Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

This study has been terminated.
(Technical issues with RSA at main site and departure of Principal Investigator)
Information provided by (Responsible Party):
DePuy International Identifier:
First received: March 30, 2009
Last updated: July 1, 2016
Last verified: June 2016
The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used 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, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.

Condition Intervention Phase
Rheumatoid Arthritis
Post-traumatic Arthritis
Collagen Disorders
Avascular Necrosis
Traumatic Femoral Fractures
Nonunion of Femoral Fractures
Congenital Hip Dysplasia
Slipped Capital Femoral Epiphysis.
Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.

Resource links provided by NLM:

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Distal migration of the femoral stem at the 5-year time point [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • ML/AP translation and all rotations out to 5 years [ Time Frame: pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery ]
  • Harris Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]
  • Oxford Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]
  • Radiological analysis [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ]

Enrollment: 5
Study Start Date: July 2006
Estimated Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)
    A polished triple tapered cemented femoral component for use in total hip replacement

Ages Eligible for Study:   60 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

i) Male or female subjects, aged between 60 and 80 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 undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.

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 undergoing revision hip replacement

iii) Subjects undergoing simultaneous bilateral hip replacements.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00872573

United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Sponsors and Collaborators
DePuy International
  More Information

Responsible Party: DePuy International Identifier: NCT00872573     History of Changes
Other Study ID Numbers: CT03/14
Study First Received: March 30, 2009
Last Updated: July 1, 2016

Keywords provided by DePuy International:

Additional relevant MeSH terms:
Fractures, Bone
Arthritis, Rheumatoid
Hip Dislocation
Hip Dislocation, Congenital
Femoral Fractures
Slipped Capital Femoral Epiphyses
Collagen Diseases
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Leg Injuries
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped processed this record on April 25, 2017