A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery

DePuy International89 enrolled

Overview

The purpose of this study is to monitor the performance and of the Silent Hip™ in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Arthritis Secondary Arthritis

Interventions

Silent™ HipDEVICE

A short cementless, femoral component for use in total hip arthroplasty

Eligibility

Sex: ALLMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any subject deemed suitable to receive the Silent™ Hip in combination with the Pinnacle™ acetabular cup system, in accordance with all applicable Instructions For Use, should be considered for entry into this study. Exclusion Criteria: * Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.

Locations (9)

Sygehus Sønderjyllands

Sønderborg, Denmark

Orthopädie Kupfalz

Speyer, Germany

Orthopaedic Clinic University La Sapienza

Rome, Italy

Hospital Nisa Sevilla-Aljarafe

Seville, Spain

Outcomes

Primary Outcomes

Kaplan-Meier survivorship

Time frame: 5 years post-surgery

Secondary Outcomes

Oxford Hip Score

Time frame: 6 weeks-6 mths

University of California Los Angeles (UCLA) Activity Score

Time frame: 6 weeks-6 mths

EuroQol EQ-5D

Time frame: 6 weeks-6 mths

Harris Hip Score

Time frame: 6 weeks-6 mths

Radiographic analysis

Time frame: pre-discharge

Oxford Hip Score

Time frame: 2 years

Oxford Hip Score

Time frame: 3 years

Oxford Hip Score

Time frame: 4 Years

Oxford Hip Score

Time frame: 5 years

Oxford Hip Score

Time frame: 6 Years

Oxford Hip Score

Time frame: 7 Years

Oxford Hip Score

Time frame: 8 Years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Hospital San Juan de Dios del Aljarafe

Seville, Spain

Hospital Santa Ángela De La Cruz

Seville, Spain

Princess Alexandra Hospital

Harlow, Essex, United Kingdom

The Rivers Hospital

Sawbridgeworth, Hertfordshire, United Kingdom

Wrightington Hospital

Wrightington, Lancashire, United Kingdom

Oxford Hip Score

Time frame: 10 Years

Oxford Hip Score

Time frame: 11 Years

Oxford Hip Score

Time frame: 12 Years

Oxford Hip Score

Time frame: 13 Years

Oxford Hip Score

Time frame: 14 Years

Oxford Hip Score

Time frame: 15 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 2 years

University of California Los Angeles (UCLA) Activity Score

Time frame: 3 years

University of California Los Angeles (UCLA) Activity Score

Time frame: 4 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 5 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 6 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 7 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 8 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 9 years

University of California Los Angeles (UCLA) Activity Score

Time frame: 10 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 11 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 12 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 13 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 14 Years

University of California Los Angeles (UCLA) Activity Score

Time frame: 15 years

EuroQol EQ-5D

Time frame: 2 Years

EuroQol EQ-5D

Time frame: 3 Years

EuroQol EQ-5D

Time frame: 4 Years

EuroQol EQ-5D

Time frame: 5 Years

EuroQol EQ-5D

Time frame: 6 years

EuroQol EQ-5D

Time frame: 7 years

EuroQol EQ-5D

Time frame: 8 Years

EuroQol EQ-5D

Time frame: 9 Years

EuroQol EQ-5D

Time frame: 10 Years

EuroQol EQ-5D

Time frame: 11 Years

EuroQol EQ-5D

Time frame: 12 Years

EuroQol EQ-5D

Time frame: 13 Years

EuroQol EQ-5D

Time frame: 14 Years

EuroQol EQ-5D

Time frame: 15 Years

Harris Hip Score

Time frame: 2 Years

Harris Hip Score

Time frame: 5 Years

Harris Hip Score

Time frame: 10 Years

Harris Hip Score

Time frame: 15 Years

Radiographic analysis

Time frame: 6 weeks - 6 mths

Radiographic analysis

Time frame: 1 year

Radiographic analysis

Time frame: 2 Years

Radiographic analysis

Time frame: 5 Years

Radiographic analysis

Time frame: 10 years

Radiographic analysis

Time frame: 15 Years