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 (Responsible Party):

DePuy International

ClinicalTrials.gov Identifier:

NCT00872573

First received: March 30, 2009

Last updated: July 1, 2016

Last verified: June 2016

History of Changes

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:

Genetics Home Reference related topics: geleophysic dysplasia mucopolysaccharidosis type IV rheumatoid arthritis

MedlinePlus related topics: Hip Replacement Leg Injuries and Disorders

Genetic and Rare Diseases Information Center resources: Mucopolysaccharidosis Type IV

U.S. FDA Resources

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 ]


Enrollment:	5
Study Start Date:	July 2006
Estimated Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Intervention Details:

A polished triple tapered cemented femoral component for use in total hip replacement

Eligibility


Ages Eligible for Study:	60 Years to 80 Years (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	DePuy International
ClinicalTrials.gov Identifier:	NCT00872573 History of Changes
Other Study ID Numbers:	CT03/14
Study First Received:	March 30, 2009
Last Updated:	July 1, 2016
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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 Dislocations Hip Injuries Musculoskeletal Abnormalities Congenital Abnormalities Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases Epiphyses, Slipped

ClinicalTrials.gov processed this record on September 30, 2016

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