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Trial record 1 of 1 for:    NCT01407042
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Patellofemoral Pain After Unicondylar Knee Arthroplasty

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. Identifier: NCT01407042
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : July 19, 2016
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck

Brief Summary:

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 or disease Intervention/treatment
Mobile-bearing Unicondylar Knee Arthroplasty Procedure: mobile-bearing unicondylar knee arthroplasty

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : September 2011
Actual Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
Patients with unicondylar osteoarthritis of the knee
Procedure: mobile-bearing unicondylar knee arthroplasty
mobile-bearing unicondylar knee arthroplasty

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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

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

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 identifier (NCT number): NCT01407042

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Innsbruck Medical University
Innsbruck, Austria, 6020
Sponsors and Collaborators
Medical University Innsbruck
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Michael Liebensteiner, MD, PhD, Medical University Innsbruck Identifier: NCT01407042    
Other Study ID Numbers: PFJ-UKA-1
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Keywords provided by Michael Liebensteiner, Medical University Innsbruck:
unicondylar knee arthroplasty
patellofemoral pain