Clinical Research Directory

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

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

INHANCE Stemless Reverse Shoulder IDE

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

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

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.

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.

Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA)

Direct Anterior Approach (DAA) is known to cause damage to the TFL during the surgical approach, the point of this study is to evaluate the impact between the severity of the per operative TFL damage and the functional short term results.

Triathlon Tritanium Cone Augments Outcomes Study

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon TS Total Knee System with Triathlon Tritanium Cone Augments for revision total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The revision rate of the Triathlon Tritanium Cone Augments is expected to be less than 2.8% for aseptic loosening of either the Femoral or the Tibial Cone Augments at 2 years postoperative.

Uncemented Tritanium Compared With Cemented Metal-backed Tibia Components in Total Knee Replacement

The optimal method of total knee replacement component fixation to the bone remains a challenge. The use of bone cement is considered the gold standard and is the preferred technique for most surgeons. However, uncemented fixation methods have been developed in an attempt to tackle problems that can be seen when cement is used. The cement-bone interlock can deform and degrade over the years and can lead to aseptic loosening, especially in young and active patients. A loosened prosthesis results in an impaired functioning and painful knee in daily life for which a revision of the prosthesis may be necessary. To prevent aseptic loosening and subsequent revision surgery, new methods of uncemented fixation have been developed. One of these methods is to use a highly porous metal called Tritanium®. It can improve the biologic fixation by resembling the characteristics of trabecular bone. It is expected that this surface aids bone ingrowth and to have similar or even better results concerning early fixation properties and long-term durability compared with cemented fixation. Excellent results using this highly porous Tritanium have been seen in total hip surgery already. This single-blinded, randomized clinical trial will assess clinical and radiological outcomes including Roentgen Stereophotogrammetry (RSA) measurements of a newly approved uncemented Triathlon Tritanium CR total knee prosthesis compared with a standard cemented Triathlon metal-backed CR total knee prosthesis (both by Stryker Orthopaedics). Two arms of each 35 patients will be included. The primary outcome measure will be prosthetic migration after two years of the uncemented Triathlon Tritanium CR Total Knee and the cemented Triathlon CR Total Knee by means of RSA. It is hypothesized that the new uncemented Tritanium prosthesis will perform at least equally good in terms of migration and clinical parameters compared with the standard cemented Triathlon. The secondary outcome measure will be long-term (10-year) survival based on the two-year migration patterns combined with clinical factors and radiographic aspects. In order to identify other clinical parameters besides the fixation of the prosthesis components, clinical scores and radiographic aspects will be correlated with the RSA outcome. The 10-year results will be used to verify the predicted long-term survival results.

PRIMA EU Retrospective & Prospective

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.

ORIGIN® vs. VANGUARD® PS Observational Study

The study objective is to assess patient satisfaction after the surgery with a patient match 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 Effect of Progressive Relaxation Exercises on Postoperative Pain

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.

A Randomized Controlled Trial of the Sagittal Alignment Difference Between Mako Robotic TKA and Manual TKA

As China transitions into an aging society, the proportion of the elderly population is escalating, with a corresponding rise in the number of patients with knee joint diseases. Total knee arthroplasty stands as an effective treatment for joint disorders, effectively reducing knee pain, restoring functionality, and enhancing quality of life. The objectives of total knee arthroplasty are to relieve pain, restore function, and ensure a long-lasting implant. In recent years, technological advancements have integrated robotic assistance into total knee arthroplasty (TKA), aiding surgeons in planning and executing more accurate surgical plans, significantly enhancing precision and post-operative outcomes. However, the Mako mechanical axis alignment demonstrated during the Mako robot-assisted TKA procedure does not correspond to the actual straightening of the lower limb, and discrepancies may exist in sagittal alignment between Mako-assisted and manual TKA procedures, necessitating adjustments by surgeons based on their experience. Consequently, there is an urgent need to develop a mathematical formula that quantifies these differences to guide intraoperative alignment. Additionally, the Mako-assisted TKA femoral prosthesis exhibits a head-lowering issue, and differences exist in the posterior slope angle of the tibial plateau compared to manual TKA, necessitating further comparative analysis to draw definitive conclusions. This study will be carried out at the People's Liberation Army General Hospital, with an anticipated enrollment of approximately 100 participants.