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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00872573
• Other study ID #: CT03/14
• Status: Terminated
• Phase: Phase 4
• First received: March 30, 2009
• Last updated: June 23, 2017
• Start date: July 1, 2006
• Est. completion date: October 1, 2007

Study information

• Verified date: June 2017
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 1, 2007
• Est. primary completion date: October 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Collagen Diseases
• Collagen Disorders
• Congenital Hip Dysplasia
• Femoral Fractures
• Fractures, Bone
• Hip Dislocation
• Hip Dislocation, Congenital
• Necrosis
• Nonunion of Femoral Fractures
• Osteoarthritis
• Post-traumatic Arthritis
• Rheumatic Diseases
• Rheumatoid Arthritis
• Slipped Capital Femoral Epiphyses
• Slipped Capital Femoral Epiphysis
• Traumatic Femoral Fractures

Intervention

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

Locations

Country	Name	City	State
United Kingdom	North Bristol NHS Trust	Bristol

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal migration of the femoral stem at the 5-year time point		5 years
Secondary	ML/AP translation and all rotations out to 5 years		pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery
Secondary	Harris Hip score		3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Secondary	Oxford Hip score		3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery
Secondary	Radiological analysis		3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery