{"title":"使用金属支撑组件的单侧和双侧全膝关节置换术的中期比较评估：功能和临床效果评估","authors":"Ponnanna Karineravanda Machaiah , Supreet Bajwa , Ravi Teja Rudraraju , Kunal Aneja , Haresh P. Bhalodiya , Rakesh Kumar Singh , Vividh Makwana , Avtar Singh , Vivek Logani , Buddhadev Chatterjee , Devendra S. Solanki , Hemant Wakankar , Sanjeev Mahajan , Chandra-Shekhar Yadav , Ashokkumar Thakkar , Udita Chandra , Sanaa Ansari , Shivadharshni Sivakumar","doi":"10.1016/j.jorep.2024.100507","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><div>This prospective, post-marketing surveillance (PMS) study (Freedom 400) aimed to evaluate the clinical and functional outcomes of both unilateral and bilateral total knee arthroplasty (TKA) utilizing cruciate retaining/posterior stabilized (CR/PS) implants with metal-backed components (MBC).</div></div><div><h3>Methods</h3><div>Between November 2016 to January 2019, 408 patients underwent either unilateral or bilateral TKA at ten centers across India. Patients with primary end-stage osteoarthritis (OA) or inflammatory arthritis were included whereas, revision TKA patients were excluded from the study. Primary endpoints were 3-year implant survivorship and revision rates, with secondary endpoints including range of motion (ROM), Knee Society Score (KSS), and quality of life (QoL) assessed through WOMAC and SF-36 at 6 weeks, 6 months, 1- and 3 years.</div></div><div><h3>Results</h3><div>The study comprised 242 unilateral and 166 bilateral TKA patients, with an average age of 65.13 ± 8.35 and 64.34 ± 7.25 years, respectively. Both groups exhibited a mean body mass index of 27.13 ± 4.73 kg/m<sup>2</sup> and 27.80 ± 4.41 kg/m<sup>2</sup>. Female patients dominated the groups: 78.1 % and 86.75 % respectively, and the primary diagnosis was OA: 97.11 % and 96.39 %, respectively. Significant ROM improvement was observed in both groups (p < 0.001). Notable improvement was seen from baseline in mean clinical KSS (bilateral: 33.28 ± 15.84 to 91.06 ± 8.52, p < 0.001; unilateral: 31.26 ± 15.7 to 92.43 ± 8.07) and functional KSS (bilateral: 30.17 ± 21.19 to 98.50 ± 4.08, p < 0.001; unilateral: 26.59 ± 21.25 to 98.41 ± 4.33, p < 0.001) at 3 years. Baseline WOMAC scores among both the groups showed higher pre-operative values (25.78 and 23.91) which significantly lowered for pain (scores: 1.16 and 1.46), stiffness (scores: 0.53 and 0.68) and physical function (scores: 2.89 and 3.1) at 3 years indicating improved QoL. Similar significant trend was noted for SF-36 assessment (p < 0.001) in both the groups.</div></div><div><h3>Conclusion</h3><div>This PMS study concluded that unilateral and bilateral TKA using MBC yielded good outcomes and there was a significant improvement in ROM, KSS scores and QoL in patients with osteoarthritis-associated joint degeneration.</div></div>","PeriodicalId":100818,"journal":{"name":"Journal of Orthopaedic Reports","volume":"4 4","pages":"Article 100507"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative mid-term evaluation of unilateral and bilateral total knee arthroplasty utilizing metal-backed components: An assessment of functional and clinical outcomes\",\"authors\":\"Ponnanna Karineravanda Machaiah , Supreet Bajwa , Ravi Teja Rudraraju , Kunal Aneja , Haresh P. Bhalodiya , Rakesh Kumar Singh , Vividh Makwana , Avtar Singh , Vivek Logani , Buddhadev Chatterjee , Devendra S. Solanki , Hemant Wakankar , Sanjeev Mahajan , Chandra-Shekhar Yadav , Ashokkumar Thakkar , Udita Chandra , Sanaa Ansari , Shivadharshni Sivakumar\",\"doi\":\"10.1016/j.jorep.2024.100507\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><div>This prospective, post-marketing surveillance (PMS) study (Freedom 400) aimed to evaluate the clinical and functional outcomes of both unilateral and bilateral total knee arthroplasty (TKA) utilizing cruciate retaining/posterior stabilized (CR/PS) implants with metal-backed components (MBC).</div></div><div><h3>Methods</h3><div>Between November 2016 to January 2019, 408 patients underwent either unilateral or bilateral TKA at ten centers across India. Patients with primary end-stage osteoarthritis (OA) or inflammatory arthritis were included whereas, revision TKA patients were excluded from the study. Primary endpoints were 3-year implant survivorship and revision rates, with secondary endpoints including range of motion (ROM), Knee Society Score (KSS), and quality of life (QoL) assessed through WOMAC and SF-36 at 6 weeks, 6 months, 1- and 3 years.