Wakelin Edgar A, Ponder Corey E, Randall Amber L, Koenig Jan A, Plaskos Christopher, DeClaire Jeffrey H, Lawrence Jeffrey M, Keggi John M
Corin Ltd., Raynham, MA, USA.
Oklahoma Sports and Orthopedics Institute, Edmond, OK, USA.
Knee Surg Sports Traumatol Arthrosc. 2023 Dec;31(12):5535-5545. doi: 10.1007/s00167-023-07601-x. Epub 2023 Oct 14.
The objective of this study was to determine if intra-operatively measured joint gaps are associated with 2-year pain outcomes in total knee arthroplasty (TKA) and whether balance and laxity windows could be defined throughout flexion to optimize 2-year pain outcomes. Our hypothesis is that intra-operative joint gaps are associated with 2 year post-operative pain outcome.
A prospective study investigating 310 robotically assisted TKAs was performed. Final intra-operative joint gap data were recorded using a digital tensioner and component alignment data were recorded by the robotics system. Patient demographics and Knee Injury and Osteoarthritis Outcome Score (KOOS) were recorded pre-operatively and KOOS and Hospital for Special Surgery (HSS) satisfaction were recorded at 2 years post-op. A random search Simulated Annealing (SANN) optimisation algorithm was used to determine global optimum laxity and balance windows at different flexion angles which maximized the 2-year KOOS pain scores. The windows were combined to determine the impact of achieving optimal laxity and balance throughout flexion. To improve clinical utility, boundaries identified by the SANN algorithm were rounded to the nearest 0.5 mm before statistical analysis.
Laxity and balance windows were defined in extension (Med lax: -2.0 to 2.5 mm, Lat lax: -0.5 to 2.5 mm, Balance: -3.0 to 0.0 mm), mid-flexion (Med lax: -1.0 to 2.5 mm, Lat lax: -0.5 to 3.0 mm, Balance: -2.0 to 2.0 mm), and flexion (Med lax: -2.0 to 3.5 mm, Lat lax: -2.0 to 1.5 mm, Balance: -3.0 to 3.0 mm). When all windows were satisfied, the greatest difference in KOOS pain score was observed (100.0 vs 94.4, p < 0.0001). The highest percentage of knees satisfying the Patient Acceptable Symptom State (PASS) for KOOS pain was also observed in knees which satisfied all windows compared to knees which did not (93% vs 71%, p = 0.0009). The proportion of knees which satisfy the PASS threshold decreased in knees which only satisfied 1-3 (29%) or 4-6 (69%) windows (p ≤ 0.0018). No optimal windows were found between component alignment and KOOS pain outcome (p ≥ 0.1180). High satisfaction was found across all groups (≥ 95%).
Intra-operatively measured joint gaps are associated with all KOOS sub-score outcomes at 2 years after TKA. Optimal windows for a clinically relevant improvement in post-operative KOOS pain were defined for laxity and balance but not for alignment indicating balance may have a greater impact on outcome than alignment.
II.
本研究的目的是确定全膝关节置换术（TKA）中术中测量的关节间隙是否与2年疼痛结局相关，以及是否可以在整个屈曲过程中定义平衡和松弛窗口以优化2年疼痛结局。我们的假设是术中关节间隙与术后2年疼痛结局相关。
进行了一项前瞻性研究，调查310例机器人辅助TKA。使用数字张力器记录最终术中关节间隙数据，机器人系统记录组件对齐数据。术前记录患者人口统计学和膝关节损伤与骨关节炎结局评分（KOOS），术后2年记录KOOS和特种外科医院（HSS）满意度。使用随机搜索模拟退火（SANN）优化算法确定不同屈曲角度下的全局最佳松弛和平衡窗口，以使2年KOOS疼痛评分最大化。将这些窗口合并以确定在整个屈曲过程中实现最佳松弛和平衡的影响。为提高临床实用性，在统计分析前将SANN算法确定的边界四舍五入到最接近的0.5毫米。
在伸直位（内侧松弛：-2.0至2.5毫米，外侧松弛：-0.5至2.5毫米，平衡：-3.0至0.0毫米）、屈曲中位（内侧松弛：-1.0至2.5毫米，外侧松弛：-0.5至3.0毫米，平衡：-2.0至2.0毫米）和屈曲位（内侧松弛：-2.0至3.5毫米，外侧松弛：-2.0至1.5毫米，平衡：-3.0至3.0毫米）定义了松弛和平衡窗口。当所有窗口均满足时，观察到KOOS疼痛评分的最大差异（100.0对94.4，p<0.0001）。与未满足所有窗口的膝关节相比，在满足所有窗口的膝关节中也观察到满足KOOS疼痛患者可接受症状状态（PASS）的膝关节百分比最高（93%对71%，p=0.0009）。仅满足1-3个（29%）或4-6个（69%）窗口的膝关节中满足PASS阈值的比例降低（p≤0.0018）。在组件对齐和KOOS疼痛结局之间未发现最佳窗口（p≥0.118）。所有组的满意度都很高（≥95%）。
术中测量的关节间隙与TKA术后2年所有KOOS子评分结局相关。定义了用于术后KOOS疼痛临床相关改善的松弛和平衡最佳窗口，但未定义对齐最佳窗口，表明平衡可能比对齐对结局的影响更大。
II级。
