Midterm Results After Coated and Uncoated TKA: A Randomized Controlled Study

Area of Science:

• Orthopedics
• Biomaterials Science
• Medical Engineering

Background:

• Patients with metal hypersensitivity undergoing total knee arthroplasty (TKA) often require specialized hypoallergenic implants.
• Coating standard TKA implants is a potential strategy to mitigate hypersensitivity concerns.
• The clinical benefit of these costly coated implants remains uncertain despite in vitro evidence of reduced polyethylene wear.

Purpose of the Study:

• To evaluate the clinical efficacy and safety of a novel 7-layer-coated TKA implant compared to a standard TKA implant.
• To assess patient-reported outcomes and implant survival rates in patients receiving coated versus standard TKA implants.

Main Methods:

• A randomized controlled trial involving 120 patients undergoing TKA.
• Patients were assigned to receive either a novel 7-layer-coated implant or a standard TKA implant.
• Outcomes measured included implant survival, Oxford Knee Score, and adverse events over midterm follow-up.

Main Results:

• The 5-year estimated survival rate was 100% for the coated group and 98.1% for the standard group (one revision in the standard group).
• Both groups demonstrated substantial improvement in Oxford Knee Score, with mean scores increasing from approximately 21.7 preoperatively to 39.2 postoperatively.
• No adverse effects were observed with the new coating during the midterm follow-up period.

Conclusions:

• The novel 7-layer-coated TKA implant appears safe and provides comparable clinical benefits to standard implants in the midterm.
• Further long-term follow-up is necessary to ascertain any definitive advantages of the coated implant over standard TKA.
• The study highlights the need for continued investigation into the long-term efficacy of coated TKA implants for patients with metal hypersensitivity.