Osteoarthritis, KneeNCT00228137
Randomised Controlled Trial PFC Versus CKS Total Knee Prostheses
An observational study of Osteoarthritis, Knee, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2002to Nov 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.
Who cannot join
- patient suffering from juvenile rheumatic disease
- patient suffering hemophilia
- patient on the waiting list for posterior stabilized TKA or hinge joint.
- patient who suffers from a lesion of the ligaments due to surgery
- patient who is legally not capable to make decisions
- patient who suffer from cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Double-Blind Study to Assess the Functional Differences Between the PFC and CKS Knee Prostheses
The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.
- Conditions
- Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startNov 2002
- Study completionNov 2012 (estimated)
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 Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Maarten MC de Waal Malefijt, MD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228137
- Sponsor's protocol ID
- HJM25577
- Other IDs
- FBW STRATEC 96856
- Status last verified
- Aug 2007
- First submitted
- 13 Sep 2005
- Last updated
- 9 Aug 2007
- Results posted
- No
Publications
Meijerink HJ, Verdonschot N, van Loon CJ, Hannink G, de Waalmalefijt MC. Similar TKA designs with differences in clinical outcome: a randomized, controlled trial of 77 knees with a mean follow-up of 6 years. Acta Orthop. 2011 Dec;82(6):685-91. doi: 10.3109/17453674.2011.636677. Epub 2011 Nov 9.
PubMed 22066559
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double-Blind Study to Assess the Functional Differences Between the PFC and CKS Knee Prostheses
- ClinicalTrials.gov ID
- NCT00228137
- Acronym / sponsor ID
- HJM25577
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Nov 2012 (estimated)
- First posted
- 28 Sep 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.
The purpose of this study is to compare the functional outcome of two different total knee prostheses in a prospective randomised study.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients on the waiting list for a TKA due to an invalidating gonarthrose as a result of osteo-arthrosis or secondary to a rheumatic disease or a trauma.
Key exclusion criteria (6 listed)
- patient suffering from juvenile rheumatic disease
- patient suffering hemophilia
- patient on the waiting list for posterior stabilized TKA or hinge joint.
- patient who suffers from a lesion of the ligaments due to surgery
- patient who is legally not capable to make decisions
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2007.
- Derived from this study: PubMed 22066559Meijerink HJ, Verdonschot N, van Loon CJ, Hannink G, de Waalmalefijt MC. Similar TKA designs with differences in clinical outcome: a randomized, controlled trial of 77 knees with a mean follow-up of 6 years. Acta Orthop. 2011 Dec;82(6):685-91. doi: 10.3109/17453674.2011.636677. Epub 2011 Nov 9.
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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.
Maarten MC de Waal Malefijt, MD study chair
Radboud University Medical Center
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 Osteoarthritis, Knee, run by Radboud University Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2007. 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?
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00228137, 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 9 Aug 2007.