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A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients

Ewha Womans University logo

Ewha Womans University

Status and phase

Completed
Phase 4

Conditions

Osteoarthritis
Osteonecrosis

Treatments

Device: Total Hip Arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT01345097
THRProxima

Details and patient eligibility

About

The investigators determined whether

  1. new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
  2. radiographically secure implant fixation is achieved with this new stem
  3. the bone content is preserved at the baseline level or above at the final follow-up
  4. these procedures are associated with early failure and complications.

Full description

To attempt reduction of stress shielding and thigh pain as well as to improve survivorship, a new short, metaphyseal-fitting cementless anatomical femoral stem was developed. The question arises as to whether it is possible to obtain rigid fixation of the stem without diaphyseal fixation in the young as well as in the elderly patients. The purpose of this study was to determine the clinical and radiographic results of the new short, metaphyseal-fitting cementless anatomical femoral stem in the young as well as in the elderly patients.

Enrollment

200 patients

Sex

All

Ages

20 to 95 years old

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

200 participants in 2 patient groups

Younger Group
Experimental group
Treatment:
Device: Total Hip Arthroplasty
Elderly Group
Experimental group
Treatment:
Device: Total Hip Arthroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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