Onlay vs. Inlay Patellofemoral Arthroplasty
Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
1 other identifier
interventional
110
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
September 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedSeptember 27, 2016
September 1, 2016
3.3 years
September 13, 2016
September 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
KOOS knee score
1 year
Secondary Outcomes (3)
Kujala Score
1 year
Marx Activity Scale
1 year
HSS patella Score
1 year
Other Outcomes (3)
radiolucent lines adjacent to the prosthesis
20 years
revision of prosthesis
20 years
progression of tibiofemoral osteoarthritis
20 years
Study Arms (2)
Inlay
OTHERspecific technical type of patellofemoral arthroplasty
Onlay
OTHERspecific technical type of patellofemoral arthroplasty
Interventions
Eligibility Criteria
You may qualify if:
- patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
michael liebensteiner
Medical University Innsbruck
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator and Coordinating Investigator
Study Record Dates
First Submitted
September 13, 2016
First Posted
September 23, 2016
Study Start
September 1, 2016
Primary Completion
January 1, 2020
Last Updated
September 27, 2016
Record last verified: 2016-09