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Patellofemoral Pain After Unicondylar Knee Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michael Liebensteiner, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT01407042
First received: July 26, 2011
Last updated: July 16, 2016
Last verified: July 2016

July 26, 2011
July 16, 2016
September 2011
December 2014   (final data collection date for primary outcome measure)
  • Size of anterior femoral notch [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    Required cartilage / bone removal adjacent to the femoral implant
  • Kujala Score changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • KOOS questionnaire changes [ Time Frame: -1 days, 3 months, 6 months, 1 year ] [ Designated as safety issue: No ]
  • Radionuclide tracer uptake at the surgically created notch [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01407042 on ClinicalTrials.gov Archive Site
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Patellofemoral Pain After Unicondylar Knee Arthroplasty
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
consecutive patients scheduled for unicondylar knee arthroplasty at the Dept. for orthopaedic surgery of our medical university
Mobile-bearing Unicondylar Knee Arthroplasty
Procedure: mobile-bearing unicondylar knee arthroplasty
mobile-bearing unicondylar knee arthroplasty
mb-UKA
Patients with unicondylar osteoarthritis of the knee
Intervention: Procedure: mobile-bearing unicondylar knee arthroplasty
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
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December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01407042
PFJ-UKA-1
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Michael Liebensteiner, Medical University Innsbruck
Medical University Innsbruck
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Medical University Innsbruck
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP