|Year : 2019 | Volume
| Issue : 1 | Page : 8-16
Efficacy and safety of proximal femoral anatomical locking compression plate and proximal femoral nail antirotation for long-segment comminuted subtrochanteric fractures of the femur: a non-randomized controlled trial
Jie-Rong Zhang1, Shi-Xi Xiong1, Xiao-Lin Tian1, Fang-Mao Gao1, Chao Lin1, Li-Xue Yang2
1 Department of Orthopedics, Sanya Traditional Chinese Medicine Hospital, Sanya, Hainan Province, China
2 Department of Orthopedics, First Affiliated Hospital, Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China
|Date of Submission||05-Dec-2018|
|Date of Acceptance||21-Jan-2019|
|Date of Web Publication||13-Mar-2019|
Department of Orthopedics, Sanya Traditional Chinese Medicine Hospital, Sanya, Hainan Province
Source of Support: None, Conflict of Interest: None
Background and objective: The proximal femoral anatomical locking compression plate and proximal femoral nail antirotation device are commonly used in the treatment of long-segment comminuted subtrochanteric fractures of the femur. However, few studies have evaluated the difference in efficacy and safety between these two implants. The present study is being performed to compare the efficacy and safety of the proximal femoral anatomical locking compression plate versus proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur. The results will be used to identify the optimal implant treatment plan.
Participants and methods: This prospective, single-center, non-randomized controlled clinical trial will include 180 patients with long-segment comminuted subtrochanteric fractures of the femur from Sanya Traditional Chinese Medicine Hospital, China. The patients will be equally divided into a locking compression plate group and a proximal femoral nail antirotation group. All patients will be followed up at 2 and 10 months postoperatively. Patient recruitment and data collection will begin on June 30, 2019 and end on June 30, 2020. Analysis of the results will be performed from 1 to 30 July 2020. This study will be scheduled to end on August 1, 2022. This study was approved by the Medical Ethics Committee of Sanya Traditional Chinese Medicine Hospital in China in March 2013 (approval No. (2013) (02)). Study protocol version is 1.0. This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants.
Results: The primary outcome measure is the rate of excellent and good Harris hip scores at 10 months postoperatively; this rate will be used to evaluate the recovery of hip function after repair. The secondary outcome measures are the rate of excellent and good Harris hip scores preoperatively and 2 months postoperatively, intraoperative blood loss, operation time, incision length, hospital stay, fracture healing time, hip morphology on radiographs preoperatively and 2 months postoperatively, and incidence of adverse events 2 and 10 months postoperatively. Our pilot study involved 80 patients with long-segment comminuted subtrochanteric fractures of the femur from February 2013 to February 2016 (locking compression plate group, n = 40; proximal femoral nail antirotation group, n = 40). The 10-month follow-up results showed that the intraoperative blood loss, operation time, incision length, hospital stay, and fracture healing time were lower in the proximal femoral nail antirotation group than in the locking compression plate group (P < 0.05). The rate of an excellent and good Harris hip score was higher in the proximal femoral nail antirotation group than in the locking compression plate group (P < 0.05). The complication rate was lower in the proximal femoral nail antirotation group (10.0%) than in the locking compression plate group (12.5%) (P > 0.05). These pilot study results verified higher efficacy and safety of proximal femoral nail antirotation than locking compression plate fixation in the treatment of long-segment comminuted subtrochanteric fractures of the femur.
Conclusion: The results of the present study will provide evidence indicating whether proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur can facilitate better recovery of hip function and higher safety than anatomical locking compression plate fixation.
Trial registration: This study was registered with the Chinese Clinical Trial Registry on February 3, 2019 (registration number: ChiCTR1900021251).
Keywords: long-segment comminuted subtrochanteric fractures of the femur; anatomical locking compression plate; proximal femoral nail antirotation; proximal femur; internal fixation; intraoperative blood loss; fracture healing; Harris hip score; X-ray; non-randomized controlled trial
|How to cite this article:|
Zhang JR, Xiong SX, Tian XL, Gao FM, Lin C, Yang LX. Efficacy and safety of proximal femoral anatomical locking compression plate and proximal femoral nail antirotation for long-segment comminuted subtrochanteric fractures of the femur: a non-randomized controlled trial. Clin Trials Orthop Disord 2019;4:8-16
|How to cite this URL:|
Zhang JR, Xiong SX, Tian XL, Gao FM, Lin C, Yang LX. Efficacy and safety of proximal femoral anatomical locking compression plate and proximal femoral nail antirotation for long-segment comminuted subtrochanteric fractures of the femur: a non-randomized controlled trial. Clin Trials Orthop Disord [serial online] 2019 [cited 2019 Mar 19];4:8-16. Available from: http://www.clinicalto.com/text.asp?2019/4/1/8/253724
| Introduction|| |
Long-segment comminuted subtrochanteric fracture of the femur is a common fracture of the hip joint encountered in the clinical setting. Its anatomical structure is special and its treatment is relatively difficult.,,,, Conservative treatment is commonly performed, but adverse events such as deep vein thrombosis and pulmonary infection readily occur. The proximal femoral anatomical locking compression plate (LCP) and proximal femoral nail antirotation (PFNA) are commonly used devices in the treatment of long-segment comminuted subtrochanteric fractures of the femur.,,, The PFNA has the advantages of effective biomechanics and good fixation,, can minimize damage to the blood supply around the fracture, and is conducive to early rehabilitation; however, iatrogenic fractures easily occur during the operation. The LCP is a minimally invasive plate that has strong anti-rotation ability, can be fixed without plasticity, and is conducive to fracture healing; however, it has high technical requirements.,, Few studies have compared the efficacy and safety between these two therapeutic methods in the treatment of long-segment comminuted subtrochanteric fractures of the femur.
The first author performed an online search of the PubMed database for papers published from January 2015 to December 2017 using the search terms “proximal femoral locking compression plate,” “proximal femoral nail antirotation, ” “femoral trochanteric,” and “fracture.” The three most recent studies,, regarding the repair of femoral fractures using different implants were screened [Table 1].
|Table 1: Three most representative studies regarding the repair of femoral fractures using different implants published during 2015–2017|
Click here to view
This trial will compare the efficacy and safety of the LCP and PFNA in the treatment of long-segment comminuted subtrochanteric fractures of the femur.
| Participants and Methods|| |
Prospective, single-center, non-randomized controlled clinical trial.
Sanya Traditional Chinese Medicine Hospital, Sanya, Hainan Province, China.
All surgeons who will be performing surgery, imaging examination, and hip function evaluation in this study have received professional medical training and have more than 5 years of clinical experience.
The study protocol and the content of the recruitment advertisement were approved before publication of the recruitment information. Recruitment notices will be posted on the bulletin board of Sanya Traditional Chinese Medicine Hospital. Interested patients and their family members, all of whom will know the purpose and conditions of this trial, will contact the principal investigator via telephone and will submit their names and telephone numbers.
After contacting the applicant (patient) in clinical trial, the staff members will initially assign patients into groups according to the requirements of the clinical trial. Based on the principle of voluntary patient participation, informed notification and group screening (qualification description) will be carried out according to statutory requirements and procedures.
All patients will be included according to the eligibility criteria and after providing written informed consent.
The patients will receive the latest treatment information during the course of their participation in the clinical trial. They will simultaneously be followed up by the professional medical team of our hospital. The imaging examination fee and registration fee will be waived during follow-up.
Inclusion criteria determined by experts participating in this study
- Diagnosis of long-segment comminuted subtrochanteric fractures of the femur as confirmed by imaging examination and in accordance with the relevant diagnostic criteria in Practical Orthopaedics
- Fresh and closed fracture at admission and performance of preoperative traction under the tibial tubercle of the affected extremity or supracondylar bone of the femur for 4 to 11 days
- Extension of fracture line 5 to 20 cm distal to the lesser trochanter but not to the femoral trochanter
- Provision of written informed consent
Exclusion criteria determined by experts participating in this study
- Old or pathological intertrochanteric femoral fracture
- Surgical contraindication
- Poor compliance or unable to cooperate with treatment
- Combined fracture of the femoral head or other parts of the lower extremities
Provision of insurance
During treatment in our hospital, the patient will be definitively diagnosed with a disease or determined to require an operation specified in the special medical insurance contract. The medical insurance company will pay for the patient's treatment and nursing expenses according to the amount agreed upon in the contract.
Implant information is shown in [Table 2].
All patients will be treated with bone traction. Conventional treatment for swelling at the fracture site will also be performed. The fracture site will be examined by imaging to assess the reduction. The traction weight will be flexibly adjusted according to the patient's condition to maintain the normal length of the affected limb. A detailed surgical plan will be formulated in accordance with the results of the preoperative examination, and suitable implants will be selected according to the fracture condition. Antibiotics will be used once before the operation, and homologous suspended erythrocytes will be used when necessary.
Repair with anatomical LCP
The patient will be placed in the prone position, and spinal-epidural anesthesia will be induced. To facilitate X-ray fluoroscopy of the affected limb during the operation, the healthy limb will be placed in the knee flexion position. [Figure 1] shows the procedures for repair with the LCP.
|Figure 1: Flow chart of repair using anatomical locking compression plate|
Click here to view
Repair with PFNA
Anesthesia and reduction will be the same as those in the LCP group. Under X-ray fluoroscopy, the reduction at the fracture end will be assessed. If it is not satisfactory, a small incision will be made during the operation and the reduction will be performed again. After determining the position of the greater trochanter of the femur, the skin will be cut layer by layer. The gluteus medius will be longitudinally and bluntly separated. The apex of the greater trochanter of the femur will be identified, and a hole will be made at one-third of the trochanter. [Figure 2] shows the procedures for repair with PFNA.
Routine examinations will be performed before the operation, and basic diseases such as diabetes mellitus and osteoporosis will be actively controlled. Operations will be carried out with the help of a traction bed to the greatest extent possible. This can not only shorten the operation time but can also help to reduce complications during the operation. To avoid iatrogenic fracture, the main nail will be inserted with gentle force. Accurate positioning of the needle insertion points can avoid femoral neck fracture or trochanteric splitting fracture caused by internal or external deviation, thereby aggravating fracture displacement.
The patients' vital signs will be closely monitored after the operation. Imaging examinations will be performed regularly. The drainage tubes will be removed according to the patients' recovery conditions.
Primary outcome measure
Rate of excellent and good Harris hip scores at 10 months postoperatively: The recovery of hip function in each group will be judged by the Harris hip score, which includes assessment of pain, living ability, and activity range for a total score of 100. The excellent, good, average, and poor values are ≥ 90, < 90 to ≥ 80, < 80 to ≥ 70, and < 70 scores, respectively. The following formula will be used: Rate of excellent and good Harris hip scores = (number of patients with excellent and good Harris hip scores / total number of patients) × 100%.
Secondary outcome measures
- Rate of excellent and good Harris hip scores before surgery and 2 months after surgery: The evaluation criteria are the same as above.
- Intraoperative blood loss: A lower amount of bleeding during the operation is associated with a more effective repair method and a safer operation.
- Operation time: A shorter operation time is associated with a more effective repair method.
- Incision length: A smaller incision length is associated with less surgical trauma caused by the repair method.
- Hospital stay: A shorter hospital stay is associated with better patient recovery.
- Fracture healing time: The time from fracture repair to complete healing.
- Hip morphology observed using X-ray before surgery and 2 months after surgery: Anteroposterior and lateral X-ray films of the hip joint will be taken to observe the fracture healing in different follow-up periods. The Karlström and Olerud criteria for evaluating the efficacy of femoral fractures will be used: no pain in the thighs, normal walking ability, and no angulation, rotation or shortening deformity; X-ray shows a blurred fracture line and a continuous callus passing through the fracture line; or intermittent, slight pain with unlimited walking, angular rotation deformity of < 10°, and lower limb shortening of < 1 cm. Fracture healing will be determined based on these criteria.
- Incidence of adverse events 2 and 10 months after surgery: The following adverse events will be assessed in each group: deep venous thrombosis, nonunion, pulmonary infection, internal fixation rupture, coxa vara, and urinary tract infection. The following formula will be used: Incidence of adverse events = (number of patients with adverse events during follow-up / total number of patients) × 100%.
The schedule for the primary and secondary outcome measures is listed in [Table 3].
According to the pilot-test results and clinical experience, it is hypothesized that the excellent and good rate of Harris hip score in the PFNA and LCP groups will be 90.0% and 72.5%, respectively 10 months after treatment. Assuming β = 0.2, power = 80%, and α = 0.05 (two-sided), a final effective sample size of n = 75 per group was calculated using the PASS 11.0 software (PASS, Kaysville, UT, USA) using Z test with pooled variance. Assuming a patient loss rate of 20%, we will require 90 patients per group.
In total, 180 patients with long-segment comminuted subtrochanteric fractures of the femur will be equally divided into the LCP group and PFNA group, in which LCP and PFNA fixation will be performed, respectively. Randomized grouping and allocation concealment will not be performed.
Double-blind grouping will not be performed. However, the assessors responsible for the Harris hip score will be unaware of the test plan, and the score will be evaluated blindly.
This study was approved by the Medical Ethics Committee of Sanya Traditional Chinese Medicine Hospital in China in March 2013 (approval No. (2013) (02); Additional file 1[Additional file 1]). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Study protocol version is 1.0. This manuscript will be prepared according to Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement (Additional file 2[Additional file 2]).
Patients and their family members will participate in the trial voluntarily. All patients will sign the informed consent on the premise of fully understanding the treatment plan (Additional file 3[Additional file 3]).
Data authenticity management
All data filled in case report forms will be checked by the main researcher for its accuracy and completeness as well as consistency with original records. All corrected or commented mistakes will be signed and dated by the main researchers or authorized personnel.
Epi-Data 3.0 software will be used to establish the corresponding entry procedure based on the items in the case report form. The local review qualification conditions will be designated at the time of entry and an attempt will be made to run the database to establish the database system dedicated to this trial. Data will be input by data manager using the double entry method. Data will be checked for accuracy.
Data quality control
The Independent Data Monitoring Committee will include an orthopedic specialist, medical statistician, clinical trial manager, and ethicist.
Follow-up information will provide the data supervisors with the following opportunities: to assess the research progress; to verify the accuracy and completeness of the case reports; to ensure that all programs, applicable laws and/or regulations, and investigator obligations are met; and to address inconsistencies in any research record.
Modification of research plan
Other participating researchers may not modify the content of the protocol (such as the inclusion criteria, outcome measures, and data analysis) without the permission of the research leader during the trial.
The clinical inspector will carry out the clinical quality inspection by regularly visiting the experimental unit or according to the actual situation of the trial. The Independent Data Monitoring Committee will report the progress of the trial to the Ethics Committee every 2 months.
Researchers will confirm and support the principle that patients have the right to protect their privacy from invasion. During the trial and data analysis, all data will be identified only by the patients' identification number and initials. Patients' personal information will be kept strictly confidential.
All data will be statistically analyzed using SPSS 22.0 software (IBM Corp., Armonk, NY, USA). In the statistical analysis, the number of cases completed in each research center and the drop-out rate will first be examined. Next, the demographics of the two groups of patients and the relevant baseline characteristics will be analyzed to assess the comparability between the LCP and PFNA groups. Measurement data will be expressed as mean; standard deviation; median, minimum, and maximum values; and upper and lower quartiles. Count data will be expressed as number and percentage.
