Odgaard Anders, Madsen Frank, Kristensen Per Wagner, Kappel Andreas, Fabrin Jesper
A. Odgaard Copenhagen University Hospital Gentofte, Hellerup, Denmark F. Madsen Aarhus University Hospital, Aarhus, Denmark P. Wagner Kristensen Vejle Hospital, Vejle, Denmark A. Kappel Aalborg University Hospital, Aalborg, Denmark J. Fabrin Zealand University Hospital, Køge, Denmark.
Clin Orthop Relat Res. 2018 Jan;476(1):87-100. doi: 10.1007/s11999.0000000000000017.
Controversy exists over the surgical treatment for severe patellofemoral osteoarthritis. We therefore wished to compare the outcome of patellofemoral arthroplasty (PFA) with TKA in a blinded randomized controlled trial.
QUESTIONS/PURPOSES: In the first 2 years after surgery: (1) Does the overall gain in quality of life differ between the implants based on the area under the curve of patient-reported outcomes (PROs) versus time? (2) Do patients obtain a better quality of life at specific points in time after PFA than after TKA? (3) Do patients get a better range of movement after PFA than after TKA? (4) Does PFA result in more complications than TKA?
Patients were eligible if they had debilitating symptoms and isolated patellofemoral disease. One hundred patients were included from 2007 to 2014 and were randomized to PFA or TKA (blinded for the first year; blinded to patient, therapists, primary care physicians, etc; quasiblinded to assessor). Patients were seen for four clinical followups and completed six sets of questionnaires during the first 2 postoperative years. SF-36 bodily pain was the primary outcome. Other outcomes were range of movement, PROs (SF-36, Oxford Knee Score [OKS], Knee injury and Osteoarthritis Outcome Score [KOOS]) as well as complications and revisions. Four percent (two of 50) of patients died within the first 2 years in the PFA group (none in the TKA group), and 2% (one of 50) became ill and declined further participation after 1 year in the PFA group (none in the TKA group). The mean age at inclusion was 64 years (SD 8.9), and 77% (77 of 100) were women.
The area under the curve (AUC) up to 2 years for SF-36 bodily pain of patients undergoing PFA and those undergoing TKA was 9.2 (SD 4.3) and 6.5 (SD 4.5) months, respectively (p = 0.008). The SF-36 physical functioning, KOOS symptoms, and OKS also showed a better AUC up to 2 years for PFA compared with TKA (6.6 [SD 4.8] versus 4.2 [SD 4.3] months, p = 0.028; 5.6 [SD 4.1] versus 2.8 [SD 4.5] months, p = 0.006; 7.5 [SD 2.7] versus 5.0 [SD 3.6] months, p = 0.001; respectively). The SF-36 bodily pain improvement at 6 months for patients undergoing PFA and those undergoing TKA was 38 (SD 24) and 27 (SD 23), respectively (p = 0.041), and at 2 years, the improvement was 39 (SD 24) and 33 (SD 22), respectively (p = 0.199). The KOOS symptoms improvement at 6 months for patients undergoing PFA and those undergoing TKA was 24 (SD 20) and 7 (SD 21), respectively (p < 0.001), and at 2 years, the improvement was 27 (SD 19) and 17 (SD 21), respectively (p = 0.023). Improvements from baseline for KOOS pain, SF-36 physical functioning, and OKS also differed in favor of PFA at 6 months, whereas only KOOS symptoms showed a difference between the groups at 2 years. No PRO dimension showed a difference in favor of TKA. At 4 months, 1 year, and 2 years, the ROM change from baseline for patients undergoing PFA and those undergoing TKA was (-7° [SD 13°] versus -18° [SD 14°], p < 0.001; -4° [SD 15°] versus -11° [SD 12°], p = 0.011; and -3° [SD 12°] versus -10° [SD 12°], p = 0.010). There was no difference in the number of complications. During the first 2 postoperative years, there were two revisions in patients undergoing PFA (one to a new PFA and one to a TKA).
