BackgroundIn 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.MethodsA 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.DiscussionResults 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.PROMsOKS, 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 registrationClinicalTrials.gov ID: NCT03396640.Initial Release: 09/19/2017.Date of enrolment of first participant: 10/11/17.
Tibial component overhang is known to be a contributor to worse outcomes in knee arthroplasty. The aim of this study is to investigate the presence of tibial component overhang, and whether overhang correlates to a higher local tenderness in both medial unicompartmental and total knee replacements. Also, to determine if a rotational projection phenomenon is presented with radiographs when investigating tibial component overhang. A prospective study, including 64 participants, was performed, where ultrasound measurements were compared with postoperative radiographs. Local tenderness was measured as a pressure pain threshold, determined at 3 months postoperatively using algometry. Sixty-two of sixty-four patients had an underdiagnosed medial overhang on radiographs, with a mean difference of 2.4 mm between radiographs and ultrasound (p < 0.001), presenting a rotational projection phenomenon. When comparing sites with ultrasound measured overhang to sites without overhang measured by ultrasound, a higher local tenderness was observed (p < 0.001). A positive linear correlation was found between patients' overhang and local tenderness (r = 0.2; p = 0.045). Subgroup analysis of medial overhang showed significantly higher tenderness than all other locations. No significant differences were seen for lateral overhang. An apparent rotational projection phenomenon of overhang on radiographs was seen, and a linear association between overhang and local tenderness was demonstrated. This study warrants the use of ultrasound when a surgeon is presented with a patient with postoperative medial tenderness, but no overhang can be seen on radiographs. It should also raise awareness of implant selection and positioning during surgery, especially avoiding the overhang to be localized directly medially.
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