Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

This study has been completed.

Sponsor:

Information provided by:

Ewha Womans University

ClinicalTrials.gov Identifier:

NCT00957970

First received: July 21, 2009

Last updated: August 12, 2009

Last verified: August 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 21, 2009

Last Updated Date

August 12, 2009

Start Date ^ICMJE

July 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Bone mineral density of surrounding proximal femur according to Gruen zones [ Time Frame: At least 2years after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00957970 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Harris hip score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Official Title ^ICMJE

Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Brief Summary

The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.

Detailed Description

Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Osteoarthritis of Hip

Intervention ^ICMJE

Device: Stemless femoral component
Total hip femoral component anatomically designed for a proximal fit without a stem

Other Name: PROXIMA, DePuy stem,
Device: IPS, Depuy cementless femoral stem
Anatomical proximal fitted cementless stemmed femoral component

Other Name: IPS, Depuy anatomical proximal fit stemmed femoral component

Study Arm (s)

Active Comparator: Stemless femoral component
Stemless PROXIMA femoral component

Intervention: Device: Stemless femoral component
Active Comparator: Stemmed femoral component
IPS, proximal anatomical fit stemmed femoral component

Intervention: Device: IPS, Depuy cementless femoral stem

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

Completed

Enrollment ^ICMJE

120

Completion Date

July 2009

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

Neurologic disorders affecting motor function of lower extremity
foot and ankle disorders limiting ambulation of the patient
Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00957970

Other Study ID Numbers ^ICMJE

2009-7-17

Has Data Monitoring Committee

Yes

Responsible Party

Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center

Study Sponsor ^ICMJE

Ewha Womans University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Young-Hoo Kim, MD

Korean Joint replacement Center

Information Provided By

Ewha Womans University

Verification Date

August 2009

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

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