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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Summit Tapered Hip System
Sponsored by
DePuy International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Cementless

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: i) Male or female subjects, aged between 18 and 70 years (inclusive). ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims.

Sites / Locations

  • 2. Ruijin Hospital
  • 3. The University of Hong Kong at Queen Mary Hospital
  • 1. Ospedale Riuniti Di Bergamo
  • 4. Yonsei University College of Medicine
  • 5. Middlemore Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Summit Tapered Hip System

Arm Description

A cementless, tapered femoral component for use in total hip replacement

Outcomes

Primary Outcome Measures

Kaplan-Meier survivorship calculated at the five-year time point

Secondary Outcome Measures

Kaplan-Meier survivorship calculations
Harris Hip score
Oxford score
UCLA activity rating
Thigh pain analysis
Radiological analysis

Full Information

First Posted
September 13, 2005
Last Updated
August 3, 2016
Sponsor
DePuy International
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1. Study Identification

Unique Protocol Identification Number
NCT00208390
Brief Title
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Official Title
Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Study closed after the 5 year end-point was reached after a review of the status further to a request from the investigators to discontinue participation.
Study Start Date
February 2003 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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 of the Summit™ 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
Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis, Collagen Disorders, Avascular Necrosis, Traumatic Femoral Fractures, Nonunion of Femoral Fractures, Congenital Hip Dysplasia, Slipped Capital Femoral Epiphysis
Keywords
Hip, Cementless

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
275 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Summit Tapered Hip System
Arm Type
Other
Arm Description
A cementless, tapered femoral component for use in total hip replacement
Intervention Type
Device
Intervention Name(s)
Summit Tapered Hip System
Intervention Description
A cementless, tapered femoral component for use in total hip replacement
Primary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculated at the five-year time point
Time Frame
5yrs post-surgery
Secondary Outcome Measure Information:
Title
Kaplan-Meier survivorship calculations
Time Frame
Annually
Title
Harris Hip score
Time Frame
6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Title
Oxford score
Time Frame
6mths and Annually post-surgery
Title
UCLA activity rating
Time Frame
6mths and Annually post-surgery
Title
Thigh pain analysis
Time Frame
6mths and Annually post-surgery
Title
Radiological analysis
Time Frame
pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: i) Male or female subjects, aged between 18 and 70 years (inclusive). ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem. Exclusion Criteria: i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study. ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty. iii) Women who are pregnant. iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. v) Subjects who have participated in a clinical study with an investigational product in the last 12 months. vi) Subjects who are currently involved in any injury litigation claims.
Facility Information:
Facility Name
2. Ruijin Hospital
City
Shanghai
Country
China
Facility Name
3. The University of Hong Kong at Queen Mary Hospital
City
Pokfulam
Country
Hong Kong
Facility Name
1. Ospedale Riuniti Di Bergamo
City
Bergamo
Country
Italy
Facility Name
4. Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
5. Middlemore Hospital
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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