Back to resultsA Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Primary Purpose
Osteonecrosis, Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteonecrosis focused on measuring short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient
Eligibility 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.
Sites / Locations
- Ewha Womans University Mokdong Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Younger Group
Elderly Group
Arm Description
Outcomes
Primary Outcome Measures
Harris hip score
This is a verified scoring tool for measuring hip function.
Secondary Outcome Measures
Improvement in the Range of Motion
The change in the hip range motion compared to the initial and the last measurement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01345097
Brief Title
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Official Title
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators determined whether
new short, metaphyseal-fitting cementless anatomical femoral stem provides major functional improvements
radiographically secure implant fixation is achieved with this new stem
the bone content is preserved at the baseline level or above at the final follow-up
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteonecrosis, Osteoarthritis
Keywords
short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Younger Group
Arm Type
Experimental
Arm Title
Elderly Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty
Other Intervention Name(s)
Proxima
Intervention Description
Total Hip Arthroplasty
Primary Outcome Measure Information:
Title
Harris hip score
Description
This is a verified scoring tool for measuring hip function.
Time Frame
At least 5 years after surgery
Secondary Outcome Measure Information:
Title
Improvement in the Range of Motion
Description
The change in the hip range motion compared to the initial and the last measurement.
Time Frame
At least 5 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Hoo Kim, MD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ewha Womans University Mokdong Hosptial
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
12. IPD Sharing Statement
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A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
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