Background

A number of total knee arthroplasty (TKA) systems are used across a variety of markets in which outcome will be influenced by patient factors, surgical technique and implant characteristics. The aim of the current study was to report the early functional results of a primary TKA system in support of the component design characteristics adapted for achieving increased functional expectations of the patients.

Materials and Methods

A prospective, continuous series of 304 primary posterior-stabilized (PS) TKAs were performed in 208 patients by a single surgeon. Inclusion criterion was patients undergoing primary TKA with Freedom Total Knee system and willing to participate in the study. Exclusion criteria were patients undergoing revision TKA, patients not willing to participate and patients who were lost to follow-up. Patients were clinically and radiologically assessed for a minimum of 5 years post-operatively. Oxford Knee score (OKS) and range of motion (ROM) were assessed for the entire study population and by gender.

Results

There were no patients who were lost to follow-up. Two patients (Two knees) required incision and secondary suturing for superficial skin wound complication. At minimum 5-year follow-up, there was no radiographic evidence of component loosening/failure. Clinical evaluation at 5 years post-operatively showed statistically significant increase in the OKS and ROM as compared to pre-operative values (OKS pre-operative 19.27 ± 1.86, post-operative 38.76 ± 1.5, p value < 0.001, ROM pre-operative 94.57 ± 3.49, post-operative 127.69 ± 3.65, p value < 0.001). There was no statistically significant difference in the clinical outcome between male and female genders as well as between unilateral and bilateral TKA.

Conclusion

The study showed encouraging early results for the bone-conserving high flexion TKA system in 208 patients at minimum 5-year follow-up. The adapted design characteristics for improved functional expectations are confirmed in this reported Indian population study group cohort. Further continued evaluation is warranted for this primary TKA system across Indian and other ethnic population.

中文翻译：

---

印度人群保骨高屈曲后稳定全膝关节系统的早期结果

背景

许多全膝关节置换术 (TKA) 系统应用于各种市场，其结果将受到患者因素、手术技术和植入物特性的影响。当前研究的目的是报告主要 TKA 系统的早期功能结果，以支持组件设计特征，以实现患者更高的功能期望。

材料和方法

由一名外科医生对 208 名患者进行了一项前瞻性、连续的 304 例初次后稳定 (PS) TKA 手术。纳入标准是接受采用 Freedom 全膝关节系统初次全膝关节置换术并愿意参与研究的患者。排除标准是接受翻修 TKA 的患者、不愿意参与的患者以及失访的患者。术后至少 5 年对患者进行临床和放射学评估。对整个研究人群按性别进行牛津膝关节评分 (OKS) 和活动范围 (ROM) 评估。

结果

没有患者失访。两名患者（两膝）因浅表皮肤伤口并发症需要切开并二次缝合。在至少 5 年的随访中，没有发现部件松动/失效的放射线证据。术后 5 年的临床评估显示，与术前相比，OKS 和 ROM 显着增加（术前 OKS 19.27 ± 1.86，术后 38.76 ± 1.5，p 值 < 0.001，ROM 术前94.57 ± 3.49，术后 127.69 ± 3.65，p值 < 0.001）。男性和女性之间以及单侧和双侧TKA之间的临床结果没有统计学上的显着差异。

结论

该研究显示，在至少 5 年的随访中，208 名患者的骨保留高屈曲 TKA 系统取得了令人鼓舞的早期结果。为改善功能预期而调整的设计特征在本报告的印度人口研究组队列中得到了证实。需要对印度和其他种族人群的这一主要全膝关节置换系统进行进一步的持续评估。