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

NCT00318396 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2017-04-12

No results posted yet for this study

Summary

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.

Conditions

  • Coxarthrosis

Interventions

PROCEDURE

Bone preparation technique: compaction

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

PROCEDURE

Bone preparation technique: conventional technique

Bone is broached before implantation of femoral component.

Sponsors & Collaborators

  • Northern Orthopaedic Division, Denmark

    lead OTHER

Principal Investigators

  • Soeren Kold, MD · Northern Orthopaedic Division

  • Kjeld Soeballe, MD, Prof. · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318396 on ClinicalTrials.gov