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Osteolysis Development Around Uncemented Cups With or Without Screw Holes

NCT ID: NCT03692351

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-06-15

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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Particles generated by wear and corrosion within an artificial hip articulation can cause biologically mediated bone loss in the surrounding pelvis. Particles can be found within immunologically active cells inside bone lesions. Holes intended for screw fixation in uncemented acetabular cups are believed to be a main route for these particles from the articulation into the pelvic bone. Using pressfit, screws are not always necessary for a successful fixation of an uncemented cup. The investigator's hypothesis is that a pressfit fixated cup without screw holes will display a decreased amount of periacetabular osteolysis compared to a cup with screw holes. Therefore, 95 hips (90 patients) were randomized to receive either pressfit cups without screw holes or the same type of cup with screw holes. The occurence and size of periacetabular osteolysis will be compared between the two groups. In addition, since the patients will have a computed tomography examination at 7 years and between 15 and 18 years the investigator will also analyze development of periacetabular osteolysis over time. The different cups were paired with three different types of femoral stems. Also, articulation wear and cup and stem fixation will be analyzed using radiostereometry.

Conditions

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Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cup with screw holes

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

Group Type ACTIVE_COMPARATOR

Uncemented acetabular cup with screw holes

Intervention Type DEVICE

Cup without screw holes

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

Group Type EXPERIMENTAL

Uncemented acetabular cup without screw holes

Intervention Type DEVICE

Interventions

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Uncemented acetabular cup with screw holes

Intervention Type DEVICE

Uncemented acetabular cup without screw holes

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* primary or secondary osteoarthritis

Exclusion Criteria

* Inflammatory osteoarthritis, hip joint infection
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Per-Erik Johanson

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Protesteam_Trilogy

Identifier Type: -

Identifier Source: org_study_id

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