The re-evaluation of the effectiveness of new drugs is of great importance when they are in post-market for there exist some limitations in clinical trials before these drugs are put on the market. The large sample multi-centre randomized controlled trial is the best method of re-evaluation of the effectiveness of new drugs. It could appropriately evaluate not only the large-term efficacy and safety of drugs, but the treatment effect on the survival state and its complications as well. This method will also lead to a great social amp; economic benefit.
Abstract: Objective To discuss the security, effectiveness and risk factors of videoassisted thoracoscopic surgery for posterior mediastinal tumors. Methods We retrospectively analyzed the data of 59 patients including 36 men and 23 women who underwent thoracoscopic resection of posterior mediastinal tumors in People’s Hospital of Peking University from May 2001 to July 2009. Their age ranged from 6 to 73 years old with an average age of 40.6 years old. The average maximum diameter of the tumors was 4.86 cm. All procedures were performed under general anesthesia and tumors were cut out with three ports. The anterior port was extended to 6 to 10 cm when conversion to thoracotomy was needed. After mediastinal pleura were opened, the tumor was stripped out along the outside of peplos and the vascular pedicle nerves were managed respectively. Results All surgeries were carried out successfully. The surgical duration, perioperative blood loss, postoperative chest tube duration and postoperative stay in hospital were respectively 45-300 min(125.80±57.40 min), 10-1 000 ml(168.10±157.70 ml), 1-10 d(2.50±1.74 d), and 2-14 d(5.24±2.24 d). There were 6 cases of conversion to open thoracotomy with a conversion rate of 10.2%. Postoperative pathology showed that there were 46 cases of neurogenic tumors, 10 cases of cyst, 2 cases of teratoma, and 1 case of lipoma. Follow-up was done on 51 cases for a period of 7-108 months(55.0±24.0 months) and 8(13.6%) cases were missed out during the period. No recurrence or death occurred during the followup. Logistic multivariable analysis showed that maximum diameter of the tumor ≥6 cm was the independent risk factor for extending operative time (OR=1.932，P=0.004), increasing perioperative blood loss (OR=2.267，P=0.002), increasing conversion rate to thoracotomy (OR=3.123，P=0.004) and increasing postoperative complication rate (OR=1.778，P=0.013). Conclusion Videoassisted thoracoscopic surgery for posterior mediastinal tumor is safe and effective. Maximum diameter of the tumor ≥6 cm is an independent risk factor for increasing operation difficulty and risk.
Objective To assess the medium- and long-term effectiveness of selective posterior rhizotomy (SPR) for spastic cerebral palsy. Methods A retrospective analysis was made on 27 patients with spastic cerebral palsy undergoing SPR between January 1997 and January 2008, whose data were complete with more than 5 years follow-up. There were 14 males and 13 females with an average age of 10.1 years (range, 4-19 years). All patients had simple spastic cerebral palsy, including 17 cases of bilateral spastic palsy and 10 cases of unilateral spastic palsy. The muscle strength, muscle tone, ambulatory function, the sharp foot and crossing-feet, knee jerk, ankle clonus, and Babinski’s sign were evaluated before and after operation. Results All the patients were followed up 5-16 years (mean, 9.6 years). No obvious limitation of lumbar flexion, extension and lateral flexion, spondylolisthesis, kyphosis, and other deformities occurred. At last follow-up, the muscle strength of hip extensors, hip flexors, and knee extensors were significantly increased when compared with preoperative ones (P lt; 0.05); but no significant difference was found in the muscle strength of hip abductors, hip adductors, knee flexors, plantar extensors, and plantar flexors (P gt; 0.05). Abnormal increased muscle tone of hip flexors, hip adductors, knee flexors, and plantar flexors was declined in different degrees in all patients, showing significant differences when compared with preoperative ones (P lt; 0.05); but no significant difference was found in hip extensors, hip abductors, knee extensors, and plantar extensors (P gt; 0.05). At last follow-up, the status of toe steps and crossing-feet disappeared without recurrence for a long time. Sthenic knee jerk was eliminated, but there were several patients also keeping the active knee jerk, showing significant difference when compared with preoperative ones (Z= — 7.404, P=0.000). The results of Babinski’s sign were negative in 31 sides and positive in 13 sides, showing significant difference when compared with preoperative ones (Z= — 6.897, P=0.000). No sharp foot or crossing-feet was observed. And ambulation ability was significantly improved after operation (Z= — 4.111, P=0.000). Conclusion SPR is very effective in decreasing the muscle tone and improving the motor function without recurrence in long-term.
