NCT00208403

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2002

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

September 13, 2005

Last Update Submit

March 27, 2017

Conditions

OsteoarthritisPost-traumatic ArthritisAvascular Necrosis

Keywords

HipCement

Outcome Measures

Primary Outcomes (1)

  • Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment

    2 Year

Secondary Outcomes (4)

  • Annual posterior (AP) and medio-lateral (ML) RSA translations

    Annually

  • Merle D'Aubigne score

    Annually

  • Radiographic analysis

    Annually

  • Kaplan-Meier Survivorship - Revision of any component for any reason

    Throughout Study

Study Arms (2)

1

ACTIVE COMPARATOR

Acryloc™ GHV

Device: Acryloc™ GHV

2

ACTIVE COMPARATOR

Palacos R

Device: Palacos R

Interventions

Acryloc™ GHVDEVICE

A high viscosity bone cement for use in total hip replacement

1
Palacos RDEVICE

A high viscosity bone cement for use in total hip replacement

2

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Trondheim

Trondheim, Sor-Trondelag, Norway

Location

MeSH Terms

Conditions

OsteoarthritisOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

October 1, 2002

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

NO(1)