| Purpose with the improvement of knee-sparing concept,more and more orthopedists and patients are willing to use high tibial osteotomy(HTO)to delay the progression of osteoarthritis,thereby delaying or not performing joint replacement.A HTO with reliable curative effect and few complications is urgently needed.through this prospective study,we evaluated the differences in perioperative observation indexes,imaging and knee joint function scores between the open high tibial osteotomy(OWHTO)and the closed high tibial osteotomy(CWHTO)in patients with knee osteoarthritis due to 10-15 varus deformity.Methods This research is prospective and divided into four steps.In the first step,the clinical data of previous OWHTO and CWHTO were collected from four aspects.First,the joint function was evaluated,including HSS score,WOMAC score,VAS score and NRS score.Second,radiographic evaluation including,mechanical axis(MA),hip-knee-ankle angle(HKAA),the femorotibial angle(FTA),the medial proximal tibial angle(MPTA),Joint line convergence angle(JLCA),Blackburne-Peel index(BP index),K-L classification,leg length disparity(LLD),and cartilage(MR)changes.Third,perioperative evaluation,including intraoperative bleeding volume,operation time,incidence of thrombosis,postoperative nerve damage,etc.Fourth,the impact on the surrounding joints,including bone healing in the osteotomy area,pain in the contralateral knee joint,and low back pain.The total number of samples to be included in the prospective experiments was calculated by statistical analysis of these data.The labels were then randomized,ensuring that patients were randomized and treated with either OWHTO or CWHTO using a simple randomization procedure.Unable to differentiate between the OWHTO and CWHTO groups,subjects were enrolled and assigned to the OWHTO and CWHTO groups via opaque sealed envelopes.Patients,investigators,and field personnel were unaware of the treatment assignment.The orthopedist operated on the participants after confirming the operation qualification,and the corresponding treatment procedures were completed according to the random grouping.In the second step,the baseline data of the enrolled patients were counted,and the imaging examinations were completed.The imaging observation indexes listed in the previous step were measured.The angle requiring correction on the coronal plane was calculated according to the Miniaci method.Patients who were enrolled were treated according to the treatment specification for each subgroup.Third,according to the follow-up plan,the patients’observation indexes were followed up regularly and the follow-up manual was filled in.After the patient’s follow-up period ended,the data were sealed.Statistical analysis was performed on the data after the follow-up visits of all patients were completed.Results Among the 230 patients who received HTO treatment in our hospital from October 2020 to December 2021 according to inclusive exclusion criteria,the OWHTO group and the CWHTO group were paired and randomized in a 3:1 ratio.Final OWHTO group consisted of 150 knees,105 knees for females,and 45 knees for males,with an average age of(59.9±6.9)years(range 49-70 years),71 knees on the left side and 79knees on the right side,height of(163.6±6.8)cm,(range 150-178 cm),weight of(74.4±11.4)kg,(range 44-94 kg),average body mass index of(27.7±3.3)kg/m~2(range19.0-34.4 kg/m~2)and K-L grade(2.6±0.5),(range II–III).In the CWHTO group,there were 31 males and 19 females,with the average age of(59.02±9.4)years,(range 43-70),left 29 knees and right 21 knees,height of(163.3±7.0)cm,(range 150-178 cm),weight of(74.4±9.4)Kg,(range 55-94)kg,BMI of(27.9±2.8)kg/m~2,(range 22.3-34.4 kg/m~2)and K-L grade(2.6±0.5),(range II–III).The HSS scores at 18 months postoperatively were(82.2±3.0)in the OWHTO group and(80.7±5.0)in the CWHTO group,(t=1.822,p=0.073),and there was no significant difference between the groups.The differences in WOMAC scores between the OWHTO group and the CWHTO group