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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 275
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Summit Tapered Hip System; A cementless, tapered femoral component for use in total hip replacement	Device: Summit Tapered Hip System; A cementless, tapered femoral component for use in total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship calculated at the five-year time point	5yrs post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier survivorship calculations	Annually
Harris Hip score	6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery
Oxford score	6mths and Annually post-surgery
UCLA activity rating	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

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): August 4, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hip; Cementless
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Joint Dislocations; Bone Diseases, Developmental; Osteochondrodysplasias; Epiphyses, Slipped; Femoral Fractures; Arthritis; Necrosis; Fractures, Bone; Rheumatic Diseases; Collagen Diseases; Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses
• Other Study ID Numbers: CT01/25