Trial record 20 of 34 for:    "Developmental dysplasia of hip"

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)
Sponsor:
Information provided by:
DePuy International
ClinicalTrials.gov Identifier:
NCT00872573
First received: March 30, 2009
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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
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 Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Harris Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Oxford Hip score [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]
  • Radiological analysis [ Time Frame: 3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2006
Estimated Primary Completion Date: December 2014 (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
  Eligibility

Ages Eligible for Study:   60 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872573

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

No publications provided

Responsible Party: Roy Harvey, Clinical Research Manager, DePuy International Ltd
ClinicalTrials.gov Identifier: NCT00872573     History of Changes
Other Study ID Numbers: CT03/14
Study First Received: March 30, 2009
Last Updated: September 1, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by DePuy International:
Hip
Cemented

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Collagen Diseases
Femoral Fractures
Fractures, Bone
Hip Dislocation, Congenital
Necrosis
Osteonecrosis
Osteoarthritis
Hip Dislocation
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
Dislocations
Hip Injuries

ClinicalTrials.gov processed this record on April 17, 2014