TY - JOUR

T1 - Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis

T2 - the study-protocol

AU - Mortensen, Jacob Fyhring

AU - Rasmussen, Lasse Enkebølle

AU - Østgaard, Svend Erik

AU - Kappel, Andreas

AU - Madsen, Frank

AU - Schrøder, Henrik Morville

AU - Odgaard, Anders

PY - 2019

Y1 - 2019

N2 - Background: In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic. Methods: A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years. Discussion: Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded. PROMs: OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT. Trial registration: ClinicalTrials.gov ID: NCT03396640. Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.

AB - Background: In treatment of isolated medial unicondylar osteoarthritis of the knee, it is possible to choose between medial unicondylar knee arthroplasty (mUKA), or a total knee prosthesis (TKA). The demand for a blinded multicenter RCT with the comparison of mUKA and TKA has been increasing in recent years, to determine which prosthesis is better. Supporters of TKA suggest this treatment gives a more predictable and better result, whereas supporters of UKA suggest it is unnecessary to remove functional cartilage in other compartments. If the mUKA is worn or loosens, revision surgery will be relatively easy, whereas revision-surgery after a TKA can be more problematic. Methods: A double-blinded multicenter Randomized Clinical Trial setup is the aim of the study. 6 hospitals throughout all 5 municipal regions of Denmark will be participating in the study. 350 patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 20 years. Discussion: Results will be assessed in terms of 1) PROM-questionnaires, 2) Clinical assessment of knee condition, 3) cost analysis. To avoid bias, all participants except the theatre-staff will be blinded. PROMs: OKS, KOOS, SF36, Forgotten Joint Score, EQ5D, UCLA activity scale, Copenhagen Knee ROM scale, and Anchor questions. Publications are planned at 2, 5 and 10 years after inclusion of the last patient. The development of variables over time will be analyzed by calculating the area under the curve (AUC) for the variable relative to the initial value, and comparisons of the between-group differences will be based on parametric statistics. In this study, we feel that we have designed a study that will address these concerns with a well-designed double-blinded multicentre RCT. Trial registration: ClinicalTrials.gov ID: NCT03396640. Initial Release: 09/19/2017. Date of enrolment of first participant: 10/11/17.

KW - Anteromedial osteoarthritis

KW - Knee replacement

KW - Medial Unicondylar knee arthroplasty

KW - OKS

KW - Total knee arthroplasty

U2 - 10.1186/s12891-019-2508-1

DO - 10.1186/s12891-019-2508-1

M3 - Journal article

C2 - 30894146

AN - SCOPUS:85063261680

VL - 20

JO - B M C Musculoskeletal Disorders

JF - B M C Musculoskeletal Disorders

SN - 1471-2474

M1 - 119

ER -