Clinical Utility & Gait Analysis of NextAR System AUS

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

This study titled "Does Personalised Soft Tissue Balance Data Improve Outcomes in Patients Undergoing Medially Stabilised Arthroplasty? A Prospective, Randomised Study Investigating the Clinical Utility of the NextAR navigation system (NextAR)" is a randomised, single blinded, prospective cohort study with the primary aim determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment. The aims of this study are: - To determine the clinical utility of the NextAR system data in providing soft tissue balance patterns to enable prosthesis implants to resemble more native knee alignment - To determine whether NextAR system data contributes to improving patient outcomes and knee kinematics following TKR surgery, by providing greater flexion range that is equivalent to native knee motion. - To assess clinical outcomes measured by standardised assessments, including radiographic evidence, the Forgotten Joint Score (FJS), the Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L) questionnaires. - Determining the kinematics of the replaced knee as measured by 3D gait analysis. According to study protocol, clinical evaluation is performed preoperatively and postoperatively at 6 weeks, 6 months, 1, and 2 years with the use of the Forgotten Joint Score (FJS), Oxford Knee Score (OKS), International Knee Documentation Committee (IKDC) and European Quality of Life Five Dimensions - Five Levels (EQ5D-5L). CT scan is performed preoperatively and at 6-weeks after surgery, while X-ray assessment is performed at baseline and at the 1-year follow up. ;

Study Design

Related Conditions & MeSH terms

Total Knee Arthroplasty

Clinical Trial Details

NCT number	NCT05863741
Study type	Observational
Source	Medacta International SA
Contact	Arianna Girardi
Phone	+41 91 696 60 60
Email	girardi@medacta.ch
Status	Recruiting
Phase
Start date	May 15, 2022
Completion date	May 2026

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04458480` - Effect of Fast Inpatient Rehabilitation After TKA
Completed	`NCT03286543` - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System	N/A
Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Recruiting	`NCT05391828` - Persona MC vs PS RCT With ROSA	N/A
Active, not recruiting	`NCT04850300` - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses	Phase 3
Completed	`NCT05635916` - Trial of Liposomal Bupivacaine for TKA	Phase 4
Enrolling by invitation	`NCT05130216` - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Withdrawn	`NCT02495805` - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty	N/A
Withdrawn	`NCT01511211` - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic	Phase 4
Completed	`NCT01616836` - Optimizing Pain and Rehabilitation After Knee Arthroplasty	Phase 3
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT00985920` - Topical Tranexamic Acid for Total Knee Arthroplasty	Phase 4
Completed	`NCT00761956` - A Study to Compare the NexGen CR and CR-Flex Knee Implants	N/A
Completed	`NCT03289247` - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty	N/A
Terminated	`NCT03316118` - US Guided GNB vs Saline Injection for TKA	Phase 4
Recruiting	`NCT05962970` - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty	N/A
Completed	`NCT03317834` - Navio With Total Knee Arthroplasty
Enrolling by invitation	`NCT06188091` - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Utility and Gait Analysis of NextAR System AUS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms