Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty (UKAvsTKA)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03396640|
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : August 28, 2018
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).
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Unicondylar Knee Arthroplasty Procedure: Total Knee Arthroplasty||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double Blinded, randomized controlled trial.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Stratified, permuted block randomization with a 1:1 allocation ratio. Block sizes will be 4, 6, 8 and 10. Stratification will be two-dimensional, where surgeon is one dimension and patient sex the other. The randomization will be done immediately preceding surgery. Randomization is blinded to everyone (patient, staff, GP, physiotherapists etc.) except theatre staff, for the first year following surgery.|
|Official Title:||Randomized Clinical Trial of Medial Unicompartmentel Versus Total Arthroplasty for Medial Tibio-femoral OA.|
|Actual Study Start Date :||August 17, 2017|
|Estimated Primary Completion Date :||May 16, 2019|
|Estimated Study Completion Date :||October 16, 2039|
Experimental: Unicondylar Knee Arhtroplasty
Operation with insertion of a knee arthroplasty using a unicompartmental device (Oxford phase 3, mobile bearing, uncemented)
Procedure: Unicondylar Knee Arthroplasty
Incision will be midline incision, as with a TKA, for maximum security of blinding.
Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.
Active Comparator: Total Knee Arthroplasty
Operation with insertion of a knee arthroplasty using a total condylar device (PCR, nexgen with resurfacing, cemented)
Procedure: Total Knee Arthroplasty
Incision will be midline incision, as standard. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.
- Oxford Knee Score [ Time Frame: 20 years ]Questionnaire. Oxford Knee Score Scale range 0 (severe arthritis) - 48 (satisfactory joint function)
- cost utility analysis [ Time Frame: 20 years ]cost per QALY
- gait analysis [ Time Frame: 1 year ]Telemetric assesment of gait parametres
- Implant survival [ Time Frame: 20 years ]analysis of implant survival
- clinical outcome [ Time Frame: 20 years ]Knee range of movement
- Knee Osteoarthritis Outcome Score [ Time Frame: 20 years ]questionnaire. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Scale of score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale (scoring instructions are available in a separate document: KOOS Scoring). The five individual KOOS subscale scores are then given as secondary outcomes to enable clinical interpretation. The results of the 5 subscales can be plotted as an outcome profile (order of subscales from left to right: Pain, Symptoms, ADL, Sport/Rec and QOL), preferably in a graph with scores from 0-100 on the y-axis and the five subscales on the x-axis.
- Forgotten Joint Score [ Time Frame: 20 years ]questionnaire. When calculating the total score for the FJS, all responses are summed (never, 0 points; almost never, 1 point; seldom, 2 points; sometimes, 3 points; mostly, 4 points) and then divided by the number of completed items (questions met with "not relevant for me" were treated as having a missing value and were not included in completed items). This mean value is subsequently multiplied by 25 to obtain a total score range of 0 to 100. Finally, the score is subtracted from 100 to change the direction of the final score in such a way that high scores indicate a high degree of "forgetting" the artificial joint—i.e. a low degree of awareness. If more than 4 responses are "not relevant for me" or missing, the total score should be discarded (Behrend et al. 2012).
- Short Form (36) Health Survey [ Time Frame: 20 years ]
Questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate.
The eight sections are:
vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health
- EQ5D [ Time Frame: 20 years ]
Questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
- Clinical outcome [ Time Frame: 20 years ]knee effusion
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): NCT03396640
|Contact: Anders Odgaard, Consultantemail@example.com|
|Contact: Jacob F Mortensen, MDfirstname.lastname@example.org|
|Copenhagen, Gentofte, Denmark, 2900|
|Contact: Jacob F Mortensen, Doctor, PhD 26814442 email@example.com|
|Aalborg Universitetshospital, Farsø||Recruiting|
|Farsø, Denmark, 9640|
|Contact: Andreas Kappel, Consultant +4520604629 firstname.lastname@example.org|
|Frederikshavn, Denmark, 9900|
|Contact: Svend E Østgaard, Consultant +4526186604 email@example.com|
|Næstved Sygehus||Not yet recruiting|
|Næstved, Denmark, 4700|
|Contact: Henrik M Schrøder, Consultant +450567163 firstname.lastname@example.org|
|Vejle, Denmark, 7100|
|Contact: Lasse E Rasmussen, Consultant +4522384840 Lasse.email@example.com|
|Århus, Denmark, 8000|
|Contact: Frank Madsen, Consultant +4522127214 firstname.lastname@example.org|
|Principal Investigator:||Anders Odgaard, Consultant||Gentofte Hospital|