The two-sample t-test (normally distributed data) or Mann–Whitney U test (non-normally distributed data) will be used to compare the intraoperative blood loss, operation time, incision length, hospital stay, and fracture healing time at each time point between the LCP and PFNA groups. Repeated-measures analysis of variance and the least significant difference test will be utilized to compare the above-mentioned indices in each group among different time points. Pearson's chi-square test will be applied to compare the rate of excellent and good Harris hip scores and the incidence of adverse events between the LCP and PFNA groups. The significance level (two-sided) will be α = 0.05.
All included patients will be assigned to the per-protocol set, which is the set of patients who complete the study without major protocol deviations and with tight enough compliance.
| Results|| |
Patient flow chart
The flow chart of the experimental intervention is shown in [Figure 3].
Patients intended to be recruited into the trial
According to the previously reported admission of patients with long-segment comminuted subtrochanteric fractures of the femur (approximately 100 cases per year), it is predicted that approximately 200 patients will be recruited from June 30, 2019 to June 30, 2020.
Baseline requirements for prospective recruits
The patient baseline data, including age, sex, injury side, cause of injury, and fracture classification, will be recorded in detail before surgery.
Expected outcome measures
The intraoperative blood loss as an intraoperative indicator, Harris hip score, hospital stay, fracture healing time, X-ray results, and adverse events will also be recorded in detail.
Expected possible adverse events
All adverse events in the trial will be allowed to be recorded only once, and only the first adverse event will be counted. In the event of serious adverse events (such as myocardial infarction, cerebral infarction, shock, and re-fracture due to other factors), the clinician will report to the project manager and the leader of the office of the drug clinical trial institution within 2 hours. The office of the drug clinical trial institution will report to the Provincial Food and Drug Administration, Ethics Committee, and Sponsor within 24 hours. The clinical research doctor will perform treatment according to the patient's condition and, if necessary, initiate a precaution to prevent and treat the patients and emergencies in the medical treatment. The main adverse events observed in the trial will be deep vein thrombosis, urinary system infection, and pulmonary infection.
Small-sample-size pilot study results
Our pilot study involved 80 patients with long-segment comminuted subtrochanteric fractures of the femur from February 2013 to February 2016. All patients were equally and randomly divided into the LCP and PFNA groups. The patients were followed up for 10 months.
The PFNA group comprised 26 men and 14 women aged 46 to 76 years (mean, 61.54 ± 3.15 years). Twenty-one patients presented with injury to the left and 19 with injury to the right. The causes of injury were falling (n = 10), traffic accidents (n = 12), and heavy crush injuries (n = 18). According to the Seinsheimer classification, the patients had type III (n = 15), type IV (n = 11), and type V fractures (n = 14). The LCP group comprised 25 men and 15 women aged 47 to 75 years (mean, 61.47 ± 3.31 years). Twenty-two patients presented with injury to the left and 18 with injury to the right. The causes of injury were falling (n = 13), traffic accidents (n = 14), and heavy crush injuries (n = 13). According to the Seinsheimer classification, the patients had type III (n = 16), type IV (n = 12), and type V fractures (n = 12). No significant difference in age, sex, cause of injury, or type of fracture was found between the two groups (P > 0.05).
Comparison of intraoperative and postoperative related indicators between the two groups
The intraoperative blood loss, operation time, incision length, hospital stay, and fracture healing time were lower in the PFNA than LCP group (P < 0.05) [Table 4].
|Table 4: Comparison of related indexes between the two groups during and after the operation|
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Comparison of hip function between the two groups
The rate of excellent and good Harris hip scores was slightly higher in the PFNA group (90.0%) than in the LCP group (72.5%) (P > 0.05) [Table 5].
|Table 5: Comparison of the excellent and good rate of Harris hip score between the two groups|
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Adverse events and harms
In the PFNA group, one patient developed deep vein thrombosis, two developed urinary system infection, and one developed pulmonary infection. The incidence of adverse events was 10%. In the LCP group, two patients developed deep vein thrombosis, two developed urinary system infection, and one developed pulmonary infection. The incidence of adverse events was 12.5%. No significant difference in the incidence of adverse events was detected between the two groups (P > 0.05).