</div></div><div><h3>Results</h3><div>The study comprised 242 unilateral and 166 bilateral TKA patients, with an average age of 65.13 ± 8.35 and 64.34 ± 7.25 years, respectively. Both groups exhibited a mean body mass index of 27.13 ± 4.73 kg/m<sup>2</sup> and 27.80 ± 4.41 kg/m<sup>2</sup>. Female patients dominated the groups: 78.1 % and 86.75 % respectively, and the primary diagnosis was OA: 97.11 % and 96.39 %, respectively. Significant ROM improvement was observed in both groups (p < 0.001). Notable improvement was seen from baseline in mean clinical KSS (bilateral: 33.28 ± 15.84 to 91.06 ± 8.52, p < 0.001; unilateral: 31.26 ± 15.7 to 92.43 ± 8.07) and functional KSS (bilateral: 30.17 ± 21.19 to 98.50 ± 4.08, p < 0.001; unilateral: 26.59 ± 21.25 to 98.41 ± 4.33, p < 0.001) at 3 years. Baseline WOMAC scores among both the groups showed higher pre-operative values (25.78 and 23.91) which significantly lowered for pain (scores: 1.16 and 1.46), stiffness (scores: 0.53 and 0.68) and physical function (scores: 2.89 and 3.1) at 3 years indicating improved QoL. Similar significant trend was noted for SF-36 assessment (p < 0.001) in both the groups.</div></div><div><h3>Conclusion</h3><div>This PMS study concluded that unilateral and bilateral TKA using MBC yielded good outcomes and there was a significant improvement in ROM, KSS scores and QoL in patients with osteoarthritis-associated joint degeneration.</div></div>\",\"PeriodicalId\":100818,\"journal\":{\"name\":\"Journal of Orthopaedic Reports\",\"volume\":\"4 4\",\"pages\":\"Article 100507\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-10-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Orthopaedic Reports\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2773157X24002029\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Orthopaedic Reports","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2773157X24002029","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Comparative mid-term evaluation of unilateral and bilateral total knee arthroplasty utilizing metal-backed components: An assessment of functional and clinical outcomes
Objective
This prospective, post-marketing surveillance (PMS) study (Freedom 400) aimed to evaluate the clinical and functional outcomes of both unilateral and bilateral total knee arthroplasty (TKA) utilizing cruciate retaining/posterior stabilized (CR/PS) implants with metal-backed components (MBC).
Methods
Between November 2016 to January 2019, 408 patients underwent either unilateral or bilateral TKA at ten centers across India. Patients with primary end-stage osteoarthritis (OA) or inflammatory arthritis were included whereas, revision TKA patients were excluded from the study. Primary endpoints were 3-year implant survivorship and revision rates, with secondary endpoints including range of motion (ROM), Knee Society Score (KSS), and quality of life (QoL) assessed through WOMAC and SF-36 at 6 weeks, 6 months, 1- and 3 years.
Results
The study comprised 242 unilateral and 166 bilateral TKA patients, with an average age of 65.13 ± 8.35 and 64.34 ± 7.25 years, respectively. Both groups exhibited a mean body mass index of 27.13 ± 4.73 kg/m2 and 27.80 ± 4.41 kg/m2. Female patients dominated the groups: 78.1 % and 86.75 % respectively, and the primary diagnosis was OA: 97.11 % and 96.39 %, respectively. Significant ROM improvement was observed in both groups (p < 0.001). Notable improvement was seen from baseline in mean clinical KSS (bilateral: 33.28 ± 15.84 to 91.06 ± 8.52, p < 0.001; unilateral: 31.26 ± 15.7 to 92.43 ± 8.07) and functional KSS (bilateral: 30.17 ± 21.19 to 98.50 ± 4.08, p < 0.001; unilateral: 26.59 ± 21.25 to 98.41 ± 4.33, p < 0.001) at 3 years. Baseline WOMAC scores among both the groups showed higher pre-operative values (25.78 and 23.91) which significantly lowered for pain (scores: 1.16 and 1.46), stiffness (scores: 0.53 and 0.68) and physical function (scores: 2.89 and 3.1) at 3 years indicating improved QoL. Similar significant trend was noted for SF-36 assessment (p < 0.001) in both the groups.
Conclusion
This PMS study concluded that unilateral and bilateral TKA using MBC yielded good outcomes and there was a significant improvement in ROM, KSS scores and QoL in patients with osteoarthritis-associated joint degeneration.
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