TY - JOUR
T1 - Randomized clinical trial of medial unicompartmentel versus total knee arthroplasty for anteromedial tibio-femoral osteoarthritis. 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 - 2019/3/20
Y1 - 2019/3/20
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 - Adolescent
KW - Arthroplasty, Replacement, Knee/methods
KW - Child
KW - Child, Preschool
KW - Double-Blind Method
KW - Female
KW - Femur/diagnostic imaging
KW - Follow-Up Studies
KW - Humans
KW - Infant
KW - Infant, Newborn
KW - Male
KW - Osteoarthritis, Knee/diagnostic imaging
KW - Prospective Studies
KW - Tibia/diagnostic imaging
KW - Young Adult
U2 - 10.1186/s12891-019-2508-1
DO - 10.1186/s12891-019-2508-1
M3 - Protocol
C2 - 30894146
SN - 1471-2474
VL - 20
SP - 119
JO - BMC Musculoskeletal Disorders
JF - BMC Musculoskeletal Disorders
IS - 1
ER -