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Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty

NCT ID: NCT01918540

Last Updated: 2014-11-26

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2014-11-30

Brief Summary

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The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.

Detailed Description

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Conditions

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Total Hip Arthroplasty

Keywords

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Radiostereometry Total Hip Arthroplasty Stem design

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Hollow Centralizer

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.

Group Type ACTIVE_COMPARATOR

Hollow Centralizer

Intervention Type PROCEDURE

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

MS-30 femoral stem

Intervention Type DEVICE

This is the stem used in the study.

Solid Centralizer

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer.

Group Type ACTIVE_COMPARATOR

Solid Centralizer

Intervention Type PROCEDURE

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

MS-30 femoral stem

Intervention Type DEVICE

This is the stem used in the study.

Interventions

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Hollow Centralizer

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

Intervention Type PROCEDURE

Solid Centralizer

The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer

Intervention Type PROCEDURE

MS-30 femoral stem

This is the stem used in the study.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary osteoarthritis of the hip necessitating primary hip replacement
* Charnley classification group A and B
* Age 60 - 85 years old at the inclusion time of the study.

Exclusion Criteria

* Secondary osteoarthritis
* Rheumatoid arthritis
* Malignant disease
* Severe osteoporosis
* Earlier fracture or operation in the hip to be operated on
* Peroperative fracture
* Ongoing corticosteroid (oral) or immunosuppressive medication
* Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Orthopedics, Skane University Hospital, Lund University

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Centralizer study

Identifier Type: -

Identifier Source: org_study_id