Objective:To explore and think about the project management model of investigator-initiated trial (IIT), and the project management of industry sponsored trial (IST), we should standardize the management process of clinical research projects initiated by researchers, improve the management system of clinical research in medical institutions, improve the quality management level of clinical research, and protect the rights and interests of research participants.Methods:By taking the clinical research management of a medical and health institution in Hainan province as an example, one of the first pilot areas for the standardized management of clinical research by the National Health Commission, the difficulties in the management of clinical research initiated by researchers were sorted out, to analyze and standardize the management of clinical research project initiated by researchers.Results:Discussion Project management was the primary link and basic guarantee of standardized management of clinical research, and scientific and feasible project management was a powerful hand to carry out deep and high-quality IIT.Conclusions:It can be manifested in a Hainan provincial public medical institution that a feasible project management was the basement in carrying out the profound and high quality IIT. It is advicable to make full use of policy advantages and clinical resources to produce high-quality research results as well as build a high-level research hospital.

Bone defects caused by different causes such as trauma, severe bone infection and other factors are common in clinic and difficult to treat. Usually, bone substitutes are required for repair. Current bone grafting materials used clinically include autologous bones, allogeneic bones, xenografts, and synthetic materials, etc. Other than autologous bones, the major hurdles of rest bone grafts have various degrees of poor biological activity and lack of active ingredients to provide osteogenic impetus. Bone marrow contains various components such as stem cells and bioactive factors, which are contributive to osteogenesis. In response, the technique of bone marrow enrichment, based on the efficient utilization of components within bone marrow, has been risen, aiming to extract osteogenic cells and factors from bone marrow of patients and incorporate them into 3D scaffolds for fabricating bone grafts with high osteoinductivity. However, the scientific guidance and application specification are lacked with regard to the clinical scope, approach, safety and effectiveness. In this context, under the organization of Chinese Orthopedic Association, the Expert consensus for the clinical application of autologous bone marrow enrichment technique for bone repair ( version 2023) is formulated based on the evidence-based medicine. The consensus covers the topics of the characteristics, range of application, safety and application notes of the technique of autologous bone marrow enrichment and proposes corresponding recommendations, hoping to provide better guidance for clinical practice of the technique.

【Objective】 To investigate the quality of cryoprecipitates prepared from buffy coat-derived plasma of fresh whole blood at room temperature 20℃-24℃ isolated at different time periods, explore the optimal time for preparing cryoprecipitates, so as to improve the utilization rate of blood. 【Methods】 A total of 250 bags of whole blood collected by CPDA-1 and stored at 20℃-24℃ from October 2020 to December 2020 were randomly selected as the experimental group, and divided into groups A1 (0-8 h), A2 (8-10 h), A3 (10-12 h), A4 (12-14 h) and A5 (14-16 h) (with 50 bags in each group) according to the preparation time point. The upper-buff-coat plasma was separated and quickly frozen as the source for cryoprecipitates. Meanwhile, another 50 bags of fresh frozen plasma prepared within 0-16h after routine storage at 2℃-6℃ were randomly selected as the control group (group B), which was used as the raw plasma to make cryoprecipitate. Coagulation factor Ⅷ (Ⅷ factor) and fibrinogen (FIB) were detected, and the effect of different preparation time and different storage temperature on the content of factor Ⅷ and FIB and the pass rate were compared. 【Results】 In comparison to the control group, the Ⅷ factor content of groups A4 and A5 was significantly decreased, and the differences between groups A4, A5 and B were statistically significant (P<0.001). There was no statistically significant difference in the effect of preparation of buffy coat-derived plasma on the FIB quality of cryoprecipitate in different time periods (P>0.05). The Factor Ⅷ content ≥60 IU/ bag prepared from buffy coat-derived plasma accounted for 96.4% (1.5 U) in the experimental group. 【Conclusion】 The buffy coat-derived plasma prepared within 12 h at 20℃-24℃ is suitable for preparing 2 U cryoprecipitate coagulation factor, while that prepared within 12-16 h is suitable for preparing 1.5 U cryoprecipitate coagulation factor.

