OsteoarthritisNCT01150929
Rehabilitation After Total Knee Arthroplasty (TKA) - PFC Rotating Versus Fixed Bearing
A study testing P.F.C. Sigma knee arthroplasty in people with Osteoarthritis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs. The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- P.F.C. Sigma knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2007to 31 Dec 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.
Who cannot join
- Neurologic disease with impact on gait.
- Orthopaedic disease ipsilateral hip joint.
- Patients outside the age limits.
- No informed consent signed.
- Patients suffering from dementia.
- Patients primarily included, but who perioperatively has their posterior cruciate ligament injured or sacrificed.
- Patients who later develop deep venous thrombosis or infection in the operated knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene
The purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.
The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.
- Conditions
- Osteoarthritis
- Being tested
- P.F.C. Sigma knee arthroplasty
- Keywords
- Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P.F.C. Sigma knee arthroplastyDevice
Also called PFC Sigma from DePuy International implants used.
Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
| Study group | Role | What they receive |
|---|---|---|
| Fixed bearing | Active comparator | One of the 2 used implants. Receives: Device: P.F.C. Sigma knee arthroplasty |
| Rotating platform | Active comparator | One of the 2 used implants. Receives: Device: P.F.C. Sigma knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radio Stereometric Analysis
Patients are analysed with stereo x-rays to asses implant micromigration.
Measured: 24 months
Secondary outcomes (2)
Gait analysis
Motion analysis is performed prior to surgery and after 6 and 12 months follow-up. Patients serve as their own control.
Measured: 12 months
DXA
Dual Energy X-ray Absorptiometry (DXA) is used to asses bone mineral density (BMD) around the implant.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study start1 Mar 2007
- Primary completion31 Aug 2012
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Silkeborg, Gigtforeningen, Protesekompagniet
- Responsible party
- Sponsor
- Investigators
- Kjeld Soballe, DMsc, Study chair, Aarhus Sygehus THG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150929
- Sponsor's protocol ID
- 20050031
- Status last verified
- Dec 2022
- First submitted
- 14 Jun 2010
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation After Total Knee Arthroplasty - Rotating Platform Versus Fixed Bearing Polyethylene
- ClinicalTrials.gov ID
- NCT01150929
- Acronym / sponsor ID
- 20050031
- Conditions
- Osteoarthritis
- Keywords
- Knee arthroplasty, RSA, DXA, Gait analysis, Motion analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Silkeborg, Gigtforeningen, Protesekompagniet
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 31 Aug 2012 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 25 Jun 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 purpose of this study is to determine whether patient rehabilitation is equal for patients operated with two different knee implant designs.
The patients are randomized to treatment with either a simple hinge design implant (fixed bearing) or an implant with a mobile bearing polyethylene. This design difference might in principle enable the patients in the latter group to rehabilitate towards a more normal gait pattern.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed bearing | Active comparator | Device: P.F.C. Sigma knee arthroplastyOne of the 2 used implants. |
| Rotating platform | Active comparator | Device: P.F.C. Sigma knee arthroplastyOne of the 2 used implants. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at Silkeborg Regional Hospital, Orthopedic Dept. referred to total knee arthroplasty.
Key exclusion criteria (7 listed)
- Neurologic disease with impact on gait.
- Orthopaedic disease ipsilateral hip joint.
- Patients outside the age limits.
- No informed consent signed.
- Patients suffering from dementia.
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 |
|---|---|---|
| P.F.C. Sigma knee arthroplastyAlso: PFC Sigma from DePuy International implants used.Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene | Device | Fixed bearing, Rotating platform |
Primary outcome
Radio Stereometric Analysis
Time frame: 24 months
Patients are analysed with stereo x-rays to asses implant micromigration.
2 secondary outcomes
Gait analysis
Time frame: 12 months
DXA
Time frame: 24 months
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 27 Dec 2022.
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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.
Kjeld Soballe, DMsc study chair
Aarhus Sygehus THG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P.F.C. Sigma knee arthroplasty in people with Osteoarthritis, run by University of Aarhus 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 1 inclusion and 7 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 27 Dec 2022. 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?
Radio Stereometric Analysis (time frame: 24 months). 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 27 Dec 2022.