Osteoarthritis of HipPhase 4NCT00957970
Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
A Phase 4 study testing Stemless femoral component and IPS, Depuy cementless femoral stem in people with Osteoarthritis of Hip, run by Ewha Womans University at 1 site in South Korea.
Trial summary
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis of Hip
- What is being tested?
- Stemless femoral component and IPS, Depuy cementless femoral stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2006to Jul 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, 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
Official title: Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
Read the detailed description
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
- Conditions
- Osteoarthritis of Hip
- Being tested
- Stemless femoral component, IPS, Depuy cementless femoral stem
- Keywords
- Stress shielding, Bone mineral density, stemless femoral component
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stemless femoral componentDevice
Also called PROXIMA, DePuy stem,
Total hip femoral component anatomically designed for a proximal fit without a stem
IPS, Depuy cementless femoral stemDevice
Also called IPS, Depuy anatomical proximal fit stemmed femoral component
Anatomical proximal fitted cementless stemmed femoral component
| Study group | Role | What they receive |
|---|---|---|
| Stemless femoral component | Active comparator | Stemless PROXIMA femoral component Receives: Device: Stemless femoral component |
| Stemmed femoral component | Active comparator | IPS, proximal anatomical fit stemmed femoral component Receives: Device: IPS, Depuy cementless femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density of surrounding proximal femur according to Gruen zones
Measured: At least 2years after surgery
Secondary outcomes (1)
Harris hip score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJul 2006
- Primary completionJul 2007
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of HipStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University
- Sponsor type
- University, hospital or other
- Investigators
- Young-Hoo Kim, MD, Study director, Korean Joint replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957970
- Sponsor's protocol ID
- 2009-7-17
- Status last verified
- Aug 2009
- First submitted
- 21 Jul 2009
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.
PubMed 17377765Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.
PubMed 19562565Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.
PubMed 18983669Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.
PubMed 12375241
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
- ClinicalTrials.gov ID
- NCT00957970
- Acronym / sponsor ID
- 2009-7-17
- Conditions
- Osteoarthritis of Hip
- Keywords
- Stress shielding, Bone mineral density, stemless femoral component
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ewha Womans UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 Aug 2009 (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 purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
Detailed description
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
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 |
|---|---|---|
| Stemless femoral component | Active comparator | Device: Stemless femoral componentStemless PROXIMA femoral component |
| Stemmed femoral component | Active comparator | Device: IPS, Depuy cementless femoral stemIPS, proximal anatomical fit stemmed femoral component |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoarthritis of hip joint requiring total hip arthroplasty
Key exclusion criteria (4 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 |
|---|---|---|
| Stemless femoral componentAlso: PROXIMA, DePuy stem,Total hip femoral component anatomically designed for a proximal fit without a stem | Device | Stemless femoral component |
| IPS, Depuy cementless femoral stemAlso: IPS, Depuy anatomical proximal fit stemmed femoral componentAnatomical proximal fitted cementless stemmed femoral component | Device | Stemmed femoral component |
Primary outcome
Bone mineral density of surrounding proximal femur according to Gruen zones
Time frame: At least 2years after surgery
1 secondary outcome
Harris hip score
Time frame: 2 years
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 13 Aug 2009.
- Background: PubMed 17377765Gulow J, Scholz R, Freiherr von Salis-Soglio G. [Short-stemmed endoprostheses in total hip arthroplasty]. Orthopade. 2007 Apr;36(4):353-9. doi: 10.1007/s00132-007-1071-x. German.
- Background: PubMed 19562565Albanese CV, Santori FS, Pavan L, Learmonth ID, Passariello R. Periprosthetic DXA after total hip arthroplasty with short vs. ultra-short custom-made femoral stems: 37 patients followed for 3 years. Acta Orthop. 2009 Jun;80(3):291-7. doi: 10.3109/17453670903074467.
- Background: PubMed 18983669Renkawitz T, Santori FS, Grifka J, Valverde C, Morlock MM, Learmonth ID. A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial. BMC Musculoskelet Disord. 2008 Nov 4;9:147. doi: 10.1186/1471-2474-9-147.
- Background: PubMed 12375241Kim YH. Cementless total hip arthroplasty with a close proximal fit and short tapered distal stem (third-generation) prosthesis. J Arthroplasty. 2002 Oct;17(7):841-50. doi: 10.1054/arth.2002.33555.
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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
Korean Joint replacement Center
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 Stemless femoral component and IPS, Depuy cementless femoral stem in people with Osteoarthritis of Hip, 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 4 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 13 Aug 2009. 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?
Bone mineral density of surrounding proximal femur according to Gruen zones (time frame: At least 2years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957970, which also lists 4 linked publications.
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 13 Aug 2009.