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

Primary Purpose

Primary Arthritis, Secondary Arthritis

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Silent™ Hip
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Arthritis focused on measuring Hip Replacement, Femoral Component

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sygehus Sønderjyllands
  • Orthopädie Kupfalz
  • Orthopaedic Clinic University La Sapienza
  • Hospital Nisa Sevilla-Aljarafe
  • Hospital San Juan de Dios del Aljarafe
  • Hospital Santa Ángela De La Cruz
  • Princess Alexandra Hospital
  • The Rivers Hospital
  • Wrightington Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Silent™ Hip

Arm Description

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

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship

Secondary Outcome Measures

Oxford Hip Score
University of California Los Angeles (UCLA) Activity Score
EuroQol EQ-5D
Harris Hip Score
Radiographic analysis
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
Oxford Hip Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
University of California Los Angeles (UCLA) Activity Score
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
EuroQol EQ-5D
Harris Hip Score
Harris Hip Score
Harris Hip Score
Harris Hip Score
Radiographic analysis
Radiographic analysis
Radiographic analysis
Radiographic analysis
Radiographic analysis
Radiographic analysis

Full Information

First Posted
June 27, 2011
Last Updated
May 25, 2016
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT01383824
Brief Title
A Multi-centre Study to Assess the Long-term Performance of the Silent Hip™ in Primary Total Hip Replacement Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Rationalization of the Silent Hip Prosthesis for business reasons only
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy International

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Arthritis, Secondary Arthritis
Keywords
Hip Replacement, Femoral Component

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silent™ Hip
Arm Type
Other
Arm Description
A short cementless, femoral component for use in total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
Silent™ Hip
Intervention Description
A short cementless, femoral component for use in total hip arthroplasty
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship
Time Frame
5 years post-surgery
Secondary Outcome Measure Information:
Title
Oxford Hip Score
Time Frame
6 weeks-6 mths
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
6 weeks-6 mths
Title
EuroQol EQ-5D
Time Frame
6 weeks-6 mths
Title
Harris Hip Score
Time Frame
6 weeks-6 mths
Title
Radiographic analysis
Time Frame
pre-discharge
Title
Oxford Hip Score
Time Frame
2 years
Title
Oxford Hip Score
Time Frame
3 years
Title
Oxford Hip Score
Time Frame
4 Years
Title
Oxford Hip Score
Time Frame
5 years
Title
Oxford Hip Score
Time Frame
6 Years
Title
Oxford Hip Score
Time Frame
7 Years
Title
Oxford Hip Score
Time Frame
8 Years
Title
Oxford Hip Score
Time Frame
9 years
Title
Oxford Hip Score
Time Frame
10 Years
Title
Oxford Hip Score
Time Frame
11 Years
Title
Oxford Hip Score
Time Frame
12 Years
Title
Oxford Hip Score
Time Frame
13 Years
Title
Oxford Hip Score
Time Frame
14 Years
Title
Oxford Hip Score
Time Frame
15 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
2 years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
3 years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
4 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
5 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
6 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
7 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
8 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
9 years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
10 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
11 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
12 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
13 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
14 Years
Title
University of California Los Angeles (UCLA) Activity Score
Time Frame
15 years
Title
EuroQol EQ-5D
Time Frame
2 Years
Title
EuroQol EQ-5D
Time Frame
3 Years
Title
EuroQol EQ-5D
Time Frame
4 Years
Title
EuroQol EQ-5D
Time Frame
5 Years
Title
EuroQol EQ-5D
Time Frame
6 years
Title
EuroQol EQ-5D
Time Frame
7 years
Title
EuroQol EQ-5D
Time Frame
8 Years
Title
EuroQol EQ-5D
Time Frame
9 Years
Title
EuroQol EQ-5D
Time Frame
10 Years
Title
EuroQol EQ-5D
Time Frame
11 Years
Title
EuroQol EQ-5D
Time Frame
12 Years
Title
EuroQol EQ-5D
Time Frame
13 Years
Title
EuroQol EQ-5D
Time Frame
14 Years
Title
EuroQol EQ-5D
Time Frame
15 Years
Title
Harris Hip Score
Time Frame
2 Years
Title
Harris Hip Score
Time Frame
5 Years
Title
Harris Hip Score
Time Frame
10 Years
Title
Harris Hip Score
Time Frame
15 Years
Title
Radiographic analysis
Time Frame
6 weeks - 6 mths
Title
Radiographic analysis
Time Frame
1 year
Title
Radiographic analysis
Time Frame
2 Years
Title
Radiographic analysis
Time Frame
5 Years
Title
Radiographic analysis
Time Frame
10 years
Title
Radiographic analysis
Time Frame
15 Years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Sygehus Sønderjyllands
City
Sønderborg
Country
Denmark
Facility Name
Orthopädie Kupfalz
City
Speyer
Country
Germany
Facility Name
Orthopaedic Clinic University La Sapienza
City
Rome
Country
Italy
Facility Name
Hospital Nisa Sevilla-Aljarafe
City
Sevilla
Country
Spain
Facility Name
Hospital San Juan de Dios del Aljarafe
City
Sevilla
Country
Spain
Facility Name
Hospital Santa Ángela De La Cruz
City
Sevilla
Country
Spain
Facility Name
Princess Alexandra Hospital
City
Harlow
State/Province
Essex
Country
United Kingdom
Facility Name
The Rivers Hospital
City
Sawbridgeworth
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
Wrightington Hospital
City
Wrightington
State/Province
Lancashire
ZIP/Postal Code
WN6 9EP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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