NCT00214760

Brief Summary

The purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA centralizer during the placement of an uncemented Bihapro hip prosthesis.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Longer than P75 for phase_3

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

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 1, 2010

Status Verified

November 1, 2009

Enrollment Period

3.3 years

First QC Date

September 16, 2005

Last Update Submit

January 29, 2010

Conditions

Osteoarthritis

Keywords

Hip prosthesisCentralizerUncemented

Outcome Measures

Primary Outcomes (2)

  • Alignment

    0,3,6,12,24 months

  • Complications

    all time points

Secondary Outcomes (2)

  • Pain

    0,3,6,12,24 months

  • Function

    0,3,6,12,24 months

Study Arms (2)

PGET

EXPERIMENTAL
Device: PGET

PMMA

ACTIVE COMPARATOR
Device: PMMA

Interventions

PGETDEVICE

resolbable liner

Also known as: resolbable liner
PGET
PMMADEVICE

cement liner

Also known as: cement liner
PMMA

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years
  • Diagnosis: Osteoarthritis
  • Indicated for a primary hip prosthesis

You may not qualify if:

  • Previous hip surgery
  • No informed consent
  • Active infection in hip
  • Immature skeleton
  • Rheumatoid arthritis, M. Paget

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium medical centre

Heerlen, 6401CX, Netherlands

Location

Related Publications (1)

  • Hernandez-Vaquero D, Murcia-Mazon A, Paz-Jimenez J, Alegre-Mateo R, Martinez-Garcia J, Pena-Vazquez J. Behavior of the femoral stem in the Bihapro hip prosthesis. Orthopedics. 1999 Nov;22(11):1049-53. doi: 10.3928/0147-7447-19991101-13.

    PMID: 10580823RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Joanne Bloemsaat-Minekus, PhD

    Biomet Nederland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

May 1, 2005

Primary Completion

August 1, 2008

Study Completion

September 1, 2011

Last Updated

February 1, 2010

Record last verified: 2009-11

Locations

NL(1)