The latest research offers fresh insights into the effectiveness of a novel cementless mobile-bearing total knee arthroplasty (TKA) system. This comprehensive, prospective multicenter study focuses on the occurrence of radiolucent lines (RLLs) and their impact on clinical outcomes in patients with knee osteoarthritis. By closely observing these elements, the study aims to provide valuable data that could influence market access strategies for new TKA systems.
Study Overview
A total of seventy-eight patients undergoing primary TKA were included in this study. These patients were monitored over several timeframes: preoperative baseline, 6 weeks, 1 year, and 2 years post-surgery. The evaluation tools included the Knee injury and Osteoarthritis Outcome Score (KOOS), the Pain and Knee Injury Profile (PKIP), the 2011 Knee Society Score (2011KSS), and the EuroQol-5 Dimension-3 Level (EQ-5D-3L). The study highlights that significant improvements were noted in these patient-reported outcome measures (PROMs) at all postoperative checkpoints, with no reports of component loosening.
Radiolucent Lines and Clinical Outcomes
Initially, no RLLs were detected at the 6-week mark. However, RLLs measuring ≥ 1 mm developed in 2.8% of patients on the femoral side and 9.7% on the tibial side after one year. These percentages rose slightly to 5.7% and 10.9%, respectively, by the two-year follow-up. Despite the presence of RLLs, there was no correlation with changes in PROMs, suggesting that these lines did not significantly affect clinical outcomes. Furthermore, the study found that variables such as age, sex, body mass index, knee flexion range of motion, posterior cruciate ligament treatment, and β angle did not influence RLL occurrence.
Interestingly, the absence of intraoperative complications, revisions, or reoperations underscores the safety and efficacy of this TKA system. These findings are crucial for healthcare providers and policymakers considering the introduction of this new system into wider healthcare markets.
Key Inferences
- The new TKA system demonstrates a lower incidence of RLLs compared to previously reported systems, indicating improved implant stability.
- Improved PROMs across all time points suggest a high patient satisfaction rate, which can enhance market acceptance.
- The lack of significant correlation between RLLs and clinical outcomes may alleviate concerns about the clinical relevance of these lines.
- The absence of complications or need for reoperations supports the system’s safety profile, a vital factor for market access and regulatory approvals.
In conclusion, this study underscores the potential of the new cementless mobile-bearing TKA system to deliver favorable clinical outcomes with minimal complications. Such findings not only advocate for its clinical adoption but also pave the way for broader market access, benefiting both patients and healthcare providers.
Original Article:
Sci Rep. 2024 Sep 8;14(1):20902. doi: 10.1038/s41598-024-71806-4.
ABSTRACT
The objective of this study was to assess radiolucent lines (RLLs) and to determine their effect on clinical outcomes of the newly introduced cementless mobile-bearing total knee arthroplasty (TKA) system. This was prospective, multicentre study. Seventy-eight patients with knee osteoarthritis who underwent primary TKA were enrolled. Patient-reported outcome measures (PROMs) and radiographic assessments were evaluated at preoperative baseline and at 6 weeks, 1 year, and 2 years after surgery. KOOS, PKIP, 2011KSS, EQ-5D-3L and SKO improved from preoperative baseline to all postoperative timepoints, with no loosening of components. No RLLs were detected at 6 weeks after surgery. However, RLLs ≥ 1 mm developed in 2.8% of the patients for the femur and 9.7% for the tibia at 1 year after surgery, and values were 5.7% and 10.9%, respectively, at 2 years after surgery. RLL incidence was not correlated with PROMs. Age, sex, body mass index, range of motion knee flexion, posterior cruciate ligament treatment and β angle did not impact the occurrence of RLLs. There were no intraoperative complications, revisions or reoperations. This TKA system improved PROMs and showed less incidence of RLLs compared to the previous reported TKA without implant-related complications.
PMID:39245768 | DOI:10.1038/s41598-s41598-024-71806-4
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