Patellofemoral JointNCT02912429
Onlay vs. Inlay Patellofemoral Arthroplasty
A study testing Patellofemoral Arthroplasty in people with Patellofemoral Joint and Osteoarthritis, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Patellofemoral Joint, Osteoarthritis
- What is being tested?
- Patellofemoral Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2016to Jan 2020
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
Who cannot join
- systemic inflammatory arthropathy
- tibiofemoral joint degeneration IKDC grade C or worse
- severe degeneration of also the trochlea margins (inlay PFA not adequate)
- patellectomy
- previous implantation of tibiofemoral metal implants
- extension loss >5 degree
- knee flexion of less than 100°
- planned concomitant tibiofemoral procedures (eg. coronal plane osteotomies, tibiofemoral cartilage procedures, tibiofemoral ligament procedures)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Tyrol, 6020
Michael C Liebensteiner, Professor, +43 512 504 80547, michael.liebensteiner@i-med.ac.at
Michael C Liebensteiner
About this study
Official title: Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.
- Conditions
- Patellofemoral Joint, Osteoarthritis
- Being tested
- Patellofemoral Arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patellofemoral ArthroplastyDevice
| Study group | Role | What they receive |
|---|---|---|
| Inlay | Other | specific technical type of patellofemoral arthroplasty Receives: Device: Patellofemoral Arthroplasty |
| Onlay | Other | specific technical type of patellofemoral arthroplasty Receives: Device: Patellofemoral Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS knee score
Measured: 1 year
Secondary outcomes (3)
Kujala Score
Measured: 1 year
Marx Activity Scale
Measured: 1 year
HSS patella Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral JointStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Liebensteiner, Medical University Innsbruck
- Investigators
- michael liebensteiner, Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912429
- Sponsor's protocol ID
- PF-Arthroplasty 1
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
- ClinicalTrials.gov ID
- NCT02912429
- Acronym / sponsor ID
- PF-Arthroplasty 1
- Conditions
- Patellofemoral Joint, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2020 (estimated)
- First posted
- 23 Sep 2016 (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.
There is currently no sufficient evidence if there is superiority of one of the two available types (onlay type, inlay type) of patellofemoral arthroplasty. Therefore, it is the aim of this study to compare the two types in a prospective comparative setting. Patients on the waiting list for patellofemoral arthroplasty are randomized to either onlay or inlay type patellofemoral arthroplasty. The KOOS - knee score serves as the primary outcome parameter. Secondary outcome parameters are the Marx Activity Scale, the HSS patella score, the Kujala Score, radiographic loosening, progression of tibiofemoral degeneration, revision surgery and parameters of patellofemoral tracking. Inferential statistics will be performed at 1-year follow up data-sets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inlay | Other | Device: Patellofemoral Arthroplastyspecific technical type of patellofemoral arthroplasty |
| Onlay | Other | Device: Patellofemoral Arthroplastyspecific technical type of patellofemoral arthroplasty |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
Key exclusion criteria (8 listed)
- systemic inflammatory arthropathy
- tibiofemoral joint degeneration IKDC grade C or worse
- severe degeneration of also the trochlea margins (inlay PFA not adequate)
- patellectomy
- previous implantation of tibiofemoral metal implants
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 |
|---|---|---|
| Patellofemoral Arthroplasty | Device | Inlay, Onlay |
Primary outcome
KOOS knee score
Time frame: 1 year
3 secondary outcomes
Kujala Score
Time frame: 1 year
Marx Activity Scale
Time frame: 1 year
HSS patella Score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
Related trials for Patellofemoral Joint
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
Not yet recruiting
PLYOMETRIC TRAINING VERSUS CALISTHENIC TECHNIQUE FOR IMPROVING JUMP PERFORMANCE AND PATELLOFEMORAL FUNCTION IN KARATE ATHLETES
Jump Performance, Patellofemoral Joint
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
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.
michael liebensteiner principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patellofemoral Arthroplasty in people with Patellofemoral Joint and Osteoarthritis, 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 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: status not confirmed, as of the sponsor's last update on 27 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact michael C Liebensteiner (+43 512 504 ext. 80547, michael.liebensteiner@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS knee score (time frame: 1 year). 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 Sep 2016.