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Onlay vs. Inlay Patellofemoral Arthroplasty

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ClinicalTrials.gov Identifier: NCT02912429
Recruitment Status : Recruiting
First Posted : September 23, 2016
Last Update Posted : September 27, 2016
Sponsor:
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck

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.

Condition or disease Intervention/treatment Phase
Patellofemoral Joint Osteoarthritis Device: Patellofemoral Arthroplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Onlay- vs. Inlay-Type Patellofemoral Arthroplasty: a Prospective, Comparative Study
Study Start Date : September 2016
Estimated Primary Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Inlay
specific technical type of patellofemoral arthroplasty
Device: Patellofemoral Arthroplasty
Onlay
specific technical type of patellofemoral arthroplasty
Device: Patellofemoral Arthroplasty



Primary Outcome Measures :
  1. KOOS knee score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Kujala Score [ Time Frame: 1 year ]
  2. Marx Activity Scale [ Time Frame: 1 year ]
  3. HSS patella Score [ Time Frame: 1 year ]

Other Outcome Measures:
  1. radiolucent lines adjacent to the prosthesis [ Time Frame: 20 years ]
    radiolucent lines adjacent to the prosthesis indicate prosthesis loosening

  2. revision of prosthesis [ Time Frame: 20 years ]
    reoperations with ex/implantation of implants are defined as prosthetic revision

  3. progression of tibiofemoral osteoarthritis [ Time Frame: 20 years ]
    progression of tibiofemoral osteoarthritis is assessed in terms of IKDC grades A-D



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912429


Contacts
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Contact: michael C Liebensteiner +43 512 504 ext 80547 michael.liebensteiner@i-med.ac.at

Locations
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Austria
Medical University Innsbruck Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Michael C Liebensteiner, Professor    +43 512 504 80547    michael.liebensteiner@i-med.ac.at   
Principal Investigator: Michael C Liebensteiner         
Sponsors and Collaborators
Medical University Innsbruck
Investigators
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Principal Investigator: michael liebensteiner Medical University Innsbruck

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Responsible Party: Michael Liebensteiner, Principal Investigator and Coordinating Investigator, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT02912429     History of Changes
Other Study ID Numbers: PF-Arthroplasty 1
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases