NCT01806766

Brief Summary

The purpose of this prospective, randomized study was to compare the clinical and radiographic results and the prevalence of osteolysis of the cementless total hip arthroplasty with an alumina-on-alumina bearings one side and alumina-on-highly cross-linked polyethylene bearings on the other side in the young and active patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 1998

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

January 1, 1998

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

2 years

First QC Date

March 5, 2013

Last Update Submit

March 6, 2013

Conditions

OsteonecrosisOsteoarthritis

Keywords

cementless total hip arthroplastyceramic on ceramic bearingceramic on highly cross linked polyethyleneyoung patient

Outcome Measures

Primary Outcomes (1)

  • Harris hip score

    Comparing harris hip score before and after the intervention, and at the final follow-up, between two sides.

    Pre-op, last follow-up(11-13 years)

Secondary Outcomes (1)

  • Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

    preop, last follow-up(11-13 years)

Study Arms (2)

Ceramic on Ceramic

ACTIVE COMPARATOR

Ceramic on Ceramic bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Procedure: Ceramic on Ceramic bearing

Ceramic on HXPE

ACTIVE COMPARATOR

Ceramic on HIghly crosslinked polyethylene bearing coupled side of a single patient undergoing bilateral total hip arthroplasty

Procedure: Ceramic on Highly crosslinked polyethylene bearing

Interventions

Ceramic on Ceramic bearingPROCEDURE

cementless Total Hip Arthroplasty with Ceramic on ceramic bearing

Ceramic on Ceramic
Ceramic on Highly crosslinked polyethylene bearingPROCEDURE

Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing

Ceramic on HXPE

Eligibility Criteria

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

You may qualify if:

  • Primary hip osteoarthritis
  • Secondary hip osteoarthritis
  • Avascular necrosis of femoral head

You may not qualify if:

  • Previous surgical history of hip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 158-710, South Korea

Location

MeSH Terms

Conditions

OsteonecrosisOsteoarthritis

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesRheumatic Diseases

Study Officials

  • Young-Hoo Kim, MD

    Ewha Womans University Mokdong Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

January 1, 1998

Primary Completion

January 1, 2000

Study Completion

December 1, 2012

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

KR(1)