| ObjectiveThe anterior cruciate ligament(ACL)is one of the most complex structures in the body.As the popularity of sports,The incidence of ACL injuries is also increasing.Although ACL reconstruction has obtained good result and the stability of knee was significantly improved.However,the growing demand for delicate biomechanics of ACL restoration cannot be met.Even with existing single-bundle anatomical reconstruction,double-bundle reconstruction or three-bundle reconstruction,a series of problems such as weakened hamstring muscle strength,pain in the anterior patellar area,high incidence of osteoarthritis after reconstruction,and poor recovery of proprioception will occur after Surgery.In recent years,it has been reported that the femoral side rupture of ACL repaired with internal brace had obtained excellent result in the mid-term follow-up.But the relevant animal experiments and clinical control experiments are lacking.This study is a prospective clinical controlled trial,including animal experiment and clinical study.In animal experiment,An model of modified Sherman type I injury of ACLwas prepared by using New Zealand white rabbits.In addition,a randomized controlled study was used to conduct ACL single-bundle anatomical reconstruction or ACL remnant primary repair combined with internal brace fixation.Biomechanical differences between the two groups were compared 6 months after operation.In the repair group,the healing of tendon and bone interfacial tissue was observed.In the clinical study,ACL primary repair with internal brace versus single-bundle anatomical reconstruction.The clinical efficacy of the two groups was assessed,so that providing a reliable method for the treatment of ACL injury.MethodsThis study includes two parts:animal experiment and clinical study.1.Animal experimentThirtyeight 12-week-old New Zealand white rabbits with body weight ranging from 2.0 to 2.5kg were used in this study.Eight of them were randomly selected to prepair An animal model of ACL modified Sherman type I injury by one knee joint.The remnant of ACL was repaired combined with internal brace fixation,with microfracture in the femoral foot-print,and no treatment was performed on the lateral knee.Shangke Huangshuiwas applied to both knees externally for two weeks.The histological healing status and the mechanical strength of the graft were evaluated post-operatively histological staining and tensile tests.In the remaining 30 New Zealand white rabbits,one knee was randomly selected for ACL remnat repair combined with internal brace fixation,and the femeral foot-print microfracture was performed,while the other side was performed with single-bundle anatomical reconstruction.Repair group:The ACL was dissected off proximally at the femeral foot-print,whereas the distally tibia attachment was left intact.The ACL remnant was repaired with 3-0 tedon Suture,and retain the Suture tail line.Microfracture was performed in the femeral ACL footprint and a 2mm diameter femoral and tibial tunnel was drilled.The Ultrabraid sutute as a internal brace was pulled into joint from tibial tunnel,and with Suture tail line together runs out the femoral tunnel.The femoral side was fixed with endobutton and the tibial side of the internal brace fixed to the bone through a drill hole in the bone with the knee at 30 degree of flexion.Reconstruction group:On the other knee,a median knee skin incision was made,1/3 of the medial patellar tendon,about 2.5mm wide,was harvested.Both ends of the graft were Sutured with 3-0 tendon Suture.Lateral dislocation of the patella,resection of synovial tissue and subpatellar fat pad,so that the anterior and posterior cruciate ligaments and meniscus were exposed.anterior drawer and Lachman test were positive after Complete resection of ACL.The tibial femoral tunnel were created with a 2mm drill bit through the ACL footprint.The graft and internal brace were pulled into the joint from tibia tunnel.The femoral side was fixed with endobutton and the tibial side fixed to the bone through a drill hole in the bone with the knee at 30 degree of flexion.After operation,the Lachman test and anterior drawer test of all the rabbits were negative.The affected knee was not fixed and was kept in cage freely.Each rabbit was given 400,000 units of penicillin intramuscular injection to fight infection after Surgery for three days.2.Clinical studyFrom April 2017 to May 2018,a total of 45 patients in the sports medicine department of foshan hospital of traditional Chinese medicine were included in the study according to the inclusion and exclusion criteria,including 22 in the repair group and 23 in the reconstruction group.Repair group:The ACL Sherman type I injury was confirmed again under arthroscopy,and the posterior lateral and anterior medial bundle of the ACL were Sutured respectively with a Suture passer.The posterior lateral bundle is fixed by an anchor,while the anterior medial bundle by an Endobutton.Three Ultrabraid sututes were folded into 12 strands and then suspended in the loop of endobutton for internal brace.Bone tunnels were drilled on the front and inside of the tibial foot print of the ACL,and then the internal brace was pulled out and tied in knots respectively.The position of the ACL and internal brace were appropriate.There was no impingement of knee when flexed and extensed.Reconstruction group:The graft adopts autologous hamstring muscle tendon,which is folded into 5 strands.The femoral side is pierced with a loop steel plate of 15mm endobutton.The femoral and tibial side were Sutured with 2 Ultrabraid sututes,and 4 taillines of femoral side were retained as internal brace.The graft was about 8.5cm long,The tibial tunnel was fixed with extruding screw and internal brace with cortical screw.All cases were followed up for 12 months after Surgery.All cases were followed up for 12 months after Surgery.IKDC score,Lysholm score,Tegner exercise level rating and kt-1000 unisilateral to affected lateral difference of the two groups were evaluated 3 months,6 months and 1 year after Surgery,respectively.MRI examination was conducted to evaluate the continuity of ligament in the two groups one year after Surgery.In the reconstruction group,cartilage degeneration,ligamentalization and tibial side cortical screw removal were routinely performed 1 year after Surgery.One year after the operation,the Opti-Knee which is three dimensional gait analysis system of knee joint was used to compare the differences of the forward and backward displacement,varus and valgus,internal and external rotation between two groups.SPSS20.0 software was used for data processing and statistical analysis(P<0.05 was considered statistically