NCT03692351

Brief Summary

In order to investigate the role of acetabular cup screw holes for the transport of osteolysis-inducing particles in a total hip arthroplasty articulation, the investigators compare the amount of bone loss around acetabular cups with and without holes. Bone loss is measured with computed tomography at 7 years and 15 - 18 years of follow-up.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 1994

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 1994

Completed
22.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

22.6 years

First QC Date

August 20, 2018

Last Update Submit

September 30, 2018

Conditions

Arthroplasty Complications

Keywords

uncemented hip arthroplastyosteolysispolyethylene wearimplant design

Outcome Measures

Primary Outcomes (2)

  • Periacetabular osteolysis frequency change between 7 and 18 years

    Frequency of osteolysis (%) measured with computed tomography

    Change between 7 to 18 years after surgery

  • Periacetabular osteolysis size change between 7 and 18 years

    Size of periacetabular osteolysis (cm3) masured with computed tomography

    Change between 7 to 18 years after surgery

Secondary Outcomes (3)

  • Cup fixation (translation)

    18 years postoperatively

  • Cup fixation (rotation)

    18 years postoperatively

  • Polyethylene wear

    18 years postoperatively

Study Arms (2)

Cup with screw holes

ACTIVE COMPARATOR

Uncemented Trilogy cup (Zimmer, Warzaw, IN, US), screw fixation (2 or 3 screws)

Device: Uncemented acetabular cup with screw holes

Cup without screw holes

EXPERIMENTAL

Uncemented Trilogy cup (Zimmer, Warzaw, IN, US) without screw holes, press-fit fixation

Device: Uncemented acetabular cup without screw holes

Interventions

Uncemented acetabular cup with screw holesDEVICE
Cup with screw holes
Uncemented acetabular cup without screw holesDEVICE
Cup without screw holes

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary or secondary osteoarthritis

You may not qualify if:

  • Inflammatory osteoarthritis, hip joint infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteolysis

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 20, 2018

First Posted

October 2, 2018

Study Start

June 15, 1994

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share