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

This study has been terminated.
(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.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208390
First received: September 13, 2005
Last updated: September 8, 2014
Last verified: July 2014

September 13, 2005
September 8, 2014
March 2003
November 2011   (final data collection date for primary outcome measure)
Kaplan-Meier survivorship calculated at the five-year time point [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00208390 on ClinicalTrials.gov Archive Site
  • Kaplan-Meier survivorship calculations [ Time Frame: Annually ] [ Designated as safety issue: Yes ]
  • Harris Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • UCLA activity rating [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Thigh pain analysis [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiological analysis [ Time Frame: pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
A Multi-centre Study to Assess the Long-term Performance of the Summit™ Hip in Primary Total Hip Replacement
Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Post-traumatic Arthritis
  • Collagen Disorders
  • Avascular Necrosis
  • Traumatic Femoral Fractures
  • Nonunion of Femoral Fractures
  • Congenital Hip Dysplasia
  • Slipped Capital Femoral Epiphysis
Device: Summit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement
Summit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement
Intervention: Device: Summit Tapered Hip System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
293
November 2011
November 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong,   Italy,   Korea, Republic of,   New Zealand
 
NCT00208390
CT01/25
No
DePuy International
DePuy International
Not Provided
Not Provided
DePuy International
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP