ArthritisNCT00603395
A Prospective Clinical Study On A Total Hip Resurfacing System
A study testing ReCap Total Hip Resurfacing System in people with Arthritis and Avascular Necrosis, run by St. Anna Ziekenhuis, Geldrop, Netherlands at 1 site in Netherlands.
Trial summary
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Avascular Necrosis
- What is being tested?
- ReCap Total Hip Resurfacing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2004to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
- Osteoarthritis
- Avascular necrosis
- Traumatic arthritis
- Legg Perthes
- Rheumatoid arthritis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop
About this study
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
- Conditions
- Arthritis, Avascular Necrosis
- Being tested
- ReCap Total Hip Resurfacing System
- Medical subject headings
- Arthritis, Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReCap Total Hip Resurfacing SystemDevice
This is a hip resurfacing system.
| Study group | Role | What they receive |
|---|---|---|
| ReCap | Other | ReCap Total Hip Resurfacing System Receives: Device: ReCap Total Hip Resurfacing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Measured: 2 years postoperative
Secondary outcomes (1)
Complications
Measured: Anytime
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2012
- Study completionMay 2014
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 ArthritisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Anna Ziekenhuis, Geldrop, Netherlands
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
- Investigators
- H J Hoekstra, MD, Principal investigator, St. Anna hospital, GeldropT Sybesma, PhD, Principal investigator, St. Anna hospital, Geldrop
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00603395
- Sponsor's protocol ID
- EU-6
- Status last verified
- May 2014
- First submitted
- 23 Dec 2007
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.
PubMed 23234268
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study On A Total Hip Resurfacing System
- ClinicalTrials.gov ID
- NCT00603395
- Acronym / sponsor ID
- EU-6
- Conditions
- Arthritis, Avascular Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- St. Anna Ziekenhuis, Geldrop, NetherlandsUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 29 Jan 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 prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReCap | Other | Device: ReCap Total Hip Resurfacing SystemReCap Total Hip Resurfacing System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ReCap Total Hip Resurfacing SystemThis is a hip resurfacing system. | Device | ReCap |
Primary outcome
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time frame: 2 years postoperative
1 secondary outcome
Complications
Time frame: Anytime
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 16 May 2014.
- Derived from this study: PubMed 23234268van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.
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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.
H J Hoekstra, MD principal investigator
St. Anna hospital, Geldrop
T Sybesma, PhD principal investigator
St. Anna hospital, Geldrop
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReCap Total Hip Resurfacing System in people with Arthritis and Avascular Necrosis, run by St. Anna Ziekenhuis, Geldrop, Netherlands at 1 site in Netherlands.
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 6 inclusion and 0 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 16 May 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 Netherlands. 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?
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation (time frame: 2 years postoperative). 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 NCT00603395, 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 16 May 2014.