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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208390
• Other study ID #: CT01/25
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: August 3, 2016
• Start date: February 2003
• Est. completion date: May 2012

Study information

• Verified date: July 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Medicines and Medical Devices Safety Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 275
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Femoral Fractures
• Fractures, Bone
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis
• Traumatic Femoral Fractures

Intervention

Device:
• Summit Tapered Hip System
A cementless, tapered femoral component for use in total hip replacement

Locations

Country	Name	City	State
China	2. Ruijin Hospital	Shanghai
Hong Kong	3. The University of Hong Kong at Queen Mary Hospital	Pokfulam
Italy	1. Ospedale Riuniti Di Bergamo	Bergamo
Korea, Republic of	4. Yonsei University College of Medicine	Seoul
New Zealand	5. Middlemore Hospital	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

China,  Hong Kong,  Italy,  Korea, Republic of,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kaplan-Meier survivorship calculated at the five-year time point		5yrs post-surgery	Yes
Secondary	Kaplan-Meier survivorship calculations		Annually	Yes
Secondary	Harris Hip score		6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery	No
Secondary	Oxford score		6mths and Annually post-surgery	No
Secondary	UCLA activity rating		6mths and Annually post-surgery	No
Secondary	Thigh pain analysis		6mths and Annually post-surgery	No
Secondary	Radiological analysis		pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery	No