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Completed

NCT Number: NCT00957970

Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

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.

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Key information

Conditions

Osteoarthritis of Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ewha Womans University Mokdong Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stemless femoral component

Device

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

Other names: PROXIMA, DePuy stem,

IPS, Depuy cementless femoral stem

Device

Anatomical proximal fitted cementless stemmed femoral component

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

Primary outcomes

  1. Bone mineral density of surrounding proximal femur according to Gruen zones

    Time frame: At least 2years after surgery

Secondary outcomes

  1. Harris hip score

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Important dates

Study start
2006
Primary completion
2007
Study completion
2009
First posted
Aug 13, 2009
Registry last updated
Aug 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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