Compaction Total Hip Arthroplasty (THA) Bilateral

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Northern Orthopaedic Division, Denmark

ClinicalTrials.gov Identifier:

NCT00317889

First received: April 23, 2006

Last updated: December 27, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2006

Last Updated Date

December 27, 2010

Start Date ^ICMJE

January 2004

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00317889 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Compaction Total Hip Arthroplasty (THA) Bilateral

Official Title ^ICMJE

Compaction THA Bilateral

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

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Coxarthrosis

Intervention ^ICMJE

Procedure: Bone preparation technique: compaction
Procedure: Bone preparation technique: broaching

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2013

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT00317889

Other Study ID Numbers ^ICMJE

ON-04-002b-SKO

Has Data Monitoring Committee

Responsible Party

Northern Orthopaedic Division, Denmark

Study Sponsor ^ICMJE

Northern Orthopaedic Division, Denmark

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Søren Kold, MD

Northern Orthopaedic Division

Information Provided By

Northern Orthopaedic Division, Denmark

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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