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

NCT00872573 | Terminated Phase 4

• 1 other identifier: CT03/14
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (4)

• ML/AP translation and all rotations out to 5 years

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

• Harris Hip score

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

• Oxford Hip score

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

• Radiological analysis

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

Study Arms (1)

C-Stem™ AMT Femoral Component

OTHER

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

Interventions

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

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

C-Stem™ AMT Femoral Component

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• DePuy International: lead

Study Sites (1)

North Bristol NHS Trust

Bristol, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Collagen Diseases; Osteonecrosis; Hip Dislocation, Congenital; Slipped Capital Femoral Epiphyses

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Osteochondrodysplasias; Bone Diseases, Developmental; Epiphyses, Slipped

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: July 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 26, 2017

Record last verified: 2017-06

Locations

GB (1)