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Patellofemoral Pain After Unicondylar Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407042
First Posted: August 1, 2011
Last Update Posted: July 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck
  Purpose

Unicondylar knee arthroplasty (UKA) is a proven procedure in patients suffering from unicompartmental knee osteoarthritis. Two different types of UKA design are available - both with different pros and cons. The so-called 'mobile-bearing UKA' requires the removal of an additional amount of cartilage and bone close to the implantat. It is unclear whether this is of clinical relevance.

We speculate that the amount of cartilage/bone removal is related to the clinical outcome of the UKA-surgery.

In patients receiving a mobile-bearing UKA that amount of cartilage/bone removal is measured during the surgery. The clinical success of the procedure will be determined with certain knee questionnaires (Kujala & KOOS)preoperatively, 3 months postoperatively, 6 months postoperatively and 1 year postoperatively. Additionally, the so-called bone-remodelling around that area of resected cartilage and bone will be measured (SPECT-CT) postoperatively.

The three variables (removed amount of cartilage/bone; clinical success with regard to the questionnaires; bone remodelling) are then analyzed with statistical methods to find out potential assoziations among them.


Condition Intervention
Mobile-bearing Unicondylar Knee Arthroplasty Procedure: mobile-bearing unicondylar knee arthroplasty

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Michael Liebensteiner, Medical University Innsbruck:

Primary Outcome Measures:
  • Size of anterior femoral notch [ Time Frame: day 0 ]
    Required cartilage / bone removal adjacent to the femoral implant

  • Kujala Score changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ]
  • KOOS questionnaire changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ]
  • Radionuclide tracer uptake at the surgically created notch [ Time Frame: 6 months ]

Enrollment: 24
Study Start Date: September 2011
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
mb-UKA
Patients with unicondylar osteoarthritis of the knee
Procedure: mobile-bearing unicondylar knee arthroplasty
mobile-bearing unicondylar knee arthroplasty

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university
Criteria

Inclusion Criteria:

- osteoarthritis or osteonecrosis in the medial or lateral tibiofemoral compartment

Exclusion Criteria:

  • failed upper tibial osteotomy
  • insufficiency of the collateral or anterior cruciate ligaments
  • a fixed varus or valgus deformity (not passively correctable) above 15°
  • a flexion deformity greater than 15°
  • rheumatoid arthritis
  Contacts and Locations
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): NCT01407042


Locations
Austria
Innsbruck Medical University
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
  More Information

Responsible Party: Michael Liebensteiner, MD, PhD, Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT01407042     History of Changes
Other Study ID Numbers: PFJ-UKA-1
First Submitted: July 26, 2011
First Posted: August 1, 2011
Last Update Posted: July 19, 2016
Last Verified: July 2016

Keywords provided by Michael Liebensteiner, Medical University Innsbruck:
unicondylar knee arthroplasty
mobile-bearing
patellofemoral pain