Prospective Randomised Study of a New an Uncemented Stem.

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2019-05-31

Brief Summary

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Patients will be randomised to either operation with a Corail stem or a SP-CL stem. The groups are examined with RSA, conventional x-rays, PROM-data and DXA. First evaluation will be done at two years.

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Detailed Description

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Conditions

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Hip Osteoarthritis

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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SP-CL

Group Type ACTIVE_COMPARATOR

Hip Arthroplasty

Intervention Type DEVICE

Patients are operated with hip replacement.

Corail

Group Type ACTIVE_COMPARATOR

Hip Arthroplasty

Intervention Type DEVICE

Patients are operated with hip replacement.

Interventions

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Hip Arthroplasty

Patients are operated with hip replacement.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primary osteoartritis Secondary osteoartritis

Exclusion Criteria

* Ongoing treatment with corticoid steroids, Active cancer disease, previously known osteoporosis or osteomalacia, inflammatory arthritis, unsuitable anatomy, difficulties to speak or understand the Swedish language.

Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No