Onlay vs. Inlay Patellofemoral Arthroplasty
Primary Purpose
Patellofemoral Joint, Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Patellofemoral Arthroplasty
Sponsored by

About this trial
This is an interventional treatment trial for Patellofemoral Joint
Eligibility Criteria
Inclusion Criteria:
- patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
Exclusion Criteria:
- 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)
Sites / Locations
- Medical University InnsbruckRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Inlay
Onlay
Arm Description
specific technical type of patellofemoral arthroplasty
specific technical type of patellofemoral arthroplasty
Outcomes
Primary Outcome Measures
KOOS knee score
Secondary Outcome Measures
Kujala Score
Marx Activity Scale
HSS patella Score
Full Information
NCT ID
NCT02912429
First Posted
September 13, 2016
Last Updated
September 26, 2016
Sponsor
Medical University Innsbruck
1. Study Identification
Unique Protocol Identification Number
NCT02912429
Brief Title
Onlay vs. Inlay Patellofemoral Arthroplasty
Official Title
Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University Innsbruck
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Joint, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inlay
Arm Type
Other
Arm Description
specific technical type of patellofemoral arthroplasty
Arm Title
Onlay
Arm Type
Other
Arm Description
specific technical type of patellofemoral arthroplasty
Intervention Type
Device
Intervention Name(s)
Patellofemoral Arthroplasty
Primary Outcome Measure Information:
Title
KOOS knee score
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Kujala Score
Time Frame
1 year
Title
Marx Activity Scale
Time Frame
1 year
Title
HSS patella Score
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
radiolucent lines adjacent to the prosthesis
Description
radiolucent lines adjacent to the prosthesis indicate prosthesis loosening
Time Frame
20 years
Title
revision of prosthesis
Description
reoperations with ex/implantation of implants are defined as prosthetic revision
Time Frame
20 years
Title
progression of tibiofemoral osteoarthritis
Description
progression of tibiofemoral osteoarthritis is assessed in terms of IKDC grades A-D
Time Frame
20 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patellofemoral osteoarthritis, waiting list for patellofemoral arthroplasty
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
michael C Liebensteiner
Phone
+43 512 504
Ext
80547
Email
michael.liebensteiner@i-med.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
michael liebensteiner
Organizational Affiliation
Medical University Innsbruck
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael C Liebensteiner, Professor
Phone
+43 512 504 80547
Email
michael.liebensteiner@i-med.ac.at
First Name & Middle Initial & Last Name & Degree
Michael C Liebensteiner
12. IPD Sharing Statement
Learn more about this trial
Onlay vs. Inlay Patellofemoral Arthroplasty
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