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

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT01345097
First received: April 27, 2011
Last updated: April 28, 2011
Last verified: March 2011
  Purpose

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.

Condition Intervention Phase
Osteonecrosis
Osteoarthritis
Device: Total Hip Arthroplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients

Resource links provided by NLM:


Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Harris hip score [ Time Frame: At least 5 years after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the Range of Motion [ Time Frame: At least 5 years after surgery ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 2004
Study Completion Date: March 2011
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Younger Group Device: Total Hip Arthroplasty
Total Hip Arthroplasty
Other Name: Proxima
Experimental: Elderly Group Device: Total Hip Arthroplasty
Total Hip Arthroplasty
Other Name: Proxima

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01345097

Locations
Korea, Republic of
Ewha Womans University Mokdong Hosptial
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University
Investigators
Study Director: Young-Hoo Kim, MD Ewha Womans University Mokdong Hospital
  More Information

No publications provided

Responsible Party: Young-Hoo Kim, M.D. Professor, Ewha Womans University Mokdong Hospital Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01345097     History of Changes
Other Study ID Numbers: THRProxima
Study First Received: April 27, 2011
Last Updated: April 28, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
short, metaphyseal-fitting femoral stem
cementless anatomical femoral stem
young patient
elderly patient

Additional relevant MeSH terms:
Osteoarthritis
Osteonecrosis
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014