OsteonecrosisPhase 4NCT01345097
A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
A Phase 4 study testing Total Hip Arthroplasty in people with Osteonecrosis and Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Osteonecrosis, Osteoarthritis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2004to Mar 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of hip joint requiring total hip arthroplasty
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Osteonecrosis, Osteoarthritis
- Being tested
- Total Hip Arthroplasty
- Keywords
- short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient
- Medical subject headings
- Osteonecrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
Also called Proxima
Total Hip Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Younger Group | Experimental | Not described Receives: Device: Total Hip Arthroplasty |
| Elderly Group | Experimental | Not described Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris hip score
This is a verified scoring tool for measuring hip function.
Measured: At least 5 years after surgery
Secondary outcomes (1)
Improvement in the Range of Motion
The change in the hip range motion compared to the initial and the last measurement.
Measured: At least 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startMay 2004
- Primary completionMar 2006
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Hoo Kim, Ewha Womans University
- Investigators
- Young-Hoo Kim, MD, Study director, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345097
- Sponsor's protocol ID
- THRProxima
- Status last verified
- Apr 2019
- First submitted
- 27 Apr 2011
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Metaphyseal Fitting Total Hip Arthroplasty in Young and Elderly Patients
- ClinicalTrials.gov ID
- NCT01345097
- Acronym / sponsor ID
- THRProxima
- Conditions
- Osteonecrosis, Osteoarthritis
- Keywords
- short, metaphyseal-fitting femoral stem, cementless anatomical femoral stem, young patient, elderly patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger Group | Experimental | Device: Total Hip Arthroplasty |
| Elderly Group | Experimental | Device: Total Hip Arthroplasty |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of hip joint requiring total hip arthroplasty
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip ArthroplastyAlso: ProximaTotal Hip Arthroplasty | Device | Elderly Group, Younger Group |
Primary outcome
Harris hip score
Time frame: At least 5 years after surgery
This is a verified scoring tool for measuring hip function.
1 secondary outcome
Improvement in the Range of Motion
Time frame: At least 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Hoo Kim, MD study director
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total Hip Arthroplasty in people with Osteonecrosis and Osteoarthritis, run by Ewha Womans University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harris hip score (time frame: At least 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.