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

Trials

Study Protocol

Rupert van Rooyen¹  Rob Sharp¹  Nina Zeng¹  Sherina Holland¹  Robert S. J. Elliott¹  Matthew L. Walker¹  Bill J. Farrington¹  Ali Bayan¹  Simon W. Young²  Mei Lin Tay² 

[1] Department of Orthopaedic Surgery, North Shore Hospital, Auckland, New Zealand;Department of Orthopaedic Surgery, North Shore Hospital, Auckland, New Zealand;Department of Surgery, University of Auckland, Auckland, New Zealand;

关键词: Total knee arthroplasty;    Cement fixation;    Cementless;    Aseptic loosening;    Radiolucencies;   

DOI  :  10.1186/s13063-022-06974-7

 received in 2021-12-09, accepted in 2022-12-02,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundTotal 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.MethodsThe 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.DiscussionWhile 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12616001624471. Registered trial name: Knee-Fix study (Cemented vs Uncemented Total Knee Replacement). Registered on 24 November 2016.

【 授权许可】

CC BY   
© The Author(s) 2022