Compaction Femur Preparation for Cementless Total Hip Arthroplasty (THA) Unilateral

Northern Orthopaedic Division, Denmark26 enrolled

Overview

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a hydroxylapatite (HA) coated titanium cementless femoral stem. Patients who receive a unilateral total hip replacement are randomized to either conventional broaching or compaction. Hypothesis: Compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (RSA)\], less peri-prosthetic bone mineral density (BMD) loss \[evaluated by dual energy x-ray absorptiometry (DEXA)\], and a higher Harris hip score after two years.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coxarthrosis

Interventions

Bone preparation technique: compactionPROCEDURE

The bone is pressed very hard together before implantation of femoral component.

Bone preparation technique: conventional techniquePROCEDURE

Bone is broached before implantation of femoral component.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with primary arthritis in the hip * Patients with sufficient bone density to allow uncemented implantation of a femoral component * Informed patient consent in writing Exclusion Criteria: * Patients with neuromuscular or vascular disease in the affected leg * Patients found upon operation to be unsuited for uncemented acetabulum component * Patients who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) and cannot interrupt intake for the postoperative phase of the study * Patients with fracture sequelae * Female patients of childbearing capacity * Hip joint dysplasia * Sequelae to previous hip joint disorder in childhood

Locations (1)

Northern Orthopaedic Division, Clinic Farsoe, Aalborg University Hospital

Farsø, Northern Jutland, Denmark

Outcomes

Primary Outcomes

To examine a possible difference in density of bones around implantation of femoral component.

A check-up by means of DEXA scanning after 1 week, 1 year, 2 years and 5 years.

Time frame: 5 years

Data from ClinicalTrials.gov

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