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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
North Bristol NHS Trust
Bristol, United Kingdom

Sponsors and Collaborators

DePuy International

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	DePuy International
ClinicalTrials.gov Identifier:	NCT00872573 History of Changes
Other Study ID Numbers:	CT03/14
First Posted:	March 31, 2009
Last Update Posted:	June 26, 2017
Last Verified:	June 2017

Keywords provided by DePuy International:

Hip; Cemented

Additional relevant MeSH terms:

Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Fractures, Bone; Necrosis; Femoral Fractures; Hip Dislocation; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses; Collagen Diseases; Rheumatic Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases	Autoimmune Diseases; Immune System Diseases; Wounds and Injuries; Pathologic Processes; Leg Injuries; Joint Dislocations; Bone Diseases; Hip Injuries; Musculoskeletal Abnormalities; Congenital Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped