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

A Multi-centre, Prospective, Uncontrolled Post Market Clinical Follow-up Study (PMCFS) to Monitor the Survival and Performance of the Silent™ Hip in Subjects Requiring a Total Hip Replacement

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 Overview

• Status: Terminated
• Conditions: Secondary Arthritis; Primary Arthritis
• Intervention / Treatment: Device: Silent™ Hip

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Sønderborg, Denmark
    • Sygehus Sønderjyllands
• Germany
  • Speyer, Germany
    • Orthopädie Kupfalz
• Italy
  • Rome, Italy
    • Orthopaedic Clinic University La Sapienza
• Spain
  • Sevilla, Spain
    • Hospital Nisa Sevilla-Aljarafe
  • Sevilla, Spain
    • Hospital San Juan de Dios del Aljarafe
  • Sevilla, Spain
    • Hospital Santa Ángela De La Cruz
• United Kingdom
  • Essex
    • Harlow, Essex, United Kingdom
      • Princess Alexandra Hospital
  • Hertfordshire
    • Sawbridgeworth, Hertfordshire, United Kingdom
      • The Rivers Hospital
  • Lancashire
    • Wrightington, Lancashire, United Kingdom, WN6 9EP
      • Wrightington Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Silent™ Hip; A short cementless, femoral component for use in total hip arthroplasty	Device: Silent™ Hip; A short cementless, femoral component for use in total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship	5 years post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Oxford Hip Score	6 weeks-6 mths
University of California Los Angeles (UCLA) Activity Score	6 weeks-6 mths
EuroQol EQ-5D	6 weeks-6 mths
Harris Hip Score	6 weeks-6 mths
Radiographic analysis	pre-discharge
Oxford Hip Score	2 years
Oxford Hip Score	3 years
Oxford Hip Score	4 Years
Oxford Hip Score	5 years
Oxford Hip Score	6 Years
Oxford Hip Score	7 Years
Oxford Hip Score	8 Years
Oxford Hip Score	9 years
Oxford Hip Score	10 Years
Oxford Hip Score	11 Years
Oxford Hip Score	12 Years
Oxford Hip Score	13 Years
Oxford Hip Score	14 Years
Oxford Hip Score	15 Years
University of California Los Angeles (UCLA) Activity Score	2 years
University of California Los Angeles (UCLA) Activity Score	3 years
University of California Los Angeles (UCLA) Activity Score	4 Years
University of California Los Angeles (UCLA) Activity Score	5 Years
University of California Los Angeles (UCLA) Activity Score	6 Years
University of California Los Angeles (UCLA) Activity Score	7 Years
University of California Los Angeles (UCLA) Activity Score	8 Years
University of California Los Angeles (UCLA) Activity Score	9 years
University of California Los Angeles (UCLA) Activity Score	10 Years
University of California Los Angeles (UCLA) Activity Score	11 Years
University of California Los Angeles (UCLA) Activity Score	12 Years
University of California Los Angeles (UCLA) Activity Score	13 Years
University of California Los Angeles (UCLA) Activity Score	14 Years
University of California Los Angeles (UCLA) Activity Score	15 years
EuroQol EQ-5D	2 Years
EuroQol EQ-5D	3 Years
EuroQol EQ-5D	4 Years
EuroQol EQ-5D	5 Years
EuroQol EQ-5D	6 years
EuroQol EQ-5D	7 years
EuroQol EQ-5D	8 Years
EuroQol EQ-5D	9 Years
EuroQol EQ-5D	10 Years
EuroQol EQ-5D	11 Years
EuroQol EQ-5D	12 Years
EuroQol EQ-5D	13 Years
EuroQol EQ-5D	14 Years
EuroQol EQ-5D	15 Years
Harris Hip Score	2 Years
Harris Hip Score	5 Years
Harris Hip Score	10 Years
Harris Hip Score	15 Years
Radiographic analysis	6 weeks - 6 mths
Radiographic analysis	1 year
Radiographic analysis	2 Years
Radiographic analysis	5 Years
Radiographic analysis	10 years
Radiographic analysis	15 Years

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Hip Replacement; Femoral Component
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CT09/02