Taperloc Versus Taplerloc Microplasty

Ingemar Ivarsson60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis

Interventions

Taperloc MicroplastyDEVICE

primary total hip arthroplasty

Taperloc standardDEVICE

primary total hip arthroplasty

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University hospital of Linkoping

Linköping, Sweden

Outcomes

Primary Outcomes

Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:

Time frame: bone mineral density (BMD) measured postoperatively at 2 years

Secondary Outcomes

Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis

Time frame: 2 years

Data from ClinicalTrials.gov

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