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Arthroplasty clinical trials

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NCT ID: NCT06354543 Recruiting - Arthroplasty Clinical Trials

Arthroplasty Cements Outcomes - A Post-market Follow-up

Start date: December 16, 2020
Phase:
Study type: Observational

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels. Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

NCT ID: NCT05606120 Recruiting - Arthroplasty Clinical Trials

H-35 CL TRAUMA Cemented Femoral Stem

Start date: December 1, 2022
Phase:
Study type: Observational

Study design: monocentric, retrospective, observational and post-market clinical study. Purpose: To demonstrate the safety and performance of CL TRAUMA femoral stem. The eligible study population is represented by the entire population that underwent a hip replacement with CL TRAUMA femoral stem from 2017 to 2020 at Azienda Ospedaliera di Padova (IT) in accordance with the indication for use of the product.

NCT ID: NCT05449327 Recruiting - Clinical trials for Venous Thromboembolism

Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.

NCT ID: NCT05190666 Recruiting - Clinical trials for Overweight and Obesity

Healthy Living After Knee Replacement

Start date: January 4, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

NCT ID: NCT04849884 Recruiting - Arthroplasty Clinical Trials

To Evaluate the Performance of the CORI™ KNEE TENSIONER as an Accessory to the CORI™ Surgical System.

Start date: February 10, 2022
Phase: N/A
Study type: Interventional

To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.

NCT ID: NCT04848896 Recruiting - Arthroplasty Clinical Trials

Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure

CORI RCT TKA
Start date: February 12, 2022
Phase: N/A
Study type: Interventional

Background: REAL INTELLIGENCE™ CORI™ (CORI Robotics) is a computer-assisted orthopaedic surgical navigation and burring system. CORI Robotics is designed to help surgeons in planning and executing certain types of knee surgery involving bone preparation. These types of surgery are called 'unicondylar knee arthroplasty' (UKA) and 'total knee arthroplasty' (TKA). Purpose: This study is being carried out to demonstrate the safety and effectiveness of the CORI Robotics in TKA procedure. The data collected will be used to demonstrate the safety and effectiveness of CORI and to register CORI in China mainland. The primary objective of this study is to evaluate the use of CORI in TKA procedure in achieving post-operative leg alignment as compared to procedures using conventional manual instruments. Research participants / locations: 140 research participants will be recruited from up to 8 sites in 3 countries globally (Australia, China Mainland, Hong Kong and New Zealand). There will be 70 patients having TKA using CORI and 70 patients having TKA using conventional procedure.

NCT ID: NCT04818840 Recruiting - Arthroplasty Clinical Trials

Evaluate the Performance of JOURNEY II CR in TKA Populations

JIICRTKA
Start date: March 3, 2022
Phase:
Study type: Observational

Background: The JOURNEY II CR Total Knee System consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II CR Total Knee System Objectives: Evaluate the performance of JOURNEY II CR TKA in APAC populations Evaluate the impact of patella resurfacing on the outcomes of JOURNEY II CR TKA Research participants / locations: A total of up to 480 knees' information will be collected in up to 15 sites in India, China mainland, Hong Kong, Singapore, Thailand and Japan There will be up to 240 knees for resurfaced patella group and up to 240 knees for un-resurfaced patella group.

NCT ID: NCT04728542 Recruiting - Arthroplasty Clinical Trials

A Post-market Observational ORIGIN® vs. VANGUARD® PS Clinical Study

Start date: March 25, 2021
Phase:
Study type: Observational

The study objective is to assess patient satisfaction after the surgery with a custom-made CE marked implant (ORIGIN®) versus off-the-shelf (VANGUARD PS) device, and to document the clinical and device performance outcomes of the ORIGIN System used in routine hospital practice in a large patient cohort treatment of total knee arthroplasty. The hypothesis is that patients receiving ORIGIN implants will experience a more natural feel of the prosthesis during the first year after the surgery compared to patients receiving VANGUARD implants (as measured with FJS), and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up. It is also supposed that the overall patient satisfaction is expected to be higher with ORIGIN PS than with VANGUARD PS treatment.

NCT ID: NCT04480320 Recruiting - Analgesia Clinical Trials

Sonography-guided Pericapsular Never Group Block for Hip Arthroplasty

QUASH
Start date: September 10, 2020
Phase: N/A
Study type: Interventional

In this study, the investigator will examine the efficacy of Pericapsular nerve group (PENG) block in hip arthroplasty as a post-operative pain management technique, study the analgesia, opioid-sparing effects and motor-blocking effects of the PENG block

NCT ID: NCT04318197 Recruiting - Arthroplasty Clinical Trials

Rehabilitation With Personalized Strategies According to Muscle Volume Before Knee Arthroplasty

REPERAGE
Start date: December 18, 2020
Phase: N/A
Study type: Interventional

Preoperative rehabilitation before total knee arthroplasty (TKA) has not been proven to be effective. Latest meta-analyzes do not find any improvement of motor performance during gait 6 months after surgery. However, most of the previous studies did not specifically target muscle atrophy to design rehabilitation protocol. Pre-operative muscle atrophy, although not systematic, is often observed. The preoperative muscles volumes of thigh muscles have been poorly identified and never used to adjust the pre operative rehabilitation strategy. As part of the "FOLLOWKNEE" (RHU) project, which attempts to implement a personalized management of TKA and its follow-up, this study wants to explore the potential effect of adapted treatment to improve muscle force and muscle volume before TKA.