Clinical Research Directory

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay

This is a post-marketing surveillance on MiniMAX Stem

Hydrogel Coating to Reduce Post-surgical Infection After Joint Arthroplasty

The goal of this randomized, controlled, monocentric, single-blind, 2-arm, feasibility clinical investigation is to evaluate the safety of MectaShield hydrogel coating and to capture its preliminary clinical performance in the prevention of early peri-prosthetic joint infection (PJI) in patients undergoing cementless revision hip arthroplasty. The main questions it aims to answer are: * demonstrate that the hydrogel coating MectaShield does not interfere with primary stability; * evaluate clinical and functional outcomes, the rate of PJI and possible adverse events. Participants will undergo cementless revision hip arthroplasty; during surgery MectaShield hydrogel coating is applied on orthopaedic implants' surfaces (femoral stem and, if revised, acetabular cup) as a protective barrier for the prevention of bacterial adhesion. Surgery and follow-up are completed as per local standard practice. Stability will be assessed radiologically, while functional outcomes and PJI will be monitored by HOOS-PS, ASESPIS scores and according to the consensus document presented by European Society of Radiology (ESRa), the European Association of Nuclear Medicine (EANM), the European Bone and Joint Infection Society (EBJIS), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID). Researchers will compare the results of the treatment group with those from a control group receiving cementless revision hip arthroplasty without the application of MectaShiled hydrogel coating.

PMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty

This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.

Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.

Sickle Cell Disease (SCD) Bone Pain Study

A prospective study to determine how low bone mineral density and/or vertebral compression fractures associate with pain in adults with sickle cell disease

Persona Ti-Nidium Post-Market Clinical Follow-up

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Perform Humeral System Study

This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study, which is designed to collect safety and performance data at baseline, surgery, immediate post-op and annually through 10 years post-operation. Data collected from this study will be used for purposes, including but not limited to, Post-Market Surveillance, peer-reviewed publications, education materials, regulatory submissions, and/or product development.

Pyrocarbon Clinical Follow-up Study

The objective of this multi-center study is to collect medium and long-term data on the related clinical complications and functional outcomes of the Pyrocarbon Humeral Head to demonstrate safety and performance, in subjects from the Pyrocarbon IDE Study cohort. Data collected from this study will support post-market surveillance and MDR requirements as well provide the basis for peer-reviewed publications on mid- and long-term product performance and safety (five to ten years post-op).

Anatomical Shoulder Domelock System Study

The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event records.

Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis

Database Retrieval for the Comprehensive Shoulder

This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products. The primary objective of the retrieval is to collect data that will contribute to the post market surveillance requirements for this product and will provide feedback to design engineers, support marketing efforts and publications, and answer potential questions form reimbursement agencies.

Effect of HBOT on Femoral Head Avascular Necrosis (AVN)

The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.

Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System

This study is designed as a prospective, multicenter, observational post-market clinical follow-up (PMCF) study to evaluate the safety and effectiveness of the Tipmed™ Shoulder Prosthesis System at 12 months postoperatively. The study population includes adult patients who undergo reverse shoulder arthroplasty (RSA) or shoulder hemiarthroplasty (HA) using the Tipmed™ implant systems due to various clinical indications such as osteoarthritis, rotator cuff arthropathy, or proximal humerus fractures. The main objective is to gather real-world clinical evidence on the 12-month post-operative safety profile, potential complications, and functional outcomes of the device during routine clinical practice.

TESS V3 Modular Total Shoulder System PMCF

This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.

Sidus(TM) Post Market Clinical Follow-up (PMCF) Study

This post market clinical follow-up study is designed to confirm safety and performance of the Sidus Stem-Free Shoulder when used in hemi or total shoulder arthroplasty. The safety of the implant will be evaluated by monitoring the frequency and incidence of all kinds of adverse events. The performance will be determined by analyzing the implant survival, overall pain and functional performances (based on Constant \& Murley score and ASES score), subject quality of life (EuroQol EQ5D) and radiographic parameters (e.g. radiolucencies, osteolysis, component migration) of study subjects who received the Sidus Stem-Free Shoulder. The Sidus Stem-Free Shoulder is not approved for use in the US.

Insignia™ Hip Stem Outcomes Study

The objective of this study is to evaluate the safety and effectiveness of the Insignia™ Hip Stem for global market access and post-market clinical follow-up up to 10 years postoperative.

Pentoxifylline and Tocopherol (PENTO) in the Treatment of Medication-related Osteonecrosis of the Jaw (MRONJ)

The overall purpose of this project is to answer the following clinical question: Among Medication-Related Osteonecrosis of the Jaw (MRONJ) patients, do those who are treated with the Pentoxifylline and Tocopherol (PENTO) regimen and standard of care, when compared to those treated with standard of care alone, have decreased areas of exposed bone after one year of treatment?

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.

Cemented vs Cementless Persona Keel RCT

The main objective of this study is to evaluate the safety, performance, and clinical benefits of the Persona Keel cementless and cemented knee.

Persona Partial Knee Clinical Outcomes Study

The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available Persona Partial Knee System.

Comprehensive Nano - Post Market Clinical Follow-Up Study

This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

The Use of Genex in the Management of Early-Stage Osteonecrosis of the Femoral Head

The purpose of this study is to assess the clinical and x-ray results of patients who are treated with core decompression of the hip and the injection of a bone marrow concentrate and the use of the Bone Graft Substitute Genex®.

Tornier HRS (Humeral Reconstruction System) Study (REVIVE)

This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system in both the anatomic and reversed configurations. Retrospective inclusions are allowed: study patients may be enrolled up to 3 months after date of surgery provided that the necessary pre-operative (baseline) and surgery data are accessible. Follow-up visits conducted from 3-month post-surgery onward must be prospective. The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.