Compaction Total Hip Arthroplasty (THA) Bilateral

Not Applicable

Completed

• Conditions: Coxarthrosis

• Registration Number: NCT00317889
• Lead Sponsor: Northern Orthopaedic Division, Denmark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2006-04-23
• Study First Submitted QC: 2006-04-24
• Study First Posted: 2006-04-25
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Radiostereometric analysis	5 and 10 years follow-up	Stem subsidence (change) at 5 and 10 years measured with radiostereometric analysis

Secondary Outcome Measures

Name	Time	Method
Periprosthetic bone mineral density	5 years follow-up	Periprosthetic bone mineral density measured with Dual Energy X-ray Absorptiometry (DXA)

Trial Locations

Locations (1)

Northern Orthopaedic Division; 🇩🇰 Aalborg And Farsø, Aalborg, Denmark