Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty
Key facts
- Who runs it
- University Hospital, Gentofte, Copenhagen
- Where
- Denmark11 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 350 people enrolled
- Started
- 17 Aug 2017
- Expected to end
- 16 Oct 2041
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Unicondylar Knee Arthroplasty
- Total Knee Arthroplasty
- Record updated
- 23 October 2023
Who can take part
- Age
- 18 years to 110 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- Anteromedial OA of the knee as diagnosed on posteroanterior and lateral projections of the knee, and symptoms of sufficient severity to justify arthroplasty. Each patient can only participate with one knee, but may be eligible with both knees. Eligibility is independent of possible previous procedures to index or contralateral knee, and to age, sex, occupation and etiology of the anteromedial OA
- Bone og Bone medially on pre-operative radiographs
Who cannot take part
- knee instability caused by either cruciate or collateral ligament insufficiency,
- rheumatoid or other inflammatory arthropathy, 3) lateral patellar subluxation on skyline views with articular cartilage thinning of the patellofemoral joint. Specific exclusion criteria for study participation are: 1) age below 18 years of age, 2) limited possibilities of understanding and assessing study information (e.g. severe psychiatric or mental conditions and non-Danish speaking), 3) occupational or personal relation to surgeons responsible for treatment (e.g. employment in participating orthopedic departments)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
In treatment of isolated medial unicondylar osteoarthritis of the knee (MU-OA), it is possible to choose between surgery with a unicondylar knee arthroplasty (UKA), or a total knee arthroplasty (TKA).
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Supporters of TKA suggest that this treatment gives a more predictable and better result, whereas supporters of UKA suggest that it is unnecessary to remove decent and functional cartilage in other compartments, and also that generally the UKA gives better results under certain circumstances. If the UKA is worn out or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be much more problematic.
Also, it is of great interest to measure the direct costs of these treatments. Both general hospital costs, but also costs in societal in terms of sick-days, pain-killer expenditure, and physiotherapy.
The aim of this study is to compare the results, in terms of 1) patient-reported outcomes, 2) clinical results including prosthetic survival and 3) costs.
The 2 groups in the trial
- Unicondylar Knee ArhtroplastyTreatment being tested
Operation with insertion of a knee arthroplasty using a unicompartmental device (Oxford phase 3, mobile bearing, uncemented)
Treatment: Unicondylar Knee Arthroplasty
- Total Knee ArthroplastyExisting treatment, for comparison
Operation with insertion of a knee arthroplasty using a total condylar device (PCR, nexgen with resurfacing, cemented)
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Clinical Trial of Medial Unicompartmentel Versus Total Arthroplasty for Medial Tibio-femoral OA.
- Record updated
- 23 October 2023