NCT01098604

Brief Summary

It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings. The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results. The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2010

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2010

Enrollment Period

1.5 years

First QC Date

April 1, 2010

Last Update Submit

March 19, 2014

Conditions

Arthroplasty, Replacement, Hip

Outcome Measures

Primary Outcomes (6)

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    6 weeks

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    3 months

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    6 months

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    9 months

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    12 months

  • rate of dislocation in each head size

    to evaluate the null hypothesis that the dislocation rate of larger ceramic head group is similar to smaller ceramic head group.

    24 months

Secondary Outcomes (6)

  • clinical results using Harris Hip Score

    6 weeks

  • clinical results using Harris Hip Score

    3 months

  • clinical results using Harris Hip Score

    6 months

  • clinical results using Harris Hip Score

    9 months

  • clinical results using Harris Hip Score

    12 months

  • +1 more secondary outcomes

Study Arms (2)

32mm ceramic head group

ACTIVE COMPARATOR

patients performed with THA using 32mm ceramic head

Device: 32mm ceramic head group

28mm ceramic head group

ACTIVE COMPARATOR

patients performed with THA using 28mm ceramic head

Device: 28mm ceramic head group

Interventions

32mm ceramic head groupDEVICE

we performed THA using 32mm ceramic head in this group.

32mm ceramic head group
28mm ceramic head groupDEVICE

we performed THA using 28mm ceramic head in this group.

28mm ceramic head group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteonecrosis of femoral head
  • primary or secondary osteoarthritis of the hips
  • femoral neck fracture

You may not qualify if:

  • previous hemi- or total hip arthroplasty
  • highly dislocated or severe ankylosed hip
  • patients who are considered potentially unreliable or who may not reliably attend study visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

  • Kyung-Hoi Koo, professor

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2010

First Posted

April 5, 2010

Study Start

May 1, 2006

Primary Completion

November 1, 2007

Study Completion

December 1, 2009

Last Updated

March 20, 2014

Record last verified: 2010-03

Locations

KR(1)