CoxarthrosisNCT00722982
Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
An observational study of Coxarthrosis, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coxarthrosis
- How many people
- 70 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2008to Jul 2015
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 patients admitted to orthopedic clinic Ringerike hospital for coxarthrosis are planned to be included in stydy. The all should agree in a written form to participate in study. They are randomized to be operated THA with Exeter- or C-stem AMT femur prostesis. Marathon acetabular prosthesis will be used for all patients included.
Who may be able to join
- coxarthrosis
Who cannot join
- age over 80
- major medial condition such as renal failure, chronic obstructive lung disease heart failure etc
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis
In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.
The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years
- Conditions
- Coxarthrosis
- Keywords
- coxarthrosis, hip, RSA, DXA, C-stem AMT, Marathon
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of femur- and acetabular prosthesis measured by RSA
Measured: 2008-2012
Secondary outcomes (1)
Periprosthetic osteolysis of proximal femur
Measured: 2008-2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMay 2012
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoxarthrosisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ringerike hospital HF, Hønefoss Norway, Ortomedic AS, Lysaker Norway, Helse Sor-Ost
- Responsible party
- Sponsor
- Investigators
- Lars Nordsletten, Professor, Study chair, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722982
- Sponsor's protocol ID
- C-stem AMT
- Status last verified
- Nov 2014
- First submitted
- 25 Jul 2008
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migration Pattern of C-stem AMT Versus Exeter in Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00722982
- Acronym / sponsor ID
- C-stem AMT
- Conditions
- Coxarthrosis
- Keywords
- coxarthrosis, hip, RSA, DXA, C-stem AMT, Marathon
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- Ringerike hospital HF, Hønefoss Norway, Ortomedic AS, Lysaker Norway, Helse Sor-Ost
- Study start
- Jul 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2015 (estimated)
- First posted
- 28 Jul 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.
Hypothesis: Migration of C-Stem AMT is equal to the well documented Exeter prosthesis
In Norway it is annually performed approximately 600 primary and 100 revisions THA. Osteolysis around the prosthesis is one of the major difficulties while performing revision surgery. C-stem is a triple tapered cemented prosthesis designed to increase the stress and strain of proximal femur and thereby decreasing osteolysis. We are planning til include 70 patients and randomize to C-stem AMT or Exeter prosthesis. Both prosthesis will be combined with previously non documented "Marathon" acetabular prosthesis.
The result will be followed clinically and with RSA and DXA. Soft endpoint after 2 years
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 patients admitted to orthopedic clinic Ringerike hospital for coxarthrosis are planned to be included in stydy. The all should agree in a written form to participate in study. They are randomized to be operated THA with Exeter- or C-stem AMT femur prostesis. Marathon acetabular prosthesis will be used for all patients included.
Key inclusion criteria (1 listed)
- coxarthrosis
Key exclusion criteria (2 listed)
- age over 80
- major medial condition such as renal failure, chronic obstructive lung disease heart failure etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Migration of femur- and acetabular prosthesis measured by RSA
Time frame: 2008-2012
1 secondary outcome
Periprosthetic osteolysis of proximal femur
Time frame: 2008-2012
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 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.
Lars Nordsletten, Professor study chair
Ullevaal University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coxarthrosis, run by Ullevaal University Hospital at 1 site in Norway.
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 2 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: status not confirmed, as of the sponsor's last update on 24 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 Norway. 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?
Results are not available in the source record.
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?
Migration of femur- and acetabular prosthesis measured by RSA (time frame: 2008-2012). 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 24 Nov 2014.