Osteoarthritis Clinical Trial
Official title:
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
NCT number | NCT01345097 |
Other study ID # | THRProxima |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2004 |
Est. completion date | March 2011 |
Verified date | April 2019 |
Source | Ewha Womans University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | March 2011 |
Est. primary completion date | March 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 95 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ewha Womans University Mokdong Hosptial | Seoul |
Lead Sponsor | Collaborator |
---|---|
Ewha Womans University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Harris hip score | This is a verified scoring tool for measuring hip function. | At least 5 years after surgery | |
Secondary | Improvement in the Range of Motion | The change in the hip range motion compared to the initial and the last measurement. | At least 5 years after surgery |
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