A Randomised Single Centre Study to Compare the Long-term Performance of Acryloc™ and Palacos® R Bone Cements in Primary Total Hip Replacement

Phase 4

Terminated

• Conditions: Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis
• Interventions: Device: Palacos R; Device: Acryloc™ GHV

• Registration Number: NCT00208403
• Lead Sponsor: DePuy International

Brief Summary

The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

i) Male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg.

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 with non-inflammatory arthritis of the hip.

v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.

vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.

Exclusion Criteria

i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects undergoing corticosteroid treatment.

vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Palacos R	Palacos R
1	Acryloc™ GHV	Acryloc™ GHV

Primary Outcome Measures

Name	Time	Method
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment	2 Year

Secondary Outcome Measures

Name	Time	Method
Radiographic analysis	Annually
Kaplan-Meier Survivorship - Revision of any component for any reason	Throughout Study
Annual posterior (AP) and medio-lateral (ML) RSA translations	Annually
Merle D'Aubigne score	Annually

Trial Locations

Locations (1)

University Hospital of Trondheim; 🇳🇴 Trondheim, Sor-Trondelag, Norway