Onlay vs. Inlay Patellofemoral Arthroplasty

Osteoarthritis Clinical Trial

Official title:

Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02912429
• Other study ID #: PF-Arthroplasty 1
• 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. 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

• Osteoarthritis
• Patellofemoral Joint

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