Depuy INHANCE Stemless IDE - Clinical Trial

¿Cuál es el Propósito de este estudio?

This study does not require much extra time from patients, but doctors will check on them closely for two years. People in the study are placed into groups by chance. Two out of every three people will get the new shoulder device, and one out of three will get the regular device that uses a stem.

¿Cuál es la Condición que se está estudiando?

This study is looking at a new shoulder replacement device that does not use a long metal rod inside the arm bone. These devices are called stemless prostheses. They are made for people who have very bad shoulder arthritis and sometimes tears in the rotator cuff.

¿Quién puede participar en el Estudio?

People can join this study if they are older than 55 years. They must have shoulder arthritis or a rotator cuff tear that cannot be treated in other ways. They cannot join if they have cancer, serious mental health problems, or a chronic pain condition.

Grupo etario
Adultos

¿Qué Implica?

This study is being done to see if a new stemless reverse shoulder device works as well as or better than the shoulder replacements that are used now. Researchers hope the new device may lead to shorter surgeries, fewer problems, and better results for patients.

Detalles del Estudio

Título Completo
Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Investigador Principal
Tally E. Lassiter Jr., MD, MHA
Especialista en cirugía ortopédica en medicina deportiva
Número de Protocolo
IRB: PRO00117873
NCT: NCT06323980
Fase
Fase N/A
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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Contribuya a Duke Health