Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Centre for Deformity Correction and Joint Preserving Surgery, Kliniek ViaSana, Mill, The Netherlands.
Cartilage. 2021 Apr;12(2):181-191. doi: 10.1177/1947603519828432. Epub 2019 Feb 13.
Both, knee joint distraction (KJD) and high tibial osteotomy (HTO) are joint-preserving surgeries that postpone total knee arthroplasty (TKA) in younger osteoarthritis (OA) patients. Here we evaluate the 2-year follow-up of KJD versus TKA and KJD versus HTO in 2 noninferiority studies.
Knee OA patients indicated for TKA were randomized to KJD ( = 20; KJD) or TKA ( = 40). Medial compartmental knee OA patients considered for HTO were randomized to KJD ( = 23; KJD) or HTO ( = 46). Patient-reported outcome measures were assessed over 2 years of follow-up. The radiographic joint space width (JSW) was measured yearly. In the KJD groups, serum-PIIANP and urinary-CTXII levels were measured as collagen type-II synthesis and breakdown markers. It was hypothesized that there was no clinically important difference in the primary outcome, the total WOMAC, when comparing KJD with HTO and with TKA.
Both trials were completed, with 114 patients (19 KJD; 34 TKA; 20 KJD; 41 HTO) available for 2-year analyses. At 2 years, the total WOMAC score (KJDTKA: +30.4 [95% CI 23.0-37.9] points; TKA: +42.4 [95% CI 38.1-46.8]; KJDHTO: +21.6 [95% CI 13.8-29.4]; HTO: +29.2 [95% CI 23.6-34.8]; all: P < 0.05) and radiographic minimum JSW (KJDTKA: +0.9 [95% CI 0.2-1.6] mm; KJDHTO: +0.9 [95% CI 0.5-1.4]; HTO: +0.6 [95% CI 0.3-0.9]; all: P < 0.05) were still increased for all groups. The net collagen type-II synthesis 2 years after KJD was increased ( < 0.05). Half of KJD patients experienced pin tract infections, successfully treated with oral antibiotics.
Sustained improvement of clinical benefit and (hyaline) cartilage thickness increase after KJD is demonstrated. KJD was clinically noninferior to HTO and TKA in the primary outcome.
膝关节牵开术(KJD)和高位胫骨截骨术(HTO)都是保留关节的手术,可以延缓年轻骨关节炎(OA)患者的全膝关节置换术(TKA)。在此,我们评估了 2 项非劣效性研究中 KJD 与 TKA 和 KJD 与 HTO 的 2 年随访结果。
需要 TKA 的膝关节 OA 患者被随机分为 KJD 组(n=20;KJD)或 TKA 组(n=40)。考虑行 HTO 的内侧间室膝关节 OA 患者被随机分为 KJD 组(n=23;KJD)或 HTO 组(n=46)。患者报告的结果指标在 2 年随访期间进行评估。每年测量放射学关节间隙宽度(JSW)。在 KJD 组中,测量血清 PIIANP 和尿 CTXII 水平,以作为 II 型胶原合成和分解的标志物。假设与 HTO 和 TKA 相比,KJD 在主要结局(总 WOMAC)方面没有临床重要差异。
两项试验均完成,114 例患者(19 例 KJD;34 例 TKA;20 例 KJD;41 例 HTO)可进行 2 年分析。2 年后,总 WOMAC 评分(KJDTKA:+30.4 [95%CI 23.0-37.9] 分;TKA:+42.4 [95%CI 38.1-46.8];KJDHTO:+21.6 [95%CI 13.8-29.4];HTO:+29.2 [95%CI 23.6-34.8];均:P<0.05)和放射学最小 JSW(KJDTKA:+0.9 [95%CI 0.2-1.6] mm;KJDHTO:+0.9 [95%CI 0.5-1.4];HTO:+0.6 [95%CI 0.3-0.9];均:P<0.05)在所有组中仍增加。2 年后 KJD 组的净 II 型胶原合成增加(P<0.05)。半数 KJD 患者发生针道感染,经口服抗生素成功治疗。
证明了 KJD 后临床获益和(透明)软骨厚度持续增加。KJD 在主要结局方面与 HTO 和 TKA 具有临床非劣效性。