Rheumatoid ArthritisROCCNCT01102829
Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design
An observational study of Rheumatoid Arthritis, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 11 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2007to Apr 2010
- 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
Study population: primary care clinic
Who may be able to join
- Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
- Patient has no major deformities
- The ability to perform a lunge and step-up motion without the help of bars or a cane.
- No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)
Who cannot join
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The individual has a functional impairment of any other lower extremity joint besides the operated knee
- Patient has a flexion contracture of more than 15°
- Patient has a varus/valgus contracture of more than 15°
- Patients requiring revision arthroplasty
- The patient does not understand the Dutch or English language good enough to participate.
- The use of walking aids
- The inability to walk more than 500 meters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA
The aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).
- Conditions
- Rheumatoid Arthritis
- Keywords
- Knee Joint, Arthroplasty, Replacement, Knee
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration
Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.
Measured: 24 months post-operatively
Secondary outcomes (4)
anterior-posterior translation patterns
Fluoroscopy was used to determine the anterior-posterior translation patterns of the femoral component with respect to the tibial component.
Measured: 6 months post-operatively
Axial rotation patterns
Fluoroscopy was used to determine the axial rotation patterns of both the insert and the femoral component with respect to the tibial component
Measured: 6 months post-operatively
Muscle activity
Bipolar surface EMG data of the flexor and extensor muscles is collected.
Measured: 6 months post-operatively
Shear forces
A force plate is used to measure the ground reaction forces which can be used to calculate the shear forces.
Measured: 6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startSep 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Rob GH Nelissen, Prof, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102829
- Sponsor's protocol ID
- ROCC
- Acronym
- ROCC
- Status last verified
- Apr 2010
- First submitted
- 9 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Migration in a High Congruent Rotating Platform Total Knee Prosthesis Design. A Synchronised Motion Analysis Study With Fluoroscopy and RSA
- ClinicalTrials.gov ID
- NCT01102829
- Acronym / sponsor ID
- ROCC / ROCC
- Conditions
- Rheumatoid Arthritis
- Keywords
- Knee Joint, Arthroplasty, Replacement, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Apr 2010 (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 aim of this study is to accurately assess the relationship between knee joint kinematics and migration of the tibial component of a high congruent, rotating platform total knee prosthesis by using fluoroscopy synchronised in time and space with a force plate, an external motion registration system and Electromyography (EMG).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (5 listed)
- Patient is diagnosed with osteoarthritis and requiring primary arthroplasty
- Patient is capable of giving informed consent and expressing a willingness to comply with this study
- Patient has no major deformities
- The ability to perform a lunge and step-up motion without the help of bars or a cane.
- No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989)
Key exclusion criteria (8 listed)
- The patient is unable or unwilling to sign the Informed Consent specific to this study
- The individual has a functional impairment of any other lower extremity joint besides the operated knee
- Patient has a flexion contracture of more than 15°
- Patient has a varus/valgus contracture of more than 15°
- Patients requiring revision arthroplasty
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
Time frame: 24 months post-operatively
Roentgen stereophotogrammetric analysis is used to determine the migration of the prosthesis with respect to the bone.
4 secondary outcomes
anterior-posterior translation patterns
Time frame: 6 months post-operatively
Axial rotation patterns
Time frame: 6 months post-operatively
Muscle activity
Time frame: 6 months post-operatively
Shear forces
Time frame: 6 months post-operatively
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 13 Apr 2010.
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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.
Rob GH Nelissen, Prof, MD principal investigator
Leiden 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 Rheumatoid Arthritis, run by Leiden 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 5 inclusion and 8 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 13 Apr 2010. 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?
Migration (time frame: 24 months post-operatively). 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 13 Apr 2010.