ObjectiveTo evaluate the efficacy and safety of a perioperative rehabilitation clinical pathway of acetabular fracture in light of orthopedics rehabilitation team approach. MethodsA prospective randomized control trial was conducted in 82 patients with acetabular fractures who had been admitted from the Emergency Department of Orthopaedic Trauma, Beijing Jishuitan Hospital from June, 2019 to January, 2021. The patients were randomly divided into control group (n = 41) and intervention group (n = 41). The control group was managed routinely, while the intervention group received the rehabilitation clinical pathway, for 24 weeks. The Visual Analogue Score (VAS) of pain, the Barthel Index (BI) and Majeed Pelvic Score were compared. ResultsFinally, 76 patients completed the trial. There was no statistical difference in VAS score between two groups in all periods (|Z| < 1.926, P > 0.05). The BI score was higher in the intervention group than in the control group at discharge, two weeks, six weeks and twelve weeks after operation (|Z| > 2.121, P < 0.05); and no significant difference was found before operation and 24 weeks after operation (|Z| < 1.862, P > 0.05). Majeed Pelvic Score was higher in the intervention group than in the control group two weeks, six weeks, twelve weeks and 24 weeks after operation (|Z| > 2.428, P < 0.05). Six, twelve and 24 weeks after operation, the excellent rate of Majeed Pelvic Score was higher in the intervention group than in the control group (χ² > 6.136, P < 0.05). ConclusionIn comparison with traditional protocol in acetabular fracture, the perioperative rehabilitation clinical pathway was proved effective and of great safety in the light of the integration of orthopedics and rehabilitation mode for improving the function and activities of daily living of patients.

Objective:To explore the feasibility and therapeutic efficacy of using the Henry approach to expose and place a metaphyseal bone plate laterally to fixate a proximal radial shaft fracture.Methods:A retrospective analysis was done of the 5 proximal radial shaft fractures (defined as the fracture involving the extent between the radial tuberosity to the insertion of the pronator teres) which had been treated from April 2018 to June 2019 at Department of Traumatology and Orthopedics, Beijing Jishuitan Hospital through the Henry approach to place a metaphyseal plate laterally to the radius for fixation. There were 2 males and 3 females, aged from 16 to 59 years (average, 41.4 years), with 3 cases on the left side and 2 cases on the right side. The imaging data, fracture healing time, forearm pronation-supination, and visual analogue scale (VAS) of the patients were regularly followed up; the therapeutic efficacy was evaluated at the last follow-up using Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH), Anderson and Grace-Eversmann evaluations.Results:The 5 patients were followed up for 7 to 16 months (average, 10.6 months). Their fracture healing time averaged 4.6 months, elbow flexion 146°, extension -2°, pronation 77°, and supination 88°. In postoperative VAS, 4 cases scored a 0 point and one case 1 point. At the last follow-up, their Quick-DASH scores averaged 4.1 points; by the Anderson evaluation, 5 cases were excellent; by the Grace-Eversmann evaluation, 4 cases were excellent and one case was good. No postoperative complication was observed.Conclusion:It is an effective treatment of proximal radial shaft fracture to use the Henry approach to expose and place a 3.5mm metaphyseal plate laterally to the radius for fixation.

【Objective】 To evaluate the quality of platelet concentrates prepared by two different blood collection bags, so as to provide references for the development of high-quality platelet preparation. 【Methods】 Platelet concentrates were prepared using buffy coating from the whole blood collected by conventional and optimized single-use blood collection bags with leukoreduction filter, respectively. The volume of whole blood collected was 400 mL, and 60 bags in total. They were divided into group A (conventional collection bags, n=30), and the size of buffy coating pouch was 15 cm×12 cm; group B (optimized collection bags, n=30), and the size of buffy coating pouch was 11 cm×9 cm. 【Results】 There were significant differences between group A and group B in the amount of red blood cells contamination, platelet content, and platelet yielding rate (P<0.05), which were (2.62±0.57)×10⁹/mL vs (1.37±0.35)×10⁹/mL, (4.41±0.31)×10¹⁰/mL vs (6.21±0.63)×10¹⁰/mL, and (55.03±0.06)% vs (79.23±0.09)%, respectively. 【Conclusion】 The buffy coating pouch with the size of 11 cm×9 cm can produce better platelet concentrates, thus improves the safety and efficacy of clinical blood transfusion.

Objective To introduce the technique we invented to treat hypertrophic and oligotrophic nonunion of femoral shaft fracture after dynamization of intramedullary nail (IMN) and to report its preliminary results.Methods The data of 2 cases with hypertrophic nonunions of femoral shaft fracture and 1 case with oligotrophic nonunion following IMN dynamization who had been treated by the technique from March 2006 to July 2017 in Beijing Jishuitan hospital were retrospectively studied.There were 2 females and 1 male,aged 50,66 and 24 years old.2 parallel half pins were inserted from anterior to posterior at the trochanteric and condylar zones of the femur for antegrade intramedullary nailing patients,and from lateral to medial sides for retrograde intramedullary nailing patient respectively,then the pins were connected with monolateral limb reconstruction fixator.The fracture nonunion site was compressed by the fixator up to 10-15 mm.The holes at the end of intramedullary nail where their screws were removed for dynamization were locked again with 2 locking screws,and then the frame was removed.The patients are allowed to start their rehabilitation and fully bear their body weight 1 day after the operation.Results The three patients were followed up for 25,22,and 7 months after the surgery,respectively.The X-ray films showed the fracture healed at 7 months in two case,and at 12 months in one.One patient got her nail removed 25 months after the operation,feeling good 37 months after the removal.Conclusion This technique is an option to manage the hypertrophic and oligotrophic fracture nonunion of the femur after dynamization of IMN.It is mini-invasive to the nonunion site,easy to practice and allows early rehabilitation.

