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Replacement clinical trials

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NCT ID: NCT06371833 Not yet recruiting - Arthroplasty Clinical Trials

PRIMA EU Retrospective & Prospective

Start date: May 2024
Phase:
Study type: Observational

This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.

NCT ID: NCT06323980 Not yet recruiting - Arthroplasty Clinical Trials

INHANCE Stemless Reverse Shoulder IDE

Start date: September 30, 2024
Phase: N/A
Study type: Interventional

2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

NCT ID: NCT05971641 Not yet recruiting - Arthroplasty Clinical Trials

The Effect of Progressive Relaxation Exercises on Postoperative Pain

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

The indicators of patient recovery in the postoperative period include sleep, physical functionality, mental health, cognitive functionality, pain, and psychosocial functionality. This thesis aims to investigate the effects of progressive relaxation exercises on postoperative pain intensity, sleep quality, and recovery in patients undergoing total knee arthroplasty.This study, designed as a randomized controlled experimental study, will be conducted between September 1, 2023, and August 1, 2024, at ÇAYCUMA State Hospital in ZONGULDAK province, Turkey, among patients undergoing total knee arthroplasty. A total of 96 patients will be recruited based on the sample size calculated using G-power analysis. Through block randomization, 48 patients will be assigned to the intervention group and 48 patients to the control group. Data will be collected using the Numeric Rating Scale for pain, the Richard-Campbell Sleep Scale, a sleep tracker smart wristband to measure sleep quality and duration, the Postoperative Recovery Index, and a Patient Information Form.

NCT ID: NCT05824533 Terminated - Arthroplasty Clinical Trials

Difference in Patellar Tracking Before and After Journey II BCS Total Knee Arthroplasty, Evaluated With 4D CT Imaging

Start date: April 8, 2022
Phase: N/A
Study type: Interventional

The current proposal aims to investigate the patellar tracking in adult patients receiving Journey II Bi-Cruciate Stabilized (BCS) total knee arthroplasty (TKA) before and one year after surgery, positioned with the CORI Robotics System instrumentation. The hypothesis is that less change in patella tracking before and after surgery will lead to less anterior knee pain complaints. Patella tracking is investigated using 4Dimensional Computer Tomography (4D CT) imaging. Researchers will compare the group of participants that will receive a patella onlay button with the group that will not receive a patella onlay button with their TKA to see if there is a difference in motion and pain experienced by the participants.

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: NCT05332717 Completed - Clinical trials for Sleep Initiation and Maintenance Disorders

TKA Melatonin and Sleep Quality

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

This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.

NCT ID: NCT05030662 Enrolling by invitation - Knee Osteoarthritis Clinical Trials

Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to examine whether the effect of "hiking poles exercise" on lower extremity muscular strength, knee range of motion, and quality of life in elderly patients underwent total knee arthroplasty

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: NCT04822259 Withdrawn - Arthroplasty Clinical Trials

Evaluate the Performance of JOURNEY II CR and JOURNEY II BCS in TKA Populations

JIICRBCSTKA
Start date: August 28, 2022
Phase: N/A
Study type: Interventional

Background: The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM) The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM) Purpose: Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System Objectives: 1. Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations 2. Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR Research participants / locations: A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.