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

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ClinicalTrials.gov Identifier: NCT00208390
Recruitment Status : 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.)
First Posted : September 21, 2005
Last Update Posted : August 4, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 275 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Kaplan-Meier survivorship calculated at the five-year time point [ Time Frame: 5yrs post-surgery ]

Secondary Outcome Measures :
  1. Kaplan-Meier survivorship calculations [ Time Frame: Annually ]
  2. Harris Hip score [ Time Frame: 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ]
  3. Oxford score [ Time Frame: 6mths and Annually post-surgery ]
  4. UCLA activity rating [ Time Frame: 6mths and Annually post-surgery ]
  5. Thigh pain analysis [ Time Frame: 6mths and Annually post-surgery ]
  6. Radiological analysis [ Time Frame: pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208390

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

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208390     History of Changes
Other Study ID Numbers: CT01/25
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: July 2016

Keywords provided by DePuy International:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Fractures, Bone
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Pathologic Processes
Leg Injuries
Joint Dislocations
Bone Diseases
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Bone Diseases, Developmental
Epiphyses, Slipped