Objective: To discuss the result of treating tibia deformity with fixator assisted nailing technique (FAN). Methods: A total of 5 patients with 7 limbs of tibial deformity-were treated with FAN technique. Etiology: 2 patients with bilateral tibial deformity suffered from Ricket's disease, 2 patients were malunion after tibial fracture, 1 patient was congenital pseudoarthrosis of tibia. This is a retrospective study. The unilateral external fixator was mounted on the medial side of tibia, and thenthe minimal invasive osteotomy was performed. After the deformity was corrected, the intramedullary nail was inserted to fix the tibia. None of the patients need bone autograft. The pre-operation and post-operation medial proximal tibia angle (MPTA), mechanical axis deviation (MAD) and range of motion (ROM) were measured and analyzed. Results: All the 5 patients were followed-up for 12-60 months (average 32 months). The osteotomy site united in 3-5 months (average 4.5 months) post-operatively. According to Paley’s imaging scores, 4 patients were excellent and 1 patient was good. According to Paley's functional result scores, 5 patients were excellent; according to Paley’s bone results evaluation, 4 patients were excellent and 1 patient was good. We achieved desired post-operative MAD (from medial 15 mm-lateral 10 mm) in 6 limbs. The MPTA in 7 limbs was corrected to normal (84°-90°). The ROM was not significantly changed before and after operation. The average ROM of knee before operation was 125°(120°-135°), and average postoperative ROM was 120°(115°-130°), No deep infection or neurovascular injury occurred. All patients were satisfied with the method and results of the operation. Conclusion FAN technique combines the advantage of external fixation and intramedullary nail, and it is a good method to treat tibial deformity, the patient should be carefully evaluated and selected for applying this technique.

Objective To evaluate the medial submuscular plating of the femur after limb lengthening and correction with frame in patients with limb length discrepancy and/or angular deformity.Methods A retrospective study was conducted involving 12 patients who had been referred to Department of Orthopaedic Trauma,Beijing Jishuitan Hospital from December 2009 to November 2016 for limb length discrepancy and/or angular deformity.They were 3 males and 9 females,with an average age of 23 years (from 14 to 32 years).Altogether 4 left and 8 right sides were involved.Of them,11 got their length discrepancy and/or angular deformity secondary to injury to distal femoral epiphyseal plate caused by trauma in their childhood and one had length discrepancy and angular deformity following unsuccessful conservative treatment of superior condylar fracture of the femur.The femoral shortening ranged from 3 to 11 cm (average,6.7 cm),and the varus or valgus deformity of the knee ranged from 8° to 18° (average,12°).First,a monolateral fixator was installed on the lateral femur.The limb was lengthened from 7 to 14 days after diaphysis osteotomy.Femoral supracondylar osteotomy was conducted again in patients with knee angular deformity after the lengthening reached the expected length and the deformity was corrected with the aid of external fixator.After medial submuscular plating via the femoral lateral approach using minimally invasive techniques,the external frames were removed.The time for plate removal,limb lengthening and correction of the varus or valgus deformity were documented.Results The mean follow-up was 31 months (from 23 to 43 months) for the 9 patients who had their plates still in situ,and 6.5 months (from 2 to 14 months) for the 3 patients who had subsequently their plates removed.None had blood transfusion.All underwent distraction osteogenesis of the femur to their preoperatively expected length,ranging from 3 to 9 cm (mean,6.2 cm).Both varus and valgus deformities were corrected.None developed a deep infection.The range of motion of the knee joint was similar to that before operation in all but one patient who had a range of motion 40° less than the pre-operative one.The time for external fixation averaged 91 days (from 46 to 113 days),with an external index of 22 d/cm.All patients were satisfied with their outcomes.Conclusion Medial femoral submuscular plating after limb lengthening and angular deformity correction with the external fixator on the lateral side is a useful technique for patients with femoral limb length discrepancy and/or angular deformity,significantly shortening the time for external fixation.

In numerous digestive reconstruction techniques after proximal gastrectomy for tumor of the gastroesophageal junction,widely used methods are esophagogastrostomy,esophagogastric tube reconstruction and jejunalinterposition reconstruction.More studies have been focused on jejunalinterposition reconstruction in recent years,from which a variety of modified reconstructions derive.In clinical practice,a flexible choice is needed according to the actual situation of patients.