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

Osteoarthritis Clinical Trial

Official title:

Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00208403
• Other study ID #: CT02/08
• Status: Terminated
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 27, 2017
• Start date: October 2002
• Est. completion date: October 2005

Study information

• Verified date: March 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 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Avascular Necrosis
• Necrosis
• Osteoarthritis
• Post-traumatic Arthritis

Intervention

Device:
• Acryloc™ GHV
A high viscosity bone cement for use in total hip replacement
• Palacos R
A high viscosity bone cement for use in total hip replacement

Locations

Country	Name	City	State
Norway	University Hospital of Trondheim	Trondheim	Sor-Trondelag

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment		2 Year
Secondary	Annual posterior (AP) and medio-lateral (ML) RSA translations		Annually
Secondary	Merle D'Aubigne score		Annually
Secondary	Radiographic analysis		Annually
Secondary	Kaplan-Meier Survivorship - Revision of any component for any reason		Throughout Study