Compaction Total Hip Arthroplasty (THA) Bilateral

Northern Orthopaedic Division, Denmark20 enrolled

Overview

This is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. Patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side. 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

Bone preparation technique: broachingPROCEDURE

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

Aalborg and Farsø, Aalborg, Denmark

Outcomes

Primary Outcomes

Radiostereometric analysis

Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis

Time frame: 5 and 10 years follow-up

Secondary Outcomes

Periprosthetic bone mineral density

Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)

Time frame: 5 years follow-up

Data from ClinicalTrials.gov

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