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

Phase 4

Terminated

• Conditions: Rheumatoid Arthritis; Post-traumatic Arthritis; Osteoarthritis; Collagen Disorders; Avascular Necrosis; Traumatic Femoral Fractures; Nonunion of Femoral Fractures; Congenital Hip Dysplasia; Slipped Capital Femoral Epiphysis
• Interventions: Device: Summit Tapered Hip System

• Registration Number: NCT00208390
• Lead Sponsor: DePuy International

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 275

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Summit Tapered Hip System	Summit Tapered Hip System	A cementless, tapered femoral component for use in total hip replacement

Primary Outcome Measures

Name	Time	Method
Kaplan-Meier survivorship calculated at the five-year time point	5yrs post-surgery

Secondary Outcome Measures

Name	Time	Method
Harris Hip score	6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
UCLA activity rating	6mths and Annually post-surgery
Kaplan-Meier survivorship calculations	Annually
Oxford score	6mths and Annually post-surgery
Thigh pain analysis	6mths and Annually post-surgery
Radiological analysis	pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery

Trial Locations

Locations (5)

2. Ruijin Hospital; 🇨🇳 Shanghai, China

1. Ospedale Riuniti Di Bergamo; 🇮🇹 Bergamo, Italy

4. Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of

5. Middlemore Hospital; 🇳🇿 Auckland, New Zealand

3. The University of Hong Kong at Queen Mary Hospital; 🇭🇰 Pokfulam, Hong Kong