Objective To investigate the medium-term effectiveness of straight tapered rectangular femoral prosthesis in total hip arthroplasty (THA). Methods Between May 2004 and June 2006, 58 cases (61 hips) of hip joint disease underwent THA with straight tapered rectangular femoral prosthesis and the clinical data of 43 cases (45 hips) followed up more than 6 years were retrospectively analyzed. There were 21 males (23 hips) and 22 females (22 hips) with an average age of 51.6 years (range, 25-75 years), including 12 cases (12 hips) of congenital developmental dysplasia of the hip, 1 case (1 hip) of osteoarthritis secondary to acetabular dysplasia, 1 case (1 hip) of hip deformity after poliomyelitis, 9 cases (9 hips) of femoral neck fractures, 8 cases (8 hips) of avascular necrosis of the femoral head, 8 cases (8 hips) of osteoarthritis of the hip joint, 2 cases (3 hips) of rheumatoid arthritis, and 2 cases (3 hips) of ankylosing spondylitis. Unilateral replacement was performed in 41 cases and bilateral replacement in 2 cases. The Harris score was 41.7 ± 10.4 before operation. X-ray examination was performed to analyze the location of femoral prostheses and evaluate the stability of the prosthesis-bone interface, and Harris score was used to evaluate the hip function. Results Periprosthetic fracture occurred in 3 hips, and thigh pain in 4 hips after operation. Forty-three cases (45 hips) were followed up 74-99 months (mean, 85 months). Harris score was 87.6 ± 8.3 at last follow-up, showing significant difference when compared with preoperative score (t=23.14, P=0.00). The X-ray examination showed that 9 hips had heterotopic ossification; bone resorption caused by stress shielding was observed at the proximal femur in 42 hips. But the stability of the prosthesis-bone interface was good; no infection or dislocation occurred; and no revision for aseptic loosening was performed in all cases. The survival rate of the femoral prosthesis was 100% during medium-term follow-up. Conclusion THA with straight tapered rectangular femoral prosthesis has good medium-term effectiveness.
Objective To evaluate the long-term effectiveness of treating early-middle stage avascular necrosis of the femoral head (ANFH) with core decompression and bone grafting. Methods Between January 2000 and December 2006, 87 ANFH patients (114 hips) were treated with core decompression and bone grafting, including 54 cases (62.1%) of alcohol-induced ANFH, 26 cases (29.9%) of steroid-induced ANFH, and 7 cases (8.0%) of idiopathic ANFH. There were 74 males (97 hips) and 13 females (17 hips), aged 20-56 years (mean, 38 years). The disease duration was 3-46 months (mean, 18 months). According to Ficat staging, 16 hips were at stage I, 68 hips at stage II, and 30 hips at stage III. The Harris score and Ficat stage were compared between pre- and post-operation to assess the outcomes clinically and radiologically. The hip survival was analyzed by the Kaplan-Meier method. Results Eighty-seven patients were followed up 5 years to 11 years and 10 months (mean, 8 years and 9 months). The Harris hip score was significantly increased from 73.13 ± 7.17 at preoperation to 81.59 ± 13.23 at postoperation (t= — 9.318, P=0.000). The clinical success rate was 69.3% (79/114) and the radiological success rate was 54.4% (62/114). Kaplan-Meier survival analysis showed that the overall survival rate was 84.2% (96/114); the survival rates of Ficat stage I [100% (16/16)] and stage II [91.2% (62/68)] were higher than that of stage III [60.0%(18/30)] (P lt; 0.01); there was no significant difference between Ficat stage I and II (χ2=1.520, P=0.218). Conclusion Core decompression with bone grafting is a safe and effective procedure for the treatment of Ficat stages I-II (early stage) ANFH, and the long-term effectiveness is satisfactory. But the long-term effectiveness is unsatisfactory for the patients at the Ficat stage III (middle stage).
