Patients Suitable for THANCT00249054
Prospective Clinical Evaluation of ASR and ReCap Resurfacing Arthroplasty
A study testing ASR hip prosthesis and ReCap hip prosthesis in people with Patients Suitable for THA, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by: Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Suitable for THA
- What is being tested?
- ASR hip prosthesis and ReCap hip prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2005to Nov 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II,DEXA-scanning:
- lower limit for a 55 years old women,
- MRI normal
- vitality in caput
- willing to return for follow-up evaluations.
Who cannot join
- collum femoris < 2 cm
- large cysts in caput (> 1 cm)
- mismatch between caput and acetabulum
- caput necrosis
- treatment with medicine which affects bone metabolism
- impaired kidney function.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Frederiksberg University Hospital
Frederiksberg, Copenhagen, 2000
About this study
Official title: Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
This evaluation is being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:
Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.
Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI
- Conditions
- Patients Suitable for THA
- Being tested
- ASR hip prosthesis, ReCap hip prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASR hip prosthesisDevice
Also called DuPuy ASR hip prosthesis
Implantation of resurfacing prosthesis
ReCap hip prosthesisDevice
Also called Biomet ReCap hip prosthesis
Implantation of resurfacing prosthesis
| Study group | Role | What they receive |
|---|---|---|
| ASR hip prosthesis | Active comparator | DuPuy ASR hip prosthesis Receives: Device: ASR hip prosthesis; Device: ReCap hip prosthesis |
| ReCap hip prosthesis | Active comparator | Biomet ReCap hip prosthesis Receives: Device: ReCap hip prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
follow with intervals of 1 to 3 years for determination of function and prosthesis survival
Measured: 10 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Suitable for THAStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arne Borgwardt, Frederiksberg University Hospital
- Investigators
- arne borgwardt, M.D., Study director, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249054
- Sponsor's protocol ID
- KF11279577
- Status last verified
- Mar 2017
- First submitted
- 3 Nov 2005
- Last updated
- 24 Mar 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
- ClinicalTrials.gov ID
- NCT00249054
- Acronym / sponsor ID
- KF11279577
- Conditions
- Patients Suitable for THA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2012 (actual)
- First posted
- 7 Nov 2005 (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 being conducted to evaluate the performance of the ASR arthroplasty. The performance of the devices will be assessed by:
Clinical parameters: pain, function, satisfaction and complications. Blood samples: Analyse of metal ions, lymphocyte migration, lymphocyte proliferation assay and cytokines.
Biopsies: Metal ions, cytokines and histology. Biomechanics: Strength, gait analysis, range of motion. Scanning: DEXA and MRI
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASR hip prosthesis | Active comparator | Device: ASR hip prosthesis, Device: ReCap hip prosthesisDuPuy ASR hip prosthesis |
| ReCap hip prosthesis | Active comparator | Device: ReCap hip prosthesisBiomet ReCap hip prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- lower limit for a 55 years old women,
- MRI normal
- vitality in caput
- willing to return for follow-up evaluations.
Key exclusion criteria (6 listed)
- collum femoris < 2 cm
- large cysts in caput (> 1 cm)
- mismatch between caput and acetabulum
- caput necrosis
- treatment with medicine which affects bone metabolism
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 |
|---|---|---|
| ASR hip prosthesisAlso: DuPuy ASR hip prosthesisImplantation of resurfacing prosthesis | Device | ASR hip prosthesis |
| ReCap hip prosthesisAlso: Biomet ReCap hip prosthesisImplantation of resurfacing prosthesis | Device | ASR hip prosthesis, ReCap hip prosthesis |
Primary outcome
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up.
Time frame: 10 year follow up
follow with intervals of 1 to 3 years for determination of function and prosthesis survival
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 24 Mar 2017.
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.
arne borgwardt, M.D. study director
Frederiksberg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASR hip prosthesis and ReCap hip prosthesis in people with Patients Suitable for THA, run by Frederiksberg University Hospital at 1 site in Denmark.
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 5 inclusion and 6 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 24 Mar 2017. 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 Denmark. 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?
Clinical Performance of the ASR and ReCap Resurfacing Implants-7Years Follow-Up. (time frame: 10 year follow up). 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 Mar 2017.