Mineralized collagen-enhanced bone cement: A prospective, randomized controlled trial in total knee arthroplasty

Total knee arthroplasty (TKA) is a common procedure for end-stage osteoarthritis (OA). Traditional polymethylmethacrylate (PMMA) bone cement used in TKA has limitations, including lack of osteointegration and higher modulus than bone. We developed a novel bone cement, mineralized collagen (MC)-PMMA, to address these issues. In a prospective, randomized controlled trial, we compared TKA outcomes using MC-PMMA versus traditional PMMA (T-PMMA) in 34 patients with bilateral late-stage osteoarthritis. Evaluated parameters included patient-reported outcome measures (PROMs), knee range of motion, pain scores, complications, and radiographic evaluations over a 45.8-month follow-up. The MC-PMMA group showed significantly improved Knee Society function scores at one-year follow-up. No significant differences were found between groups in other PROMs, knee range of motion, or pain scores. Radiographic evaluations revealed no differences in postoperative Hip-Knee-Ankle (HKA) angle, anatomical axis angle, or radiolucent lines. Complication rates were similar, with no infections, aseptic loosening, peri-prosthetic fractures, or revisions. MC-PMMA is a promising biomaterial for TKA, offering comparable safety and mid-term clinical outcomes to T-PMMA. Its use may lead to earlier functional recovery, highlighting the potential of nanomaterials in orthopedic applications. Trial registration number: ChiCTR1800014811 (02/07/2018).