【Abstract】 Objective To evaluate the mid-term effectiveness of Oxford Unicompartmental Knee system Phase III for medial unicompartmental knee osteoarthritis (OA). Methods Between December 2008 and August 2010, 26 patients (32 knees) with medial unicompartmental knee OA were treated. Of 26 patients, 11 were followed up more than 2 years, including 7 males and 4 females (14 knees, 6 left and 8 right knees) with an average age of 62.4 years (range, 50-74 years). All patients had load suffering and tenderness of medial unicompartmental knee, and complicated by varus deformity without limitation of flexion and extension; the disease duration ranged 5-23 years (mean, 11.6 years). According to Ahlback staging, 4 knees were at stage II and 10 knees at stage III. Cemented unicompartmental knee arthroplasty (Oxford Unicompartmental Knee system Phase III) was performed by minimally invasive technique. Results All the incisions were primary healing after operation. Five cases suffered from local ache in the pes anserinus during the first 3 months after operation, which was cured after conservative therapy. Of them, 11 patients were followed up 27.5 months on average (range, 24-30 months). During follow-up, no complication of prosthesis loosening, displacement, arthropathy in the opposite department, or the patellofemoral joint occurred. The range of motion was significantly improved from (109.2 ± 8.7)° preoperatively to (123.5 ± 6.7)° at last follow-up (P lt; 0.05); knee society score (KSS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores were all significantly improved (P lt; 0.05). At last follow-up, the femoro-tibial angle was significantly improved (P lt; 0.05); tibial plateau and the tibial anatomical axis increased, showing no significant difference (P gt; 0.05); and posterior tibial slope was significantly decreased (P lt; 0.05). Conclusion Oxford Unicompartmental Knee system Phase III has satisfactory mid-term effectiveness in treating medial unicompartmental knee OA with the advantages of little trauma and rapid recovery, but long-term effectiveness is expected for further follow-up.
Objective?To discuss the clinical application of total hip arthroplasty (THA) with collum femoris preserving (CFP) prosthesis and to analyze the mid-term effectiveness.?Methods?Between January 2004 and February 2007, 45 patients (48 hips) underwent THA with CFP prosthesis. There were 29 males (31 hips) and 16 females (17 hips) with an average age of 48.8 years (range, 38-60 years), including 20 left hips, 22 right hips, and 3 bilateral hips. The causes of hip replacement were osteoarthritis (20 cases), avascular necrosis of femoral head (13 cases), dysplasia (4 cases), rheumatoid arthritis (3 cases), post-traumatic osteoarthritis (2 cases), ankylosing spondylitis (2 cases), and Perths disease (1 case). The average disease duration was 6.1 years (range, 2-13 years). Harris scores, visual analogue scale (VAS) score, and the hip range of motion (ROM) were recorded at pre- and post-operation. The X-ray films were taken at pre- and post-operation to observe the position, loosening of the prosthesis, and ectopic ossification. The gait of patients were also evaluated during follow-up. Short-form 36 health survey scale (SF-36) was used to evaluate the life quality of patients.?Results?All 45 patients were followed up 5-8 years with an average of 6.4 years. All the incisions healed by first intention. No infection, hip dislocation, nerve injury, or deep vein thrombosis occurred. Six cleavage fractures (13.3%) of the lateral femoral diaphysis at the distal prosthesis occurred during operation, which healed at 8 months postoperatively without any treatment. Mild ectopic ossification occurred in 4 patients (8.9%) who had no discomfort. Five patients (11.1%) had bone mineral density loss in the region of the proximal femur. The survival rates of the cups and stems were all 100% at last follow-up. The results of Harris score, VAS score, and ROM of the hip joint at 1 year postoperatively and last follow-up were significantly better than preoperative ones (P lt; 0.05). No significant difference was found in VAS score and ROM of the hip joint between at 1 year postoperatively and at last follow-up (P gt; 0.05) except the Harris score (P lt; 0.05). According to Harris functional assessment at last follow-up, the results were excellent in 31 hips, good in 11 hips, and fair in 6 hips with an excellent and good rate of 87.5%. The physiological role, body pain, and total health scores were significantly lower than the reference value of urban men from Sichuan province (P lt; 0.05), but no significant difference was found in the other scores of the SF-36 when compared with the reference value (P gt; 0.05).?Conclusion?THA with CFP prosthesis is a good option for the young patient with complete collum femoris and without osteoporosis, and can achieve good mid-term effectiveness.
