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Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00957970
Enrollment
120
Registered
2009-08-13
Start date
2006-07-31
Completion date
2009-07-31
Last updated
2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of Hip

Keywords

Stress shielding, Bone mineral density, stemless femoral component

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.

Interventions

DEVICEStemless femoral component

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

DEVICEIPS, Depuy cementless femoral stem

Anatomical proximal fitted cementless stemmed femoral component

Sponsors

Ewha Womans University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Bone mineral density of surrounding proximal femur according to Gruen zonesAt least 2years after surgery

Secondary

MeasureTime frame
Harris hip score2 years

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026