| ObjectiveThe aim of this study is to observe the application value and clinical efficacy of protective weight-bearing in the process of comprehensive Traditional Chinese Medicine(TCM)hip preservation treatment for osteonecrosis of the femoral head(ONFH).The study analyzes whether factors such as the type and duration of protective weight-bearing have a significant impact on the progression of femoral head joint surface collapse after hip preservation.Using biomechanical testing methods and Raman spectroscopy technology,the study explores the differences in the microstructure,chemical composition,and mechanical properties of bone trabeculae in different regions of the ONFH,in order to investigate the potential internal and external factors contributing to bone trabecular fracture and femoral head joint surface collapse after necrosis.Finally,the study combines the fitting results of the nonlinear creep function model to evaluate the strain-time change trend of bone trabeculae under different stress conditions,providing a reference for the development of a standardized implementation plan for protective weight-bearing.Methods1.Through evidence-based medical research,we systematically evaluated the clinical effectiveness and application value of protective weight-bearing in the process of comprehensive TCM hip preservation treatment,and analyzed the differences between the outcomes of total hip arthroplasty rate,collapse rate,hip Harris score,and VAS score after treatment by comparing protective weight-bearing with hip preservation surgery.2.The clinical efficacy of comprehensive TCM hip preservation treatment for ONFH was analyzed in the form of a retrospective case series study by collecting clinical data and follow-up information of patients,comparing the results of hip Harris score,iHOT-12,WOMAC and VAS score before and after treatment,and analyzing the improvement of clinical symptoms of patients with comprehensive TCM hip preservation treatment.Also comparing the clinical efficacy of patients at the first visit and at the same time,the hip radiological data of patients at the first visit and at the last follow-up,including ARCO stage,JIC classification,lesion size and collapse degree,were compared and subgroup analysis was performed to analyze the effect of comprehensive TCM hip preservation treatment on the changes of hip radiological results.3.Patients treated with comprehensive TCM hip preservation therapy were grouped into progressive and non-progressive groups according to whether the degree of collapse progressed after treatment.And the risk factors that might influence whether the degree of collapse progressed during this therapy were analyzed in the form of a retrospective casecontrol study,in which the potential factors related to protective weight-bearing were classified,including the type of walking aid,the time and scenario of use,etc.,with a view to providing a clinical basis for the development of a standardized protective weight-bearing operation procedure.4.Uniaxial compression test was used to determine the mechanical properties of stress trabeculae in the femoral neck fractures and the ONFH under different preparation and storage conditions.And the stressed trabeculae were subjected to Micro-CT scan to measure the microstructural differences in the quality and quantity of trabeculae in different parts of the femoral head.The differences in microstructure such as quality and quantity of bone trabeculae in different parts of the bone,and then analyze whether there is a correlation between the changes in mechanical properties of bone trabeculae and the changes in microstructure after stress.5.The femoral head after necrosis was divided into subchondral bone zone,necrotic bone zone and stress trabecular zone.The chemical composition of the trabecular bone in different areas was detected using microscopic laser Raman imaging technology.The relative mineralization level,crystallinity of hydroxyapatite,and degree of carbonate substitution between trabecular bones in different areas were compared and analyzed to clarify the chemical composition changes in trabecular bone structure in different areas after necrosis.6.The maximum compressive load of the necrotic bone was measured using uniaxial compression testing.The maximum compressive load of the stress trabecular bone was also measured and used as a constant load condition for two groups of trabecular bone samples.Compression creep testing was then performed.The creep strain-time relationship of the stress trabecular bone was compared and analyzed.The data was fitted and validated using a known nonlinear creep function model.This allowed for an analysis of the creep trend and strain level of the trabecular bone under different load conditions.Results1.A total of 813 patients(1025 hips)were included in 14 articles in this study.The results indicated that there was no statistically significant difference in the efficacy between the protective weight-bearing group and the surgical group in terms of total hip arthroplasty rate,collapse rate,hip Harris score,and VAS score.A single-arm meta-analysis of the clinical efficacy of the protective weight-bearing group showed a hip joint arthroplasty rate of 40%,a collapse rate of 46%,an average Harris score of 80.86 points,and an average VAS score of 1.00 point.The Harris score results at the 3,6,12,and 24-month follow-up were 79.93 points,83.94 points,85.94 points,and 96.09 points,respectively.The VAS score results at the 6 and 12-month follow-up were 2.20 points and 1.29 points,respectively.2.A total of 73 patients(119 hips)with ONFH treated with comprehensive TCM hip preservation therapy were retrospectively analyzed in this study,with a mean follow-up time of 41.58 ± 26.92 months.The results of the hip Harris score,iHOT-12,VAS and WOMAC scores,which reflect clinical symptoms,were significantly better at the last follow-up than before treatment(P<0.05).There was a significant progression in ARCO staging and collapse degree after treatment compared with pre-treatment(P<0.05),while the distribution of JIC classification and lesion size after treatment was not significantly different from that at the initial visit.The overall hip preservation success rate was 90.76%,with 97.67%,91.53%and 70.59%for ARCO stage Ⅰ&Ⅱ,Ⅲa and Ⅲb,respectively(P<0.05);and 93.37%,92.59%and 77.78%for JIC type A&B,C1 and C2,respectively(P<0.05).The success rates of hip preservation for collapse≤2 mm and>2 mm were 94.12%and 70.59%,respectively(P<0.05).There