Taperloc Versus Taplerloc Microplasty

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

2011-10-31

Study Completion Date

2015-06-30

Brief Summary

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This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis

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Detailed Description

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Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.

Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.

Conditions

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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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Taperloc Microplasty

Patients with primary osteoarthritis with Taperloc microplasty non inferiority

Group Type EXPERIMENTAL

Taperloc Microplasty

Intervention Type DEVICE

primary total hip arthroplasty

Taperloc Standard

Patients with primary osteoarthritis Taperloc standard

Group Type ACTIVE_COMPARATOR

Taperloc standard

Intervention Type DEVICE

primary total hip arthroplasty

Interventions

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Taperloc Microplasty

primary total hip arthroplasty

Intervention Type DEVICE

Taperloc standard

primary total hip arthroplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with primary osteoarthritis of the hip scheduled for THA.
* Suitable anatomy for both stems
* Willingness and ability to follow study-protocol

Exclusion Criteria

* Malignancy or metastatic bone disease.
* Any other disease severely affecting bone and mineral metabolism
* Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
* Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
* Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
* Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
* Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No