significant).Results1.Animal experimentA total of 40 New Zealand white rabbits were purchased,one of which died during anesthesia.Considering that it was caused by rapid drug injection,one died of knee joint infection 3 days after Surgery.A total of 38 rabbits were successfully enrolled.Six months after the operation,ACL continuity existed in the two groups with moderate tension and synovial covering on the ligament surface.No gap was found at the ACL ligament-bone interface,calcified fibrous cartilage connection was observed,and the endograft vascular formation was observed.There was no statistically significant difference in the maximum load measured by biomechanics at 6 months after operation between the two groups(repair group 85.18±6.15,Reconstruction group 83.98±7.24,P=0.49).The maximum tensile length and stiffness of the repair group were lower than that of the reconstruction group,and the differences were statistically significant(maximum tensile length:repair group 2.98±0.18,reconstruction group3.02±0.27,P=0.27;Stiffness:repair group 28.76±2.97,reconstruction group 26.93±2.88,P=0.01).2.Clinical studyThere were no statistically significant differences in preoperative general data(gender,age,injury to operation time,body mass index,combined meniscus injury)between the two groups.There was no statistically significant difference in IKDC objective score and Lysholm score between the two groups before operation.No postoperative infection or ligament retear were found in all patients.Three months after Surgery,IKDC objective score showed a statistically significant difference between the two groups(P=0.03),and the repair group was significantly better than the reconstruction group,mainly reflected in knee swelling and passive motion defects.The Lysholm score in the repair group was significantly better than that in the reconstruction group 3 months after Surgery,with statistically significant differences(P=0.00),which were mainly reflected in four aspects:knee pain,swelling,stair climbing,squatting.There was statistically significant difference in Tegner exercise level rating between the two groups(P=0.0),and the rehabilitation progress of the repair group was significantly faster than that of the reconstruction group.All patients in the repair group could perform light labor and walk on uneven roads 3 months after the Surgery,but the Tegner exercise level rating was significantly correlated with the recovery of postoperative muscle function and the physical exercise the patients had before the injury.The difference between the affected side and healthy side of KT-1000 in the two groups was statistically significant difference(P=0.01),and the stability of the knee joint in the repair group was better than that of the reconstruction group 3 months after the operation.Six months after Surgery,there was no statistically significant difference in Lysholm score between the two groups(6 months after Surgery:Lysholm score of 80.23±4.94 in the repair group and 78.22±5.38 in the reconstruction group,P=0.20).However,Lysholm score was better in the repair group than in the reconstruction group,and the differences between the two groups were still mainly reflected in pain,stair climbing and squatting.There was no statistically significant difference in IKDC objective score and Tegner exercise level rating 6 months after operation between the two groups(IKDC objective score:0.098,Tegner exercise level rating:P=0.51).The KT-1000 difference between the affected and healthy knee of patients in the two groups showed no statistically significant difference(2.72±0.96 in the repair group and 2.97±1.20 in the reconstruction group,P=0.44),and there was no significant difference in stability between the two groups.Twelve months after Surgery,there was no statistically significant difference in Lysholm score between the two groups(12 months after Surgery:Lysholm score in the repair group:90.27±3.62,and in the reconstruction group:88.39±5.39,P=0.17).There was no statistically significant difference in IKDC objective score and Tegner exercise level rating 12 months after operation between the two groups(IKDC objective score:0.77,Tegner exercise level rating:P=0.84).MRI review 12 months after Surgery in the two groups showed the presence of ACL continuity in all patients,and no obvious signs of cartilage injury in the repair group.The ACL MRI signal was higher than the posterior cruciate ligament,and the ligamentalization was still incomplete.In the reconstruction group,second look 12 months after the Surgery found synovial covering in 10 cases of type A,8 cases of type B,3 cases of type C,2 cases of type D,and the excellent and good rate was 78.2%.No synovial belt formation was observed on the graft surface during the operation,and the ligamentalization was consistent with the MRI results.The KT-1000 difference between the affected and healthy knee of patients in the two groups 12 months after Surgery showed no statistically significant difference(2.75±0.88 in the repair group and 3.18±1.28 in the reconstruction group,P=0.19),and there was no significant difference in the stability of the two groups.Both Surgical methods could restore the stability of the knee joint.Gait analysis was performed using the Opti-Knee system 12 months after Surgery showed no statistically significant difference in three-dimensional six degrees of freedom between the two groups(repair group Add/Abd:-1.46±2.64,reconstruction group Add/Abd:-1.29±3.86,P=0.23).repair group IE:2.42±5.72,reconstruction group IE:1.80±4.82,P=0.06.repair group FE:41.47±20.34,reconstruction group FE:42.21±18.36,P=0.67.repair group AP:3.21±5.22,reconstruction group AP:4.32±6.45,P=0.12.repair group ML:1.45±3.67,reconstruction group ML:-0.32±4.51,P=0.78.repair group DP 5.02±5.93,reconstruction group DP:8.96±5.11,P=0.08).ConclusionIn animal experiments,tendon and bone healing can be observed at the tendon and bone interface of the repair group,which can restore the stability of the knee joint.The clinical outcomes of arthroscopic primary repair of proximal ACL tears with internal brace and microfracture of foot print are excellent and are maintained at one year follow-up in a carefully selected subset of patients with Sherman type I tears and excellent tissue quality.Postoperative rehabilitation was faster in the ACL repair group than the reconstruction group.The second look showed that the injury of medial femoral condylar articular cartilage in the reconstruction group was worse than that before the operation 12 months after Surgery.In the knee rehabilitation,the internalbrace bears some stress and plays a role in protecting the graft. |
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