Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

NCT ID: NCT00957970

Last Updated: 2009-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Stemless femoral component

Stemless PROXIMA femoral component

Group Type ACTIVE_COMPARATOR

Stemless femoral component

Intervention Type DEVICE

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

Stemmed femoral component

IPS, proximal anatomical fit stemmed femoral component

Group Type ACTIVE_COMPARATOR

IPS, Depuy cementless femoral stem

Intervention Type DEVICE

Anatomical proximal fitted cementless stemmed femoral component

Interventions

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Stemless femoral component

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

Intervention Type DEVICE

IPS, Depuy cementless femoral stem

Anatomical proximal fitted cementless stemmed femoral component

Intervention Type DEVICE

Other Intervention Names

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PROXIMA, DePuy stem, IPS, Depuy anatomical proximal fit stemmed femoral component

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ewha Womans University

OTHER

Sponsor Role lead

Responsible Party

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Ewha Womans University Mokdong Hospital Joint Replacement Center

Principal Investigators

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Young-Hoo Kim, MD

Role: STUDY_DIRECTOR

Korean Joint replacement Center

Locations

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Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.

Reference Type BACKGROUND
PMID: 17377765 (View on PubMed)

Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.

Reference Type BACKGROUND
PMID: 19562565 (View on PubMed)

Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.

Reference Type BACKGROUND
PMID: 18983669 (View on PubMed)

Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.

Reference Type BACKGROUND
PMID: 12375241 (View on PubMed)

Other Identifiers

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2009-7-17

Identifier Type: -

Identifier Source: org_study_id

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