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

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ClinicalTrials.gov Identifier: NCT00872573
Recruitment Status : Terminated (Technical issues with RSA at main site and departure of Principal Investigator)
First Posted : March 31, 2009
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
DePuy International

Study Description
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Brief Summary:
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 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: C-Stem™ AMT Femoral Component (standard and high off-set variants) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Actual Study Start Date : July 1, 2006
Actual Primary Completion Date : October 1, 2007
Actual Study Completion Date : October 1, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arms and Interventions
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Arm Intervention/treatment
C-Stem™ AMT Femoral Component 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


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

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

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

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
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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): NCT00872573


Locations
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United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom
Sponsors and Collaborators
DePuy International
More Information
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Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00872573     History of Changes
Other Study ID Numbers: CT03/14
First Posted: March 31, 2009    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

Keywords provided by DePuy International:
Hip
Cemented

Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Fractures, Bone
Arthritis, Rheumatoid
Necrosis
Femoral Fractures
Hip Dislocation
Hip Dislocation, Congenital
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
Leg Injuries
Joint Dislocations
Hip Injuries
Musculoskeletal Abnormalities
Congenital Abnormalities
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Epiphyses, Slipped