NCT03396640

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
188mo left

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Aug 2017Oct 2041

Study Start

First participant enrolled

August 17, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
23.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2041

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2041

Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

24.2 years

First QC Date

September 19, 2017

Last Update Submit

October 18, 2023

Conditions

Osteoarthritis, Knee

Keywords

anteromedial

Outcome Measures

Primary Outcomes (1)

  • Oxford Knee Score

    Questionnaire. Oxford Knee Score Scale range 0 (severe arthritis) - 48 (satisfactory joint function)

    20 years

Secondary Outcomes (9)

  • cost utility analysis

    20 years

  • gait analysis

    1 year

  • Implant survival

    20 years

  • clinical outcome

    20 years

  • Knee Osteoarthritis Outcome Score

    20 years

  • +4 more secondary outcomes

Study Arms (2)

Unicondylar Knee Arhtroplasty

EXPERIMENTAL

Operation with insertion of a knee arthroplasty using a unicompartmental device (Oxford phase 3, mobile bearing, uncemented)

Procedure: Unicondylar Knee Arthroplasty

Total Knee Arthroplasty

ACTIVE COMPARATOR

Operation with insertion of a knee arthroplasty using a total condylar device (PCR, nexgen with resurfacing, cemented)

Procedure: Total Knee Arthroplasty

Interventions

Unicondylar Knee ArthroplastyPROCEDURE

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.

Unicondylar Knee Arhtroplasty
Total Knee ArthroplastyPROCEDURE

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.

Total Knee Arthroplasty

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • knee instability caused by either cruciate or collateral ligament insufficiency,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Bispebjerg Hospital

Copenhagen, Bispebjerg, 2400, Denmark

Location

Randers Hospital

Randers, Central Jutland, 8920, Denmark

Location

Silkeborg Hospital

Silkeborg, Central Jutland, 8600, Denmark

Location

Gentofe Hospital

Copenhagen, Gentofte, 2900, Denmark

Location

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Aalborg Universitetshospital, Farsø

Farsø, 9640, Denmark

Location

Andreas Kappel

Farsø, Denmark

Location

Frederikshavn Sygehus

Frederikshavn, 9900, Denmark

Location

Næstved Sygehus

Næstved, 4700, Denmark

Location

Svendborg Sygehus

Svendborg, 5700, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

Related Publications (1)

  • Mortensen JF, Rasmussen LE, Ostgaard SE, Kappel A, Madsen F, Schroder HM, Odgaard A. Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. The study-protocol. BMC Musculoskelet Disord. 2019 Mar 20;20(1):119. doi: 10.1186/s12891-019-2508-1.

    PMID: 30894146DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Anders Odgaard, Consultant

    Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double Blinded, randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor, PhD-student

Study Record Dates

First Submitted

September 19, 2017

First Posted

January 11, 2018

Study Start

August 17, 2017

Primary Completion (Estimated)

October 16, 2041

Study Completion (Estimated)

October 16, 2041

Last Updated

October 23, 2023

Record last verified: 2023-10

Locations

DK(11)