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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02912429
Other study ID # PF-Arthroplasty 1
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 2016
Last updated September 26, 2016
Start date September 2016

Study information

Verified date September 2016
Source Medical University Innsbruck
Contact michael C Liebensteiner
Phone +43 512 504
Email michael.liebensteiner@i-med.ac.at
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Patellofemoral Arthroplasty


Locations

Country Name City State
Austria Medical University Innsbruck Innsbruck Tyrol

Sponsors (1)

Lead Sponsor Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other radiolucent lines adjacent to the prosthesis radiolucent lines adjacent to the prosthesis indicate prosthesis loosening 20 years No
Other revision of prosthesis reoperations with ex/implantation of implants are defined as prosthetic revision 20 years No
Other progression of tibiofemoral osteoarthritis progression of tibiofemoral osteoarthritis is assessed in terms of IKDC grades A-D 20 years No
Primary KOOS knee score 1 year No
Secondary Kujala Score 1 year No
Secondary Marx Activity Scale 1 year No
Secondary HSS patella Score 1 year No
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