| Abstract:objective:This subject executed preliminary clinical applicationabout the Lateral Malleolar Internal Fixators (patent number:ZL201020567872.3)which has been developed and completeed thebiomechanical testing. Through to the outcome of the fracture healing aftersurgery fixed and function rehabilitation,,to assessment the clinical applicationpossibility of LMIF, and provides an objective basis and technical support forthe clinical use in the later.Methods:1. Based on the experimental data before and LMIF (patent number: ZL201020567872.3), made several sets of lateral malleolar internal fixatorsand and the corresponding The material is titanium alloy.2.2007.7～2010.11we choose30lateral malleolar fracture patients from orthopedics and joints surgery of luzhou medical college affiliated hospital.19cases were male,11cases were female,19-60years old, averaged years32±3.4. Injury reason:cast sprain15cases, injury accident9cases, stubbed2cases, other4cases. The right side18cases, left side12cases.All were closed fractures. Simple lateral malleolar fracture19cases, medial and lateral ankles fracture11cases, lateral malleolar anteroinferior tibiofibular fractures and with joint ligament damage of Philip4cases, according to the Tscheme classification method for soft tissue injury0-2levels. According to Danis-Weber points type:Weber type B18cases, Weber C8cases, Weber type A4cases. Are not with serious composite damage, no severe heart, liver, kidney and other chronic disease, no pregnancy. The operation time4～20d after be injured, an average of6.5±2.8d.3. Thirty patients were randomly divided into A, B two groups, each group of15cases were selected LMIF ordinary steel (common plate CP), fixed. Preoperative score function of all patients with ankle, the Baird-Jackson standard..4.30patients, all choose peridural anesthesia and open reduction internal fixation operation. The first LMIF are all use to fixed, group B all use CP internal fixation, postoperative chief surgeon all by designated the doctor unified completed. Preoperative30min, use a amide class antibiotic postoperative,24to48hours after the pain relief postoperative, guidance of ankle passive activity, instructing patients on ankle active flex activities after3days, after two weeks both crutches don’t walk up load, gradually weight to walk in four to six weeks.5. Conventional dressing changes, suture removal, the observation of wound healing; record hospitalization time and cost of treatment.6. Within a week, after1,3,6,9and12months to review X-ray (both set at the same condition radiography), exist in mobile hard disk.7. Recorded in fixed removal time (fracture healing to clinical criteria, which fracture line disappear, the bone cortex through the fracture lines), internal fixation after requesting the fracture go2the bilateral lateral malleolar CT scan.8. Fixed removed within30days after surgery, use Baird-Jackson ankle rating system, party a and party b to two groups of postoperative ankle functional score9. Record complications of two groups.Results:1.30patients were followed up for9-20months, average of13.4±2.8months, no case was lost to follow-up,30patients after hospital discharge regularly, and phone to follow-up visit, door-to-door visits and regularly to the hospital visit on radiography.2. The expiration of the30patients from admission to follow-up with no deaths, nerve injuries, no built-in steel plate rejection. Group A non-surgery infection of the mouth, the plate is loose or broken and other complications; B2cases surgery mouth infection caused by the Category B healing,1patient plate and screw loosening With fixed March of the plaster eventually fracture healing legacy ankle pain trauma arthritis.3. The first time in8.73±1.53days, and revealed the hospitalization time10.80±3.47days, statistics processing P<0.01, there is a significant difference, show that the first statistical significance LMIF fixed hospitalization time obviously better than lateral malleolar revealed the fracture fixation of ordinary short cure time; The first hospitalization expenses,8819.53±600.55yuan, and revealed the hospitalization expenses,11098.33±732.21yuan, statistics processing P<0.05, there is a significant difference that the first LMIF statistical significance, fixed hospitalization expenses, and revealed the lateral malleolar fracture obviously better than ordinary steel plate fixation for costs less.4. Party A and B have two groups of callus growth quantitative indices statistics processing P<0.01, indicating that the first lateral malleolar fracture healing process of callus increased speed is lateral malleolar revealed the fracture healing callus increased faster. Postoperative fracture fixation, callus the time of most rapid growth is after one-June, statistics show that callus during the increase of quantitative index in a larger extent, more than the other months follow-up observation period.5. The first time LMIF fixed remove6.90±1.44months, and revealed the CP fixed time in10.00±3.19month removed, statistics processing P<0.05, statistically significant, explain the first LMIF fixed final fracture healing time than disarmament lateral malleolar revealed the steel plate fixation CP fracture healing plate after removal of short time, namely lateral malleolar fractures fixed with LMIF fracture healing fast. The CT score of the LMIF group was99.83±2.69%,and The CT score of the CP group was91.55±7.03%, statistics processing P<0.05, statistically significant, explain the fracture healing of the LMIF group were good than the fracture healing of the CP group after dislodged the internal fixation.6. Fixed removal of ankle30days after surgery, Group A ankle function score was96.80±2.81, B ankle function score was89.33±11.04points, raw data with two random independent samples t test, P<0.05there were significant differences, the description of the Group A steel plate removal after30days of the ankle joint functional recovery compared with Group B ankle functional recovery. B lateral malleolus fractures and internal fixation of postoperative complications in the CP3cases:were Grade B infection caused by the surgery mouth union in two cases, one cases of traumatic arthritis; Group A without complicationConclusion:1. Lateral malleolus mechanical properties of the holder system stability, apply to the adult lateral malleolus Weber, B and part of Weber, C, Weber. A fracture patients such as comminuted fracture, a special type of lateral malleolus fractures, osteoporosis is more applicable to fully meet the lateral malleolus accurate resetstable and fixed needs.2. Holder system operative within the lateral malleolus is simple, satisfactory reduction relative to shorten the three-dimensionalencircling fixation,postoperative bone callus fracture line, fracture healing, restore excellent limb function, significantly reduce complications, reduce length of stay.The costs are relatively lower, the clinical application to obtain satisfactory results. Lateral malleolus fixation device system is suitable for use in clinical practice. |
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