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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Post-traumatic Arthritis

Status

Terminated

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Hip, Cemented

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

North Bristol NHS Trust

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

C-Stem™ AMT Femoral Component

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ML/AP translation and all rotations out to 5 years

Harris Hip score

Oxford Hip score

Radiological analysis

Full Information

NCT ID

NCT00872573

First Posted

March 30, 2009

Last Updated

June 23, 2017

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00872573

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Technical issues with RSA at main site and departure of Principal Investigator

Study Start Date

July 1, 2006 (Actual)

Primary Completion Date

October 1, 2007 (Actual)

Study Completion Date

October 1, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Hip, Cemented

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C-Stem™ AMT Femoral Component

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

ML/AP translation and all rotations out to 5 years

Time Frame

pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery

Title

Harris Hip score

Time Frame

3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

Title

Oxford Hip score

Time Frame

3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

Title

Radiological analysis

Time Frame

3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

North Bristol NHS Trust

City

Bristol

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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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