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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00208390
First received: September 13, 2005
Last updated: September 1, 2011
Last verified: September 2011
History of Changes
  Purpose

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 Intervention 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
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Kaplan-Meier survivorship calculated at the five-year time point [ Time Frame: 5yrs post-surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 293
Study Start Date: March 2003
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Summit Tapered Hip System
    A cementless, tapered femoral component for use in total hip replacement
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208390

Locations
China
2. Ruijin Hospital
Shanghai, China
Hong Kong
3. The University of Hong Kong at Queen Mary Hospital
Pokfulam, Hong Kong
Italy
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
  More Information

No publications provided

Responsible Party: Roy Harvey, Clinical Research Manager, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00208390     History of Changes
Other Study ID Numbers: CT01/25
Study First Received: September 13, 2005
Last Updated: September 1, 2011
Health Authority: New Zealand: Medicines and Medical Devices Safety Authority

Keywords provided by DePuy International:
Hip
Cementless

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Wounds and Injuries
Leg Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 23, 2013