Mid-term Outcomes of Patella Resurfacing During Total Knee Arthroplasty (TKA): Clinical, Functional, and Radiographic Insights.

Aim The primary objective of the study was to evaluate the mid-term implant survivability, rate of revisions, and clinical and functional outcomes following patella resurfacing during total knee arthroplasty (TKA) utilizing posterior stabilized (PS) total knee system (TKS). Methods A prospective, single-arm, multi-center, post-marketing surveillance encompassed patients with end-stage primary knee osteoarthritis (OA) or inflammatory arthritis. The time points of the study included baseline, six weeks, six months, one year, and three years post-operatively. Clinical outcomes included Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, Short Form-36 questionnaire (SF-36), and Knee Society Score (KSS) for quality of life (QoL). Radiographs assessed loosening, patella tracking, and implant longevity. Functional outcomes were assessed by range of motion (ROM). Result The study included 74 patients undergoing patella resurfacing during TKA with a PS all-poly component TKS at 10 centers in India. Among the study population, 85% were female, and the average age of the population was 65.13±7.20 years. End-stage OA (70 patients) and inflammatory arthritis (four patients) were the prevalent conditions. Patella sizes used were: 25 mm (n=1), 28 mm (n=29), 31 mm (n=40), and 34 mm (n=4). Primary outcomes showed implant survival was 100% with no revisions after three years. Local soft tissue infections and discomfort affected 3.2%, with no additional adverse events. Radiographs showed well-implanted patellar components with no misalignment or wear after three years. Secondary outcomes showed a significant three-year increase in mean ROM from 85.50°±15.02° to 122.45°±2.44°. After three years, clinical and functional KSS improved to 90.36±3.72 (baseline: 21.11±14.49) p<0.001 and 97.95±3.67 (baseline: 27.16±13.22) p<0.001, respectively. WOMAC values for pain, stiffness, and difficulty decreased significantly (p<0.001) over the three-year duration. SF-36 evaluating QoL showed substantial improvements (physical functioning, role limitation, and general health). Conclusion The study highlights the success of patella resurfacing during TKA, demonstrating excellent implant survival, improved functional outcomes, and QoL over a three-year period.
Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. Saviour Hospital Ethics Committee, Ahmedabad issued approval ECR/656/Inst/GJ/2014/RR-21 2026. The study was reviewed and approved by the local Institutional Review Boards at respective sites. Following are details of the Ethics Committee approval number of each site: (i) Saviour Hospital Ethics Committee, Ahmedabad - ECR/656/Inst/GJ/2014/RR-21 2026; (ii) Sangini Hospital Ethics Committee, Ahmedabad - ECR/147/Inst/GJ/2013/RR-19; (iii) Amandeep Hospital and Clinics Institutional Ethics Committee, Ludhiana - ECR/692/Inst/PB/2014/RR-20; (iv) Paras Hospital Ethics Committee, Gurugram - ECR/249/Inst/Har/2013/RR-19; (v) Apollo Gleneagles Hospital Institutional Ethics Committee, Kolkata - ECR/373/Inst/WB/2013/RR-19; (vi) Artemis Health Sciences Institutional Ethics Committee, Gurgaon - ECR/53/Inst/HR/2013/RR-19; (vii) Deenanath Mangeshkar Hospital and Research Centre Institutional Ethics Committee, Pune - ECR/15/Inst/Maha/2013/RR-22; (viii) Fortis Hospital Institutional Ethics Committee, Ludhiana - ECR/746/Inst/PB/2015/RR-22; (ix) All India Institute of Medical Sciences Institutional Ethics Committee, Delhi - ECR/538/Inst/DL/2014/RR-20. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: Ashok Kumar Thakkar declare(s) employment from Meril Life Sciences Private Limited, Gujarat, India. He is the Head of the Department of Clinical Research and Medical Writing and is a full-time employee of Meril Life Sciences Private Limited, Gujarat, India. Shivadharshni Sivakumar declare(s) employment from Meril Life Sciences Private Limited, Gujarat, India. She is a full time employee of Meril Life Sciences Private Limited, Gujarat, India. Udita Chandra declare(s) employment from Meril Life Sciences Private Limited, Gujarat, India. She is the Deputy General Manager of the Department of Clinical Research and Medical Writing and is a full-time employee of Meril Life Sciences Private Limited, Gujarat, India. Sanaa Ansari declare(s) employment from Meril Life Sciences Private Limited, Gujarat, India. She is a full-time employee of Meril Life Sciences Private Limited, Gujarat, India. Other relationships: The study is part of an ongoing “Freedom 400-PMS" study (CTRI No: CTRI/2016/11/007455) funded by Meril Life Sciences Private Limited, Vapi, Gujarat, India. Ashok Kumar Thakkar, Udita Chandra, Sanaa Ansari, and Shivadharshni Sivakumar are full-time employees of Meril Life Sciences Private Limited, Vapi, Gujarat, India. All other authors have no conflict of interest to declare related to the manuscript.
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