were(14.7±1.6)and(15.4±3.7)(t=1.861,p=0.064),respectively,and there was no statistical significance.The VAS scores in the OWHTO group and the CWHTO group were(1.6±0.4)and(1.9±0.9),respectively.The differences between the two groups were statistically significant(t=3.672,p=0.000),but the differences were not statistically significant.The NRS scores were(0.6±0.6)in the OWHTO group and(1.6±0.8)in the CWHTO group,(t=9.418,p=0.000).As for the imaging observation indexes evaluated 18 months after operation,the FTA values in the OWHTO group were(170.2°±0.8°)and that in the CWHTO group were(170.8°±1.4°),and the inter-group differences were statistically significant(t=3.758,p=0.000);the HKAA values in the OWHTO group were(179.7°±0.4°)and the CWHTO group were(179.3°±1.3°),and the inter-group differences were statistically significant(t=2.711,p=0.007).The percentages of MPTA in the OWHTO group and the CWHTO group were(91.7°±0.6°)and(91.8°±1.3°),respectively,and there was no significant difference between the groups(t=0.700,p=0.485).The values of JLCA in the OWHTO group and the CWHTO group were(2.3°±0.3°)and(2.4°±0.5°),respectively,and there was no significant difference between the groups(t=0.876,p=0.384).In the CWHTO group,the FTA values were(170.1±0.5)on the 2nd day and(170.8°±1.4°)on the 18th month after surgery,and the intra-group differences were statistically significant(t=3.006,p=0.004);those of HKA values were(179.7±0.5)on the2nd day and(179.3°±1.3°)on the 18th month after surgery,and the intra-group differences were statistically significant(t=2.758,p=0.008).The operation duration in the OWHTO group was(69.9±7.9)min,while that in the CWHTO group was(108.9±10.5)min.The hemoglobin values in the OWHTO group were(23.6±4.6)g/L and(28.3±6.0)g/L.The duration of surgery and the hemoglobin difference in the CWHTO group were greater than those in the OWHTO group.Adverse events such as bone nonunion in the osteotomy area and graft removal occurred in both groups.Superficial wound infection occurred in 1.3%(n=2)of patients in the OWHTO group,common peroneal nerve damage occurred in 4%(n=2)of patients in the CWHTO group on the third postoperative day,lower extremity force line loss occurred in 8%(n=4)of patients in the CWHTO group,and deep vein thrombosis occurred in 4%(n=2)of patients in the CWHTO group on the second postoperative day.The mean bone healing time in the osteotomy area of the CWHTO group was(3.7±0.6)months,with the range of(3–5)months,while that in the OWHTO group was(4.6±1.0)months,with the range of(3–6)months.(t=4.154,p=0.000).The difference in fracture healing time was statistically significant.The mean fracture healing time in the CWHTO group was less than that in the OWHTO group.Bone defects in osteotomy areas Bone defects occurred in 46 knees in the0WHTO group and not in the CWHTO group.Hinge fractures occurred in 13 knees in the OWHTO group and 4 knees in the CWHTO group.The pain in contralateral knees increased in 0WHTO group(31 knees)and 4 CWHTO groups(4 knees).There were 36knees in the 0WHTO group and 5 knees in the CWHTO group due to low back pain after HTO surgery.The LLD 18 months after surgery was(6.6±1.0)mm in the OWHTO group and(1.9±0.8)mm in the CWHTO group,and it was significantly smaller in the CWHTO group than in the OWHTO group(t=36.230,p<0.000).Conclusion Two osteotomies can effectively correct the force line of the lower limb,improve the function of the knee joint and alleviate the pain in the knee joint.There were small loss of FTA and HKA values at 18 months postoperatively for the CWHTO,with higher VAS and NRS scores for the CWHTO than for the OWHTO whose LLD was greater postoperatively.Both procedures have their own advantages.Facing the patients,we need to consider them individually.The CWHTO should be considered for correction of larger angle,and the LLD should be paid attention to after OWHTO surgery,so as to avoid the acceleration of OA progress of the contralateral knee joint. |
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