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OpenTrials
Completed

NCT Number: NCT01407042

Patellofemoral Pain After Unicondylar Knee Arthroplasty

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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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Innsbruck Medical University

Innsbruck, 6020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mobile-bearing unicondylar knee arthroplasty

Procedure

mobile-bearing unicondylar knee arthroplasty

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
First posted
Aug 1, 2011
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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