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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DePuy Synthes

Status and phase

Terminated
Phase 4

Conditions

Osteoarthritis
Slipped Capital Femoral Epiphysis
Congenital Hip Dysplasia
Collagen Disorders
Avascular Necrosis
Nonunion of Femoral Fractures
Post-traumatic Arthritis
Traumatic Femoral Fractures
Rheumatoid Arthritis

Treatments

Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00872573
CT03/14

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

C-Stem™ AMT Femoral Component
Other group
Treatment:
Device: C-Stem™ AMT Femoral Component (standard and high off-set variants)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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