Cartilage · 2019
Knee Joint Distraction Compared with High Tibial Osteotomy and Total Knee Arthroplasty: Two-Year Clinical, Radiographic, and Biochemical Marker Outcomes of Two Randomized Controlled Trials.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Jansen Mylène P, Besselink Nick J, van Heerwaarden Ronald J, Custers Roel J H, Emans Pieter J, Spruijt Sander, Mastbergen Simon C, Lafeber Floris P J G
Аннотация
OBJECTIVE: 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.
DESIGN: Knee OA patients indicated for TKA were randomized to KJD (n = 20; KJDTKA) or TKA (n = 40). Medial compartmental knee OA patients considered for HTO were randomized to KJD (n = 23; KJDHTO) or HTO (n = 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.
RESULTS: Both trials were completed, with 114 patients (19 KJDTKA; 34 TKA; 20 KJDHTO; 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 (P < 0.05). Half of KJD patients experienced pin tract infections, successfully treated with oral antibiotics.
CONCLUSIONS: 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.
DESIGN: Knee OA patients indicated for TKA were randomized to KJD (n = 20; KJDTKA) or TKA (n = 40). Medial compartmental knee OA patients considered for HTO were randomized to KJD (n = 23; KJDHTO) or HTO (n = 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.
RESULTS: Both trials were completed, with 114 patients (19 KJDTKA; 34 TKA; 20 KJDHTO; 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 (P < 0.05). Half of KJD patients experienced pin tract infections, successfully treated with oral antibiotics.
CONCLUSIONS: 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.