Mobile-bearing Unicondylar Knee ArthroplastyNCT01407042
Patellofemoral Pain After Unicondylar Knee Arthroplasty
An observational study of Mobile-bearing Unicondylar Knee Arthroplasty, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mobile-bearing Unicondylar Knee Arthroplasty
- What is being tested?
- mobile-bearing unicondylar knee arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2011to Dec 2014
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university
Who may be able to join
- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment
Who cannot join
- failed upper tibial osteotomy
- insufficiency of the collateral or anterior cruciate ligaments
- a fixed varus or valgus deformity (not passively correctable) above 15°
- a flexion deformity greater than 15°
- rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.
We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.
Read more
In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala \& KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.
The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.
- Being tested
- mobile-bearing unicondylar knee arthroplasty
- Keywords
- unicondylar knee arthroplasty, mobile-bearing, patellofemoral pain
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-bearing unicondylar knee arthroplastyProcedure or surgery
mobile-bearing unicondylar knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| mb-UKA | Patients with unicondylar osteoarthritis of the knee Receives: Procedure: mobile-bearing unicondylar knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of anterior femoral notch
Required cartilage / bone removal adjacent to the femoral implant
Measured: day 0
Kujala Score changes
Measured: -1 days, 3 months, 6 months, 1 year
KOOS questionnaire changes
Measured: -1 days, 3 months, 6 months, 1 year
Radionuclide tracer uptake at the surgically created notch
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 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 Mobile-bearing Unicondylar Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Liebensteiner, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407042
- Sponsor's protocol ID
- PFJ-UKA-1
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2011
- Last updated
- 19 Jul 2016
- Results posted
- No
Publications
Dammerer D, Liebensteiner M, Rochau H, Uprimny C, Smekal V, Rosenberger R, Servien E. Influence of the anterior notch in mobile-bearing UKA on patellofemoral radiotracer uptake and clinical outcome. BMC Musculoskelet Disord. 2017 Dec 16;18(1):532. doi: 10.1186/s12891-017-1885-6.
PubMed 29246134
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patellofemoral Pain After Unicondylar Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01407042
- Acronym / sponsor ID
- PFJ-UKA-1
- Keywords
- unicondylar knee arthroplasty, mobile-bearing, patellofemoral pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2014 (actual)
- First posted
- 1 Aug 2011 (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.
Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.
We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.
In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala \& KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.
The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mb-UKA | – | Procedure: mobile-bearing unicondylar knee arthroplastyPatients with unicondylar osteoarthritis of the knee |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university
Key inclusion criteria (1 listed)
- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment
Key exclusion criteria (5 listed)
- failed upper tibial osteotomy
- insufficiency of the collateral or anterior cruciate ligaments
- a fixed varus or valgus deformity (not passively correctable) above 15°
- a flexion deformity greater than 15°
- rheumatoid arthritis
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 |
|---|---|---|
| mobile-bearing unicondylar knee arthroplastymobile-bearing unicondylar knee arthroplasty | Procedure or surgery | mb-UKA |
Primary outcome
Size of anterior femoral notch
Time frame: day 0
Required cartilage / bone removal adjacent to the femoral implant
Kujala Score changes
Time frame: -1 days, 3 months, 6 months, 1 year
KOOS questionnaire changes
Time frame: -1 days, 3 months, 6 months, 1 year
Radionuclide tracer uptake at the surgically created notch
Time frame: 6 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 19 Jul 2016.
- Derived from this study: PubMed 29246134Dammerer D, Liebensteiner M, Rochau H, Uprimny C, Smekal V, Rosenberger R, Servien E. Influence of the anterior notch in mobile-bearing UKA on patellofemoral radiotracer uptake and clinical outcome. BMC Musculoskelet Disord. 2017 Dec 16;18(1):532. doi: 10.1186/s12891-017-1885-6.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mobile-bearing Unicondylar Knee Arthroplasty, run by Medical University Innsbruck at 1 site in Austria.
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 5 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 19 Jul 2016. 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 Austria. 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?
Size of anterior femoral notch (time frame: day 0). The study lists 4 primary outcomes in all. 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 NCT01407042, 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 19 Jul 2016.