Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Ewha Womans University

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis of Hip

Treatments: Device: Stemless femoral component; Device: IPS, Depuy cementless femoral stem

Study type: Interventional

Funder types: Other

Identifiers

NCT00957970

2009-7-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

Stemless femoral component

Active Comparator group

Description:

Stemless PROXIMA femoral component

Treatment:

Device: Stemless femoral component

Stemmed femoral component

Active Comparator group

Description:

IPS, proximal anatomical fit stemmed femoral component

Treatment:

Device: IPS, Depuy cementless femoral stem