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

Sponsor

DePuy International (Industry)

Overall Status

Terminated

CT.gov ID

NCT00872573

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

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 :

Jul 1, 2006

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Primary Outcome Measures

Distal migration of the femoral stem at the 5-year time point [5 years]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subjects, aged between 60 and 80 years inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
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.
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:

Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
Subjects undergoing revision hip replacement
Subjects undergoing simultaneous bilateral hip replacements.
Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
Women who are pregnant.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical study with an investigational product in the last 12 months.
Subjects who are currently involved in any injury litigation claims.