The Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty.

BACKGROUND: Total knee arthroplasty (TKA) is an effective procedure for patients with a variety of knee conditions. The main cause of aseptic TKA failure is implant loosening, which has been linked to poor cement mantle quality. Cementless components were introduced to offer better longer-term biological fixation through osseointegration; however, early designs led to increased rate of revision due to a lack of initial press-fit and bony ingrowth. Newer highly porous metal designs may alleviate this issue but randomised data of fully uncemented TKA (tibial, femoral, patella) is lacking. The aim of the Knee-Fix study is to investigate the long-term implant survival and patient outcomes of fully uncemented compared with cemented fixation in TKA. Our study hypothesis was that uncemented TKA would be as clinically reliable and durable as the gold-standard cemented TKA. METHODS: The Knee-Fix study is a two-arm, single-blinded, non-inferiority randomised controlled trial with 160 patients in each arm and follow-up at 6 weeks, 6 months, 12 months, 24 months, 5 years and 10 years. The primary outcome of interest is implant fixation, which will be measured by assessment of postoperative progressive radiolucencies with the Knee Society Total Knee Arthroplasty Roentgenographic Evaluation and Scoring System. Secondary outcome measures are patient-reported outcomes, measured using Oxford Knee Score (OKS), International Knee Society System (IKSS), Forgotten Joint Score-12 (FJS-12), EuroQol (EQ-5D-5L), VAS Pain, Patient Satisfaction Score and Net Promoter Score. DISCUSSION: While cemented fixation remains the gold standard, a growing proportion of TKA are now implanted cementless. Highly porous metal cementless components for TKA can offer several benefits including potentially improved biological fixation; however, long-term outcomes need further investigation. This prospective study will help discern long-term differences between the two techniques. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616001624471 . Registered trial name: Knee-Fix study (Cemented vs Uncemented Total Knee Replacement). Registered on 24 November 2016.

A Comparison of Walking Gait Following Mechanical and Kinematic Alignment in Total Knee Joint Replacement.

BACKGROUND: Although previous studies have compared radiological, pain, and function scores in kinematically aligned (KA) and mechanically aligned (MA) total knee arthroplasty (TKA), no previous studies have undertaken a three-dimensional (3D) gait analysis in these groups. This study compared kinematic and kinetic variables recorded during level walking in patients at least 2 years post-surgery who underwent an MA or KA procedure. METHODS: Utilizing a 9-camera motion analysis system, gait analysis was undertaken on 29 patients (MA = 15, KA = 14). A 9-camera motion analysis system was used to collect 3D kinematic data of the involved and uninvolved limbs during walking at a self-selected speed. Additionally, 3D ground reaction forces and moments during the stance phase were recorded, and an inverse dynamics approach was utilized to analyze these data. RESULTS: There were no significant differences in spatial-temporal variables between MA and KA groups (P > .05). Local minima and maxima for knee joint angles were not significantly different (P > .05) across involved and uninvolved legs and MA/KA groups in any of the 3 planes of motion. Principal component analysis revealed a significant difference (P < .05) in the transverse plane moment in late stance. No other significant differences were observed for knee, hip, or ankle joint moments. CONCLUSION: Differences in gait parameters across the KA and MA groups at 2 years post-surgery were insufficient to support either one of the operative procedures over the other.