Total Hip ArthroplastyNCT01918540
Importance of Hollow or Solid Centralizer for Polished, Collarless and Tapered Stems in Total Hip Arthroplasty
A study testing Hollow Centralizer, Solid Centralizer and MS-30 femoral stem in people with Total Hip Arthroplasty, run by Region Skane at 1 site in Sweden.
Trial summary
The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Hollow Centralizer, Solid Centralizer and MS-30 femoral stem
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2003to Nov 2014
- Phase
- Interventional
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the hip necessitating primary hip replacement
- Charnley classification group A and B
- Age 60 - 85 years old at the inclusion time of the study.
Who cannot join
- Secondary osteoarthritis
- Rheumatoid arthritis
- Malignant disease
- Severe osteoporosis
- Earlier fracture or operation in the hip to be operated on
- Peroperative fracture
- Ongoing corticosteroid (oral) or immunosuppressive medication
- Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Orthopedics, Skane University Hospital, Lund University
Lund, Skåne County, 221 85
About this study
Official title: Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).
The study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Hollow Centralizer, Solid Centralizer, MS-30 femoral stem
- Keywords
- Radiostereometry, Total Hip Arthroplasty, Stem design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hollow CentralizerProcedure or surgery
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
Solid CentralizerProcedure or surgery
The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
MS-30 femoral stemDevice
This is the stem used in the study.
| Study group | Role | What they receive |
|---|---|---|
| Hollow Centralizer | Active comparator | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. Receives: Procedure: Hollow Centralizer; Device: MS-30 femoral stem |
| Solid Centralizer | Active comparator | The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. Receives: Procedure: Solid Centralizer; Device: MS-30 femoral stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiostereometric Analysis (RSA)
This will measure the change in stem migration over time and be indicative of long term result.
Measured: The first postoperative day, 6 months, 1, 2, 5 and 10 years
Secondary outcomes (3)
x-ray
On standard x-rays the progress of radiolucent lines or other signs of loosening will be measured
Measured: The first postoperative day, 6 months, 1, 2, 5 and 10 years
Hip specific questionnaire
Hip disability and Osteoarthritis Score (HOOS) - this is a hip specific questionnaire that will measure how the operation has affected the patients hip function and pain situation
Measured: Preoperatively, 1, 2, 5 and 10 years
General health questionnaire
EuroQol (EQ-5D) - a standardized instrument for use as measure of general health outcome
Measured: Preoperatively, 1, 2, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startFeb 2003
- Primary completionFeb 2004
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918540
- Sponsor's protocol ID
- Centralizer study
- Status last verified
- Nov 2014
- First submitted
- 4 Jul 2013
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Hollow and Solid Centralizer Designs When Using a Polished, Collarless, Tapered Hip Prosthesis Stem (MS30). A Prospective, Randomized, Multicenter Study Evaluated by RadioStereometric Analysis (RSA).
- ClinicalTrials.gov ID
- NCT01918540
- Acronym / sponsor ID
- Centralizer study
- Conditions
- Total Hip Arthroplasty
- Keywords
- Radiostereometry, Total Hip Arthroplasty, Stem design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Feb 2003
- Primary completion
- Feb 2004 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Aug 2013 (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 study aims at comparing the effect of hollow or solid centralizer designs on the long time fixation behaviour of hip prosthesis stems that are polished, tapered and collarless. In a prospective, controlled and randomized study comprising two groups of 30 patients/hips each, the patients will be followed up by RadioStereometric Analysis (RSA) for ten years. In completion general health questionnaires as well as hip specific scoring instruments will be used to evaluate patient satisfaction and outcome.The hypothesis of the study is that the different centralizers will result in different migration patterns of the stems, which might affect the risk for late aseptic loosening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hollow Centralizer | Active comparator | Procedure: Hollow Centralizer, Device: MS-30 femoral stemThe stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. |
| Solid Centralizer | Active comparator | Procedure: Solid Centralizer, Device: MS-30 femoral stemThe stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary osteoarthritis of the hip necessitating primary hip replacement
- Charnley classification group A and B
- Age 60 - 85 years old at the inclusion time of the study.
Key exclusion criteria (8 listed)
- Secondary osteoarthritis
- Rheumatoid arthritis
- Malignant disease
- Severe osteoporosis
- Earlier fracture or operation in the hip to be operated on
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 |
|---|---|---|
| Hollow CentralizerThe stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer | Procedure or surgery | Hollow Centralizer |
| Solid CentralizerThe stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer | Procedure or surgery | Solid Centralizer |
| MS-30 femoral stemThis is the stem used in the study. | Device | Hollow Centralizer, Solid Centralizer |
Primary outcome
Radiostereometric Analysis (RSA)
Time frame: The first postoperative day, 6 months, 1, 2, 5 and 10 years
This will measure the change in stem migration over time and be indicative of long term result.
3 secondary outcomes
x-ray
Time frame: The first postoperative day, 6 months, 1, 2, 5 and 10 years
Hip specific questionnaire
Time frame: Preoperatively, 1, 2, 5 and 10 years
General health questionnaire
Time frame: Preoperatively, 1, 2, 5 and 10 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 26 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hollow Centralizer, Solid Centralizer and MS-30 femoral stem in people with Total Hip Arthroplasty, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 8 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 26 Nov 2014. 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 Sweden. 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.
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?
Radiostereometric Analysis (RSA) (time frame: The first postoperative day, 6 months, 1, 2, 5 and 10 years). 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 26 Nov 2014.