Objective To evaluate the mid-term effectiveness of two-stage hip prosthesis revision in the treatment of infection after hip arthroplasty. Methods Between April 2002 and November 2006, 12 cases of infection after hip arthroplasty were treated. There were 5 males and 7 females, aged from 47 to 72 years (mean, 59.8 years). The femoral head arthroplasty wasperformed in 2 cases and total hip arthroplasty in 10 cases. Infection occurred 1 to 67 months after arthroplasty. According to the Segawa classification criteria, infections included type 2 in 1 case, type 3 in 2 cases, and type 4 in 9 cases. The preoperative Harris score was 36.7 ± 6.1. Nine cases had elevated C reactive protein and 10 cases had elevated erythrocyte sedimentation rate. The results of bacterial culture were positive in 8 cases and negative in 4 cases. After the removal of the infected prosthesis and thorough debridement, antibiotic-loaded cement spacers or infected therapeutic temporary prosthesis were used as placeholders, and then the anti-infection treatments were given after operations; two-stage hip prosthesis revisions were performed 3 to 10 months after debridement. Results In 1 patient who failed to control infection after debridement, infection was controlled after the second debridement and the antibiotic-loaded cement spacer as placeholder. Other patients achieved heal ing of incision by first intention, and no compl ication such as deep venous thrombosis and nerve injury occurred. All patients were followed up 3 to 8 years after revision (mean, 5.4 years). During the follow-up, no infection recurrence and joint dislocation occurred. Dull pain was present in 2 cases during activity and mild claudication in 3 cases at last follow-up. The Harris score was 81.6 ± 4.5, showing significant difference (t=52.696, P=0.000) when compared with preoperative score. The X-ray films showed that noprosthesis loosening and obvious subsidence were observed, and bone graft healed. Conclusion The two-stage hip prosthesis revision has good infection control rate and mid-term effectiveness in treatment of infection after hip arthroplasty.
