Hip OsteoarthritisPhase 4NCT02321683
Evaluation of a New Coating in Cement Less Femoral Stems
A Phase 4 study testing Taperloc in people with Hip Osteoarthritis, run by Lars Nordsletten.
Trial summary
The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- Taperloc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2008
- 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
- non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants
Who cannot join
- infection, revision surgery, severe morbidity and obvious bone loss
About this study
Official title: No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
The purpose of this trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
Read the detailed description
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.
- Conditions
- Hip Osteoarthritis
- Being tested
- Taperloc
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaperlocDevice
Femoral stem with electrochemical deposition of hydroxyapatite
| Study group | Role | What they receive |
|---|---|---|
| Bonemaster | Experimental | Cement-less femoral stems with electrochemical deposition of hydroxyapatite Receives: Device: Taperloc |
| Hydroxyapatite | Active comparator | Cement-less femoral stems with plasmasprayed hydroxyapatite Receives: Device: Taperloc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early and intermediate periprosthetic bone remodeling
Bone densitometry measured by DXA
Measured: 5 years
Early and intermediate femoral stem stability
Radiostereometric analysis of femoral stem movements relative to bone
Measured: 5 years
Secondary outcomes (2)
Clinical function
Hip questionares, Harris Hip Score and Oxford Hip Score
Measured: 5 years
Radiographic signs of loosening
Conventional x-ray
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startDec 2003
- Primary completionJun 2005
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Nordsletten
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor-investigator, Lars Nordsletten, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321683
- Sponsor's protocol ID
- ORTHO.CR.GH30.
- Status last verified
- Dec 2014
- First submitted
- 17 Dec 2014
- Last updated
- 22 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.
PubMed 26364953
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No Mid-term Advantage by Electrochemical Deposition of Hydroxyl-apatite in Cementless Femoral Stems. 5-year RSA and DXA Results From a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02321683
- Acronym / sponsor ID
- ORTHO.CR.GH30.
- Conditions
- Hip Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Lars NordslettenUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Dec 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Dec 2014 (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 trial is to evaluate a new method of applying hydroxyapatite coatings on cement-less femoral stems.
Detailed description
60 patients eligible for total hip replacement will be randomized in to two groups, receiving either femoral stems with plasma sprayed hydroxyapatite coating or stems with electrochemically deposited hydroxyapatite. This patients will be followed for at least 5 years. The outcome is evaluated by comparing stability measured by RSA and periprosthetic bone remodeling measured by bone densitometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bonemaster | Experimental | Device: TaperlocCement-less femoral stems with electrochemical deposition of hydroxyapatite |
| Hydroxyapatite | Active comparator | Device: TaperlocCement-less femoral stems with plasmasprayed hydroxyapatite |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- non-inflammatory hip arthritis, life expectancy of at least 10 years and hip anatomy allowing the use of standard implants
Key exclusion criteria (1 listed)
- infection, revision surgery, severe morbidity and obvious bone loss
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 |
|---|---|---|
| TaperlocFemoral stem with electrochemical deposition of hydroxyapatite | Device | Bonemaster, Hydroxyapatite |
Primary outcome
Early and intermediate periprosthetic bone remodeling
Time frame: 5 years
Bone densitometry measured by DXA
Early and intermediate femoral stem stability
Time frame: 5 years
Radiostereometric analysis of femoral stem movements relative to bone
2 secondary outcomes
Clinical function
Time frame: 5 years
Radiographic signs of loosening
Time frame: 5 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 22 Dec 2014.
- Derived from this study: PubMed 26364953Flatoy B, Rohrl SM, Boe B, Nordsletten L. No medium-term advantage of electrochemical deposition of hydroxyapatite in cementless femoral stems. 5-year RSA and DXA results from a randomized controlled trial. Acta Orthop. 2016 Feb;87(1):42-7. doi: 10.3109/17453674.2015.1084768. Epub 2015 Sep 12.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Taperloc in people with Hip Osteoarthritis, run by Lars Nordsletten.
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 1 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 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Early and intermediate periprosthetic bone remodeling (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02321683, which also lists 1 linked publication.
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 22 Dec 2014.