OsteoarthritisNCT00757107
Taperloc Versus Taplerloc Microplasty
A study testing Taperloc Microplasty and Taperloc standard in people with Osteoarthritis, run by Ingemar Ivarsson at 1 site in Sweden.
Trial summary
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Taperloc Microplasty and Taperloc standard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Jun 2015
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary osteoarthritis of the hip scheduled for THA.
- Suitable anatomy for both stems
- Willingness and ability to follow study-protocol
Who cannot join
- Malignancy or metastatic bone disease.
- Any other disease severely affecting bone and mineral metabolism
- Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
- Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
- Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
- Ongoing or previous treatment (within 5 years prior to inclusion) with anticonvulsive therapy.
- Ongoing or previous treatment (within 5 years prior to inclusion) with hormonal therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis
Read the detailed description
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.
Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.
- Conditions
- Osteoarthritis
- Being tested
- Taperloc Microplasty, Taperloc standard
- Keywords
- Short femoral stem, Stress shielding, Stem migration, Implant Survival, DEXA, Radiostereometric analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taperloc MicroplastyDevice
primary total hip arthroplasty
Taperloc standardDevice
primary total hip arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Taperloc Microplasty | Experimental | Patients with primary osteoarthritis with Taperloc microplasty non inferiority Receives: Device: Taperloc Microplasty |
| Taperloc Standard | Active comparator | Patients with primary osteoarthritis Taperloc standard Receives: Device: Taperloc standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:
Measured: bone mineral density (BMD) measured postoperatively at 2 years
Secondary outcomes (1)
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis
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 posted22 Sep 2008 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ingemar Ivarsson
- Sponsor type
- University, hospital or other
- Collaborators
- Biomet U.K. Ltd.
- Responsible party
- Sponsor-investigator, Ingemar Ivarsson, University Hospital, Linkoeping
- Investigators
- Ingemar IVARSSON, PhD, Principal investigator, University hospital of Linkoping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757107
- Sponsor's protocol ID
- GBMET.CR.ROWEU1
- Status last verified
- Mar 2016
- First submitted
- 19 Sep 2008
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Taperloc Total Hip System With Two Different Stem Lengths
- ClinicalTrials.gov ID
- NCT00757107
- Acronym / sponsor ID
- GBMET.CR.ROWEU1
- Conditions
- Osteoarthritis
- Keywords
- Short femoral stem, Stress shielding, Stem migration, Implant Survival, DEXA, Radiostereometric analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ingemar IvarssonUniversity, hospital or other
- Collaborators
- Biomet U.K. Ltd.
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Sep 2008 (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.
This evaluation is conducted to evaluate the safety and performance of two different stem lengths of the Taperloc Total Hip System. Per implant bone loss and migration of the stem are compared between the two groups with Dual-energy X-ray absorptiometry (DEXA) and radiostereomektric analysis
Detailed description
Consecutive patients between 50 - 70 years diagnosed with primary osteoarthritis of the hip and eligible for total hip arthroplasty will be asked to participate in the study.
Periprosthetic bone loss, migration of the components and clinical scores will be recorded prospectively at 3,6,12 and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taperloc Microplasty | Experimental | Device: Taperloc MicroplastyPatients with primary osteoarthritis with Taperloc microplasty non inferiority |
| Taperloc Standard | Active comparator | Device: Taperloc standardPatients with primary osteoarthritis Taperloc standard |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary osteoarthritis of the hip scheduled for THA.
- Suitable anatomy for both stems
- Willingness and ability to follow study-protocol
Key exclusion criteria (7 listed)
- Malignancy or metastatic bone disease.
- Any other disease severely affecting bone and mineral metabolism
- Ongoing or previous treatment (within 5 years prior to inclusion) with steroids
- Ongoing or previous treatment (within 5 years prior to inclusion) with antiresorptives.
- Ongoing or previous treatment (within 5 years prior to inclusion) with immunosuppressive drugs.
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 |
|---|---|---|
| Taperloc Microplastyprimary total hip arthroplasty | Device | Taperloc Microplasty |
| Taperloc standardprimary total hip arthroplasty | Device | Taperloc Standard |
Primary outcome
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame:
Time frame: bone mineral density (BMD) measured postoperatively at 2 years
1 secondary outcome
Migration of stem components in six degrees of freedom and maximum total point motion measured with radiostereometric analysis
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 14 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
Ingemar IVARSSON, PhD principal investigator
University hospital of Linkoping
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taperloc Microplasty and Taperloc standard in people with Osteoarthritis, run by Ingemar Ivarsson 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 7 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 14 Mar 2016. 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?
Bone remodelling, i e change in bone mineral density around the stem, as measured with dual energy x-ray absorptiometry (DEXA) [ Time Frame: (time frame: bone mineral density (BMD) measured postoperatively at 2 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 14 Mar 2016.