Objective To improve the retrograde rotative-type interlocking intramedullary nail based on humeral bone dissection and cl inical appl ication, and investigate the cl inical values of modified retrograde rotative-type interlocking intramedullary nail for humeral shaft fracture. Methods Between March 2006 and March 2010, 146 patients with humeral shaft fractures were treated and fractures were fixed with the modified retrograde rotative-type interlocking intramedullary nail (the modified group, n=73) and with the retrograde rotative-type interlocking intramedullary nail (the original group, n=73). In the original group, there were 40 males and 33 females with an average age of 41 years; 41 cases were classified as transversefracture, 18 as obl ique fracture, 8 as spiral fracure, and 6 as comminuted fracture; the median disease duration was 11 days (range, 3 hours to 2 months); and close reduction fixation was performed in 27 cases and open reduction fixation in 46 cases. In the modified group, there were 39 males and 34 females with an average age of 40 years; 43 cases were classified as transverse fracture, 16 as obl ique fracture, 10 as spiral fracure, and 4 as comminuted fracture; the median disease duration was 13 days (range, 3 hours to 3 months); and close reduction fixation was performed in 31 cases and open reduction fixation in 42 cases. There was no significant difference in sex, age, fracture type, and disease duration between 2 groups (P gt; 0.05). The fracture heal ing and functional recovery of affected l imbs were compared between 2 groups after operation. Results The operation time and intraoperative blood loss in the modified group were significantly less than those in the original group (P lt; 0.05). Iatrogenic fracture occurred in 3 cases of the original group, which were cleavage fracture of supracondylar. No iatrogenic fracture occurred in the modified group. All incisions of 2 groups healed by first intention without compl ications of postoperative infections, metal fracture, and loosening of internal fixation, etc. A total of 116 patients were followed up more than 12 months in 2 groups with 58 patients in each group. The fracture heal ing time was (15 ± 3) weeks (fresh fracture) and (30 ± 12) weeks (old fracture and nonunion) in the modified group, and was (16 ± 4) weeks (fresh fracture) and (35 ± 14) weeks (old fracture) in the original group, showing significant differences between 2 groups (P lt; 0.05). The results of Neer shoulder score were excellent in 65 cases and good in 8 cases, and the results of Aitken and Rorabeck elbow function score were excellent in 61 cases and good in 12 casesin the original group; the results of Neer shoulder score were excellent in 67 cases and good in 6 cases, and the results of Aitken and Rorabeck elbow function score were excellent in 63 cases and good in 10 cases; and the excellent and good rates were 100% in 2 groups. Conclusion The modified retrograde rotative-type interlocking intramedullary nail has the advantages of easy operation and less compl ication, which is an effective and rel iable internal fixator.
Objective To investigate the surgical technique and short-term effectiveness of anterior cruciate l igament (ACL) reconstruction with LARS artificial l igament. Methods Between November 2008 and April 2010, eighty patients withACL injury were treated with LARS artificial l igament under arthroscope and successfully followed up. There were 51 males and 29 females, aged from 17 to 43 years with an average of 29.2 years. The injuries were caused by sport in 63 cases, traffic accident in 14 cases, and bruise in 3 cases. There were 43 left knees and 37 right knees. The disease duration ranged from 10 days to 11 months. The anterior drawer test, Lachman test, and pivot shift test for all cases were rated as positive. The preoperative Lysholm score was 55.4 ± 5.7, Irgang score was 48.3 ± 6.2, and Larson score was 54.8 ± 7.4; and the International Knee Documentation Committee (IKDC) score was lower than normal level in all cases. Obl ique coronal MRI showed ACL injury in all cases. Residual ACL and synovium were preserved during surgery. Results All incisions healed by first intention without compl ication of infection or deep venous thrombosis. All patients were followed up 7 to 24 months with an average of 16.8 months. There were 3 cases of screws exposure toward femoral cortical bone, 2 cases of loosening tibial screw, and 1 case of knee extension l imitation, and they were cured after symptomatic treatment. No LARS artificial l igament rupture and joint fibrosis occurred during followup. At last follow-up, the results of anterior drawer test, Lachman test, and pivot shift test were positive in 2, 3, and 3 patients,respectively. There were significant differences in Lysholm, Irgang, and Larson scores of affected knees between preoperation and 6 weeks postoperatively, last follow-up, respectively (P lt; 0.05). The normal rate of IKDC score were 43.75% (35/80) and 97.50% (78/80) at 6 weeks postoperatively and last follow-up, respectively. Conclusion The viscoelastic properties of LARS artificial l igament is different from that of biological materials. The graft should be fixed at a relatively extension position to avoid knee extension l imitation and sl ight loosening of graft tension is permitted at flexion position. Good cl inical result could be achieved if the technique is well appl ied.