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Medial Unicondylar Knee Arthroplasty vs Total Knee Arthroplasty (UKAvsTKA)

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ClinicalTrials.gov Identifier: NCT03396640
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Naestved Hospital
Vejle Hospital
Aarhus University Hospital
Aalborg Universitetshospital
Information provided by (Responsible Party):
Jacob Fyhring Mortensen, University Hospital, Gentofte, Copenhagen

Brief Summary:

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
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Oxford Knee Score [ Time Frame: 20 years ]
    Questionnaire. Oxford Knee Score Scale range 0 (severe arthritis) - 48 (satisfactory joint function)


Secondary Outcome Measures :
  1. cost utility analysis [ Time Frame: 20 years ]
    cost per QALY

  2. gait analysis [ Time Frame: 1 year ]
    Telemetric assesment of gait parametres

  3. Implant survival [ Time Frame: 20 years ]
    analysis of implant survival

  4. clinical outcome [ Time Frame: 20 years ]
    Knee range of movement

  5. 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.

  6. 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).

  7. 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


  8. 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.


  9. Clinical outcome [ Time Frame: 20 years ]
    knee effusion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  1. knee instability caused by either cruciate or collateral ligament insufficiency,
  2. 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).

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 ClinicalTrials.gov identifier (NCT number): NCT03396640


Contacts
Contact: Anders Odgaard, Consultant +4527478245 ao@knee.dk
Contact: Jacob F Mortensen, MD +4526814442 mortensen.jacob.f@gmail.com

Locations
Denmark
Gentofe Hospital Recruiting
Copenhagen, Gentofte, Denmark, 2900
Contact: Jacob F Mortensen, Doctor, PhD    26814442    mortensen.jacob.f@gmail.com   
Aalborg Universitetshospital, Farsø Not yet recruiting
Farsø, Denmark, 9640
Contact: Andreas Kappel, Consultant    +4520604629    andreas.kappel@rn.dk   
Frederikshavn Sygehus Not yet recruiting
Frederikshavn, Denmark, 9900
Contact: Svend E Østgaard, Consultant    +4526186604    sveo@rn.dk   
Næstved Sygehus Not yet recruiting
Næstved, Denmark, 4700
Contact: Henrik M Schrøder, Consultant    +450567163    hemsc@regionsjaelland.dk   
Vejle Sygehus Not yet recruiting
Vejle, Denmark, 7100
Contact: Lasse E Rasmussen, Consultant    +4522384840    Lasse.enkeboelle.rasmussen@rsyd.dk   
Aarhus Universitetshospital Recruiting
Århus, Denmark, 8000
Contact: Frank Madsen, Consultant    +4522127214    frank.madsen@aarhus.rm.dk   
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Naestved Hospital
Vejle Hospital
Aarhus University Hospital
Aalborg Universitetshospital
Investigators
Principal Investigator: Anders Odgaard, Consultant Gentofte Hospital

Responsible Party: Jacob Fyhring Mortensen, Doctor, PhD-student, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03396640     History of Changes
Other Study ID Numbers: H-16037372
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This will be decided at a meeting with fellow surgeons once inclusion has started.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacob Fyhring Mortensen, University Hospital, Gentofte, Copenhagen:
anteromedial

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases