increasingly studied in the mechanisms of cerebral sensitization and pain chronicization. The role of BDNF in pain of patients remains to be explored in a prospective study. The aim of this observational study is to compare the kinetics of BDNF after total knee arthroplasty in patients with and without CPOP. Patients will be included in the study at the preanesthetic consultation. Serum BDNF levels will be measured preoperatively, 48h postoperatively, 3 and 6 months after surgery.

Start: December 2020

Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.

Start: February 2021

Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented

Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant. Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population. Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants. Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence. We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.

Start: September 2021

Efficiency of Donepezil in Elderly Patients for Prevention of POCD Dysfunction

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.

Start: June 2020

Impact of Crutch Type on Gait and Functional Outcomes Post-knee Surgery

After knee surgery, patients might get crutches to help them move around while their knee is in recovery. Walking with crutches might cause discomfort in the upper body or lower body, since it changes the body's usual movement patterns. The present study is interested in understanding how different types of crutches affect recovery from knee surgery.

Start: January 2021

In Vivo Kinematics for Subjects With Smith & Nephew Journey II BCS TKA, Journey II CR TKA, Or Journey II XR TKA

The objective of this study is to determine and compare the in vivo kinematics and vibroarthrography (VAG) signals for subjects implanted with Journey II Bi-Cruciate Stabilized (BCS), CR (Cruciate Retaining), and Bi-Cruciate Retaining (XR) TKAs.

Start: October 2020

A Study to Evaluate the Outcomes of Cannabinoid (CBD) Roll-on Topical Stick in Primary Total Knee Arthroplasty

Total knee arthroplasty (TKA) is one the most common surgical treatments performed for end stage degenerative arthritis of the knee. More than 700,000 procedures are currently performed yearly in the United States. This procedure usually results in moderate-to-severe pain in the immediate post-operative period. Optimal pain control may allow early mobilization, accelerate rehabilitation, improve patient satisfaction, decrease length-of-stay, and optimize functional outcomes. The challenge, however, is to manage pain with alternative methods, reducing the role of opiate medications, which are highly addictive with myriad side effects. In this prospective randomized double-blinded controlled study, the investigators aim to evaluate the benefits of an over-the-counter (OTC) transdermal CBD preparation in patients undergoing primary total knee arthroplasty as a novel adjunct to the standard multi-modal analgesic regimen, to reduce postoperative pain and reduce the need for opiates after total knee arthroplasty.

Start: October 2020

Movement Pattern Biofeedback Training After Total Knee Arthroplasty

This research study explores the effects of movement pattern training using real-time biofeedback insoles after total knee arthroplasty. The purpose of this research study is to determine if the addition of a novel movement pattern training program (MOVE) to contemporary progressive rehabilitation leads to improved movement quality and physical function compared to contemporary progressive rehabilitation (CONTROL) alone.

Start: January 2018

Cemented vs Cementless in Bilateral TKA

To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Start: March 2020

Effect of Fast Inpatient Rehabilitation After TKA

Rehabilitation is an important part of the post-operative treatment after TKA by consensus. This study intends to analysis whether fast inpatient rehabilitation after TKA can improve knee joint or general function, and ultimately explore for effects and values of fast inpatient rehabilitation after TKA.

Start: September 2019

Compressive Stockings Therapy After TKA

Due to swelling after total knee arthroplasty, postoperative mobilization and training is impeded in addition to higher pain level in patients. With postoperative compressive stockings to prevent oedema, haematoma and postoperative pain we would like to investigate if compressive stockings reduce postoperative swelling and pain and furthermore improve mobilization and knee function. In this randomized controlled trial, 88 patients are randomized in two groups. One group receives postoperatively compressive stockings for a period of 6 weeks. The control group is treated without compressive stockings. The patients compressive stockings wearing compliance is controlled with a temperature sensitive sensor. The patients will be informed about the implantation of the sensor. Outcome measures are knee- calf- and ankle swelling in mm, pain, WOMAC and KSS score preoperatively and at 12 weeks, 12 months and 24 months.

Start: February 2019

PMCF Study of MPS-Flex® Knee System in TKA

The objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available MPS-Flex® Total Knee Joint Prostheses used in primary total knee arthroplasty (TKA).

Start: October 2020

Total Knee Arthroplasty Robot Assisted With MAKO™ Robotic System Compared to the Conventional Total Knee Arthroplasty by Mechanical Ancillary

For the total knee arthrorplasty (TKA), the placement of a prosthesis is delicate and the correct positioning of the implants determines the result of the surgery. Navigation has improved surgical accuracy but remains inadequate with nearly 20% malposition. In the early 2010s, robot-assisted surgery solutions were born. Amongst its offers, Stryker's MAKO™ system appears to be the most advanced and developed due to its precision and its flexibility of use during surgery. In this study, the investigators evaluate the placement of the total knee prosthesis with the MAKO™ system compared to the placement of the total knee prosthesis with a conventional mechanical system for TKA

Start: April 2018

Comparison of Surgical Glove Contamination During Total Knee Arthroplasty Procedure : a Randomized Controlled Trial

Total knee arthroplasty post-op surgical site infection rate about 0.5- 5% Pre-operative , perioperative and post-operative prevention are importance for reduce surgical site infection The prevention of surgical-site infections (SSIs) is an integral component of nosocomial infection control and a major priority in orthopedic surgery. Surgical wound contamination must be prevented to avoid patient colonisation by microorganisms during surgery. Surgical glove changing perioperative can reduce contamination and perforation rate Orthopedic surgery had found contamination rate about 20-28 % Joint replacement procedure found contamination rate about 38-67% of all orthopedic surgery 12% of gloves are contaminated after draping and 24% once patient installation is complete. We hypothesis that changing surgical glove during total knee arthroplasty can reduce contamination rate on surgical glove.

Start: July 2020

Comparison of TKAs Using Force Plate Analysis

The purpose of this study is to evaluate performance of two modern total knee arthroplasty designs using patient reported outcomes and force exhibited during various activities of daily living.

Start: October 2020