was no significant difference between the success rates of hip preservation for different lesion size.The VAS score results of ARCO stage Ⅲa&b were significantly inferior to the score results of ARCO stage Ⅰ&Ⅱ(P<0.05).The iHOT-12,WOMAC and VAS score results were significantly better for lesion size<15%(P<0.05).3.The results of the case-control study showed a total of 53 hips in the collapse progression group and 66 hips in the non-progression group.The type,scenario,duration and iHOT-12 score of protective weight-bearing were significantly negatively correlated with femoral head collapse progression(P<0.05).The duration of conservative treatment,VAS score,ARCO staging,JIC staging and necrosis extent size were significantly and positively correlated with femoral head collapse progression(P<0.05).Binary logistic regression showed that the higher the iHOT-12 score,the lower the risk of progression of collapse occurring,and the larger the extent of necrosis,the higher the risk of progression of collapse occurring(P<0.05).The use of crutches or canes significantly reduced the incidence of collapse progression compared with patients who did not use protective weight-bearing measures(P<0.05),and the risk of collapse progression was lower in patients who performed protective weight-bearing both indoors and outdoors,while the risk increased in patients who used it only outdoors or occasionally.The risk of collapse progression was not well controlled in patients who used it for more than 6 months(P<0.05).Although neither ARCO staging nor JIC classification had a significant effect on the risk of it,there was a trend toward increased risk of collapse progression with increasing staging.Protective weight-bearing time,scenario,type,duration of conservative treatment,iHOT-12,ARCO staging,JIC classification,and lesion size had relatively moderate predictive power for whether femoral head collapse progressed,with the best performance being the lesion size(AUC=0.724).4.Among all mechanical properties and microstructural parameters,there were no significant differences in the results between the paraformaldehyde and saline groups,and no statistically significant differences among the three geometries.Dy and Df were significantly lower in the steroid group than in the normal group(P<0.05).Bottom and Total(BV/TV,Tb.Th)were significantly higher(P<0.05)and Fracture,Bottom and Total(BS/BV)were significantly lower(P<0.05)in the steroid group compared to the alcohol and normal groups.The correlation between load variables(F),stiffness and work and microstructure parameters are more significant,especially for Top,Fracture and Total(BV/TV,BS/BV and Tb.Th).5.The results of the analysis of the mean Raman spectral characteristic peaks showed that the PO43-wave peaks of the specimens in the steroid group were sharper and more intense compared to the normal and alcohol groups.In the normal group,the CO32-/PO43-integrated area ratio was significantly higher and the 1/FWHM,PO43-/Amide Ⅲ and PO43-/Amide Ⅰintegrated area ratios were significantly lower in the subchondral bone compared to the stressed bone trabeculae(P<0.05).In the steroid group,the PO43-/Amide Ⅱ integral area ratio was significantly lower in stressed bone trabeculae than in necrotic bone(P<0.05),and 1/FWHM was significantly lower in both subchondral bone and necrotic bone(P<0.05).In the alcohol group,the 1/FWHM of stressed bone trabeculae was significantly lower than that of necrotic and subchondral bone,respectively(P<0.05).In necrotic bone,there was no significant difference between the results of the hormone and alcohol groups.In subchondral bone,the PO43-/Amide III and PO43-/Amide Ⅰ integral area ratios were significantly higher in the steroid and alcohol groups compared to the normal group(P<0.05),and the PO43-/AmideⅡ integral area ratio was significantly higher in the alcohol group(P<0.05).In the stressed trabeculae,the CO32-/PO43-and PO43-/Amide I integral area ratios were significantly higher in the steroid and alcohol groups(P<0.05),the PO43-/Amide Ⅱ integral area ratio was significantly higher in the steroid group(P<0.05),and the 1/FWHM was significantly lower in the steroid and alcohol groups(P<0.05)compared with the normal group.This indicates that the bone quality of the trabeculae of the femoral head is significantly lower after the occurrence of necrosis,with increased brittleness,reduced collagen content,weakened impact resistance,sclerosis and thickening of the stressed trabeculae,and subchondral bone more prone to fracture.6.In this study,the average maximum compressive load of bone trabeculae in the necrotic area was 1100.85±178.56 N by uniaxial compression testing.The creep strain-time curve results of the two groups showed that when subjected to a load of 900 N,the creep strain of bone trabeculae first increased rapidly and then entered a period of constant-rate creep.When the load was 1100 N,the creep strain of the bone trabeculae first increased slowly and then entered into a constant-rate creep period without accelerated creep.The results of the fit of the nonlinear creep model function showed that the greater the load on the bone trabeculae,the more likely it was to fracture significantly within a short period of time,and the degree of fracture showed a continuous trend of increasing.Conclusion1.Protective weight-bearing treatment can achieve clinical efficacy that is not inferior to hip preservation surgery.2.Protective weight-bearing treatment can reduce the risk of femoral head collapse progression during hip preservation treatment,helping early-stage patients achieve "survival with collapse" and avoiding total hip arthroplasty.3.After necrosis,the fragility of the femoral head bone structure increases,the toughness decreases,the proportion of mineralization increases,and the content of collagen decreases.Significant changes in the mechanical strength and creep properties of bone trabeculae,mainly necrotic and subchondral bones,are the internal causes of bone trabecular fracture and femoral head collapse.4.The newly formed repair bone tissue is not sufficient to bear the physiological load at the previous level,and repeated and sustained large stress is the external cause of the progression of femoral head collapse.5.Protective weight-bearing can directly reduce the external force on the femoral head,slow down the creep speed of bone trabeculae,and thus control the degree of bone trabecular deformation and fracture. |
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