Objective To investigate the cl inical therapeutic results of allograft tendon for anatomical reconstruction of medial patellofemoral l igament (MPFL) in patellar dislocations. Methods From September 2005 to June 2008, 20 patientswith patellar dislocation underwent MPFL reconstructions. There were 4 males and 16 females, aged 13 to 31 years (19 years on average). Patellar dislocations occurred in 7 left and 13 right knees, including 6 cases of acute dislocation and 14 cases of recurrent dislocation. The disease course was 1 day to 2 years. The frequency of dislocation was 1-6 (4 on average). Affected knee joint showed pain, swell ing and patellar instabil ity; the range of action for patella obviously increased. The X-ray films showed patellar dislocation or medial margin avulsion fracture. The preoperative Q angle was (15 ± 3)°, the congruence angle was (10 ± 11)°. Reconstruction was performed via allograft tendon. Allograft tendon was anchored to the superomedial pole of the patella by two bone anchors, and the other end was fixed at the natural MPFL insertion site near the medial femoral condyle with an interference screw in a bone tunnel. All patients were evaluated postoperatively; Kujala patellofemoral scores, objective knee function, compl ications, and reoperations were assessed. Results Primary heal ing was achieved in 18 cases and secondary heal ing in 2 cases. No infection or necrosis and absorption of grafts was observed. All patients were followed up for an average of 25.6 months (range, 6-34 months) postoperatively. At last follow-up, other patients had no pain, swell ing and patellar instabil ity except 1 case; neither patella redislocation nor fracture occurred. The X-ray films showed good position of anchors and tunnel 6 months after operation, and the congruence angle was (3 ± 8)°, showed statistically significant difference when compared with preoperation (P lt; 0.05). The postoperative Q angle was (15 ± 2)°, the Kujala knee function score improvedsignificantly from 60.8 ± 7.2 to 83.4 ± 8.0 at last follow-up, showing statistically significant difference (P lt; 0.05). According to Insall et al. for function, the results were excellent in 12 cases, good in 6 cases, and fair in 2 cases, the excellent and good rate was 90%. Conclusion MPFL reconstruction improves cl inical symptoms. Anatomical MPFL reconstruction is effective for patellar dislocation, and it offer good recovery of the pre-morbid patella mechanics. There would be l ittle bone loss when tendon is fixed by anchors, and there would be less patellar fracture than bone tunnel technique. The bone anchors also provide firm fixation. Allograft can avoid the graft harvest site morbidity, but it increases the cost of the surgery.
Objective To investigate the effectiveness of arthroscopic anterior cruciate ligament (ACL) reconstruction via transtibial (TT) and transportal (TP) techniques after 10 years follow-up. Methods A clinical data of 103 patients who underwent arthroscopic ACL reconstruction with a single bundle of autologous hamstring tendon between March 2006 and March 2009 was retrospectively analyzed, among which 57 patients were reconstructed with TT technique (TT group) and 46 patients were reconstructed with TP technique (TP group). There was no significant difference in gender, age, cause of injury, interval between injury and operation, preoperative pivot shift test, preoperative International Knee Documentation Committee (IKDC) score, Lysholm score, and KT-2000 side-to-side difference (SSD) between the two groups (P>0.05). At 10 years after operation, Lachman test was used to evaluate the forward joint stability and pivot shift test to evaluate the rotational stability of the knee; KT-2000 SSD was used to measure tibial anterior displacement; IKDC score and Lysholm score were used to evaluate knee function; MRI examination was performed to observe graft healing and measure coronal inclination angles of the tibia and femoral tunnels. The rate of return to sports was also calculated. Results The incisions healed by first intention in the two groups, and no early complication occurred after operation. All patients were followed up 10-13 years, with an average of 11.5 years. During the follow-up period, there was no limitation of knee extension and flexion, no discomfort of donor site or graft failure in either group. MRI examination showed that the graft healed well. The IKDC score, Lysholm score, and KT-2000 SSD in the two groups were significantly improved after 10 years (P<0.05), and there was no significant difference between the two groups at 10 years after operation (P>0.05). There were significant differences in coronal inclination angles of femoral tunnel and tibial tunnel between the two groups (P<0.05). There was no significant difference in Lachman test and pivot shift test between the two groups (P>0.05). The rate of return to sports of patients was 61.40% (35/57) in TT group and 63.04% (29/46) in TP group, showing no significant difference between the two groups (χ2=0.29, P=0.87). Conclusion TT and TP techniques can both achieve good effectiveness in ACL reconstruction.
With the rapid development of the field of interventional therapy of cardiac valve, the innovative researches of interventional therapy of cardiac valve products have become the focus of global research. At present, there is a serious shortage of interventional valvular medical devices on the market in China, and large-scale interventional valve products are undergoing early human trials or confirmatory clinical trials. The effective quality control of clinical trials is of great significance to ensure that clinical trial data can be used to support the marketing of device products. By analyzing the problems in clinical trials quality control of interventional valvular medical devices in our hospital, and combining the characteristics of device products and diseases, we explore the key points of quality control and provide reference for the implementation and completion of high-quality clinical trials.