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Osteolysis Development Around Uncemented Cups With or Without Screw Holes

NCT03692351 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2018-10-02

No results posted yet for this study

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.

Conditions

  • Arthroplasty Complications

Interventions

DEVICE

Uncemented acetabular cup with screw holes

DEVICE

Uncemented acetabular cup without screw holes

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1994-06-15
Primary Completion
2016-12-31
Completion
2016-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03692351 on ClinicalTrials.gov