Patients undergoing PFA obtain a better overall knee-specific quality of life than patients undergoing TKA throughout the first 2 years after operation for isolated patellofemoral osteoarthritis. At 2 years, only KOOS function differs between patients undergoing PFA and those undergoing TKA, whereas other PRO dimensions do not show a difference between groups. The observations can be explained by patients undergoing PFA recovering faster than patients undergoing TKA and the functional outcome being better for patients undergoing PFA up to 9 months. Patients undergoing PFA regain their preoperative ROM, whereas patients undergoing TKA at 2 years have lost 10° of ROM. We found no differences in complications.
Level I, therapeutic study.
对于重度髌股关节炎的手术治疗存在争议。因此，我们希望在一项双盲随机对照试验中比较髌股关节置换术（PFA）与全膝关节置换术（TKA）的疗效。
问题/目的：在术后的前2年：（1）基于患者报告结局（PRO）随时间变化曲线下面积，两种植入物的总体生活质量改善情况是否存在差异？（2）PFA术后特定时间点的患者生活质量是否优于TKA术后？（3）PFA术后患者的活动范围是否大于TKA术后？（4）PFA导致的并发症是否比TKA更多？
符合条件的患者需有使人衰弱的症状且患有孤立性髌股疾病。2007年至2014年纳入了100例患者，并随机分为PFA组或TKA组（第一年双盲；对患者、治疗师、初级保健医生等双盲；对评估者半盲）。患者接受了4次临床随访，并在术后的前2年完成了6套问卷。SF-36身体疼痛是主要结局。其他结局包括活动范围、PRO（SF-36、牛津膝关节评分[OKS]、膝关节损伤和骨关节炎结局评分[KOOS]）以及并发症和翻修情况。PFA组有4%（50例中的2例）患者在术后前2年内死亡（TKA组无死亡病例），PFA组有2%（50例中的1例）患者在术后1年后患病并拒绝进一步参与研究（TKA组无此类情况）。纳入时的平均年龄为64岁（标准差8.9），77%（100例中的77例）为女性。
PFA组和TKA组患者SF-36身体疼痛在2年内的曲线下面积（AUC）分别为9.2（标准差4.3）个月和6.5（标准差4.5）个月（p = 0.008）。与TKA相比，PFA组在2年内的SF-36身体功能、KOOS症状和OKS的AUC也更好（分别为6.6[标准差4.8]个月对4.2[标准差4.3]个月，p = 0.028；5.6[标准差4.1]个月对2.8[标准差4.5]个月，p = 0.006；7.5[标准差2.7]个月对5.0[标准差3.6]个月，p = 0.001）。PFA组和TKA组患者在术后6个月时SF-36身体疼痛的改善分别为38（标准差24）和27（标准差23）（p = 0.041），在术后2年时，改善分别为39（标准差24）和33（标准差22）（p = 0.199）。PFA组和TKA组患者在术后6个月时KOOS症状的改善分别为24（标准差20）和7（标准差21）（p < 0.001），在术后2年时，改善分别为27（标准差19）和17（标准差21）（p = 0.023）。KOOS疼痛、SF-36身体功能和OKS从基线的改善在术后6个月时也有利于PFA组，而在术后2年时只有KOOS症状在两组间存在差异。没有PRO维度显示有利于TKA组。在术后4个月、1年和2年时，PFA组和TKA组患者相对于基线的活动度变化分别为（-7°[标准差13°]对-18°[标准差14°]，p < 0.001；-4°[标准差15°]对-11°[标准差12°]，p = 0.011；以及-3°[标准差12°]对-10°[标准差12°]，p = 0.010）。并发症数量没有差异。在术后的前2年，PFA组有2例患者进行了翻修（1例翻修为新的PFA，1例翻修为TKA）。
对于孤立性髌股关节炎患者，在术后的前2年，接受PFA的患者比接受TKA的患者获得更好的总体膝关节特异性生活质量。在术后2年时，但只有KOOS功能在接受PFA和接受TKA的患者之间存在差异，而其他PRO维度在两组间没有差异。这些观察结果可以解释为接受PFA的患者比接受TKA的患者恢复得更快，并且在长达9个月的时间里接受PFA的患者功能结局更好。接受PFA的患者恢复到术前的活动度，而接受TKA的患者在术后2年时活动度丧失了10°。我们发现并发症方面没有差异。
I级，治疗性研究。
