Osteoarthritis, KneeNCT00163228
Functional Evaluation of the Total Knee Prostheses:Rising From a Chair
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2001to May 2007
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- unilateral TKA
Who cannot join
- TKA bilateral
- recent THP
- movement disorders like Parkinson's disease, insults, that disturb equilibrium and movements
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ORL, Radboud University Nijmegen Medical Centre
Nijmegen, 6500HB
About this study
Official title: Functional Evaluation of Total Knee Arthroplasties,Protocol for Rising From a Chair.
In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. At last, the TKA group will be compared to a THP group.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- C05.550.114.606.500, C05.550.114.606.508
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startJan 2001
- Study completionMay 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Investigators
- Nico Verdonschot, Phd, Study chair, ORL, Radboud University Nijmegen Medical CenterMaarten de Waal Malefijt, MD, Study chair, ORL, Radboud University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163228
- Sponsor's protocol ID
- FWB Stratec 96856
- Other IDs
- FBW Stratec 96856
- Status last verified
- Oct 2008
- First submitted
- 9 Sep 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
Publications
Boonstra MC, Schreurs BW, Verdonschot N. The sit-to-stand movement: differences in performance between patients after primary total hip arthroplasty and revision total hip arthroplasty with acetabular bone impaction grafting. Phys Ther. 2011 Apr;91(4):547-54. doi: 10.2522/ptj.20090376. Epub 2011 Feb 24.
PubMed 21350030Boonstra MC, Schwering PJ, De Waal Malefijt MC, Verdonschot N. Sit-to-stand movement as a performance-based measure for patients with total knee arthroplasty. Phys Ther. 2010 Feb;90(2):149-56. doi: 10.2522/ptj.20090119. Epub 2009 Dec 10.
PubMed 20007664
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Evaluation of Total Knee Arthroplasties,Protocol for Rising From a Chair.
- ClinicalTrials.gov ID
- NCT00163228
- Acronym / sponsor ID
- FWB Stratec 96856
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- C05.550.114.606.500, C05.550.114.606.508
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Jan 2001
- Study completion
- May 2007 (estimated)
- First posted
- 13 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.
In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. At last, the TKA group will be compared to a THP group.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral TKA
Key exclusion criteria (3 listed)
- TKA bilateral
- recent THP
- movement disorders like Parkinson's disease, insults, that disturb equilibrium and movements
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
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2008.
- Derived from this study: PubMed 21350030Boonstra MC, Schreurs BW, Verdonschot N. The sit-to-stand movement: differences in performance between patients after primary total hip arthroplasty and revision total hip arthroplasty with acetabular bone impaction grafting. Phys Ther. 2011 Apr;91(4):547-54. doi: 10.2522/ptj.20090376. Epub 2011 Feb 24.
- Derived from this study: PubMed 20007664Boonstra MC, Schwering PJ, De Waal Malefijt MC, Verdonschot N. Sit-to-stand movement as a performance-based measure for patients with total knee arthroplasty. Phys Ther. 2010 Feb;90(2):149-56. doi: 10.2522/ptj.20090119. Epub 2009 Dec 10.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Nico Verdonschot, Phd study chair
ORL, Radboud University Nijmegen Medical Center
Maarten de Waal Malefijt, MD study chair
ORL, Radboud University Medical Centre
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 and Osteoarthritis, Hip, 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 3 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: withdrawn, as of the sponsor's last update on 16 Oct 2008. 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 was withdrawn before enrolling participants, so there are no results.
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 NCT00163228, which also lists 2 linked publications.
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 Oct 2008.