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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01345097

Enrollment

200

Registered

2011-04-29

Start date

2004-05-31

Completion date

2011-03-31

Last updated

2019-05-01

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

Conditions

Osteoarthritis, Osteonecrosis

Keywords

short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient

Brief summary

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.

Detailed 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.

Interventions

DEVICETotal Hip Arthroplasty

Total Hip Arthroplasty

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Harris hip score	At least 5 years after surgery	This is a verified scoring tool for measuring hip function.

Secondary

Measure	Time frame	Description
Improvement in the Range of Motion	At least 5 years after surgery	The change in the hip range motion compared to the initial and the last measurement.

Countries

South Korea

Outcome results

None listed

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