The imaging findings of representative patients in the two groups before and after treatment are shown in [Figure 4] and [Figure 5].
|Figure 4: Imaging findings of a 30-year-old man with left thigh injury caused by a traffic accident in the proximal femoral nail antirotation group before and after treatment.|
Note: (A) The preoperative X-ray film demonstrated a left femoral subtrochanteric long- and short-segment comminuted fracture with the fracture line extending to 7 cm below the lesser trochanter. After admission, the patient underwent left femoral supracondylar traction for 5 days followed by proximal femoral nail antirotation. (B) In the 2-month postoperative X-ray film, the distal and proximal segments of the fracture site were repositioned well without displacement and without loosening of the nail. (C) In the 10-month follow-up X-ray film, the fracture line disappeared.
Click here to view
|Figure 5: Imaging findings of a 40-year-old man with left thigh injury caused by falling from a high position in the locking compression plate group before and after treatment.|
Note: (A) The preoperative X-ray film demonstrated a subtrochanteric comminuted fracture of the left femur with the fracture line extending to 20 cm below the lesser trochanter. After admission, the patient underwent left tibial subtubercular bone traction for 5 days followed by anatomical locking compression plate fixation. (B) The 2-month postoperative X-ray film showed that the distal and proximal segments of the fracture site were repositioned well without displacement and without loosening of the screw. (C) The 10-month follow-up X-ray film showed that the fracture line disappeared
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| Discussion|| |
Limitations of this study
Due to the limited hospital conditions, this study will fail to achieve randomization and blind grouping. The follow-up time will be relatively short; >1-year long-term follow-up results will be lacking. These limitations will have an impact on the accuracy of the results, which will need to be continuously improved in future research.
The results of the pilot study showed that both PFNA fixation and anatomical LCP fixation for treating long-segment comminuted subtrochanteric fracture of the femur achieved good therapeutic effects. Compared with LCP fixation, PFNA fixation had better efficacy, less trauma, and fewer complications and contributed more to early recovery. Therefore, this trial will expand the sample size and further validate the findings of the pilot study through a prospective, single-center, non-randomized, and controlled clinical trial.
Analysis of completed small-sample-size test results
The hospital stay and fracture healing time were shorter in the PFNA than LCP group, indicating that PFNA fixation effectively shortened the fracture healing time and was conducive to early recovery. The nail is stably supported by a spiral blade, which has strong resistance to rotation and varus deformity. The operation is relatively simple and helps the patient to carry out weight-bearing activities at an early stage. During fixation with the anatomical LCP, the exposed area is wide, the fracture ends are damaged to a certain extent, and the intraoperative blood loss volume is larger compared with PFNA fixation. Guo and Zhang suggested that the rate of an excellent and good outcome was as high as 92% in 70 patients with long-segment comminuted subtrochanteric fracture of the femur undergoing PNFA fixation. Our pilot results demonstrated that the rate of excellent and good outcomes was 72.5% in the LCP group, which is consistent with the above results. The results showed that the complication rate was lower, intraoperative blood loss volume was smaller, and operation time and incision length were shorter in the PFNA than LCP group. These findings confirm that the efficacy of PFNA fixation in the treatment of long-segment comminuted subtrochanteric fracture of the femur is better than that of LCP fixation.
Novelty of this study
Long-segment comminuted subtrochanteric fracture of the femur is a common hip fracture in the clinical setting. Its anatomical structure is special and its treatment is relatively difficult. Anatomical LCP and PFNA fixation are common treatment options for long-segment comminuted subtrochanteric fracture of the femur. Instead of conventional surgical treatment, proximal femoral anatomical LCP and PFNA devices will be used for surgical treatment in the present study. The surgical procedures of these two methods will be studied in detail.
Long-segment comminuted subtrochanteric fracture of the femur is a common trauma that is usually caused by violent injury. Many clinical treatments of this condition are currently available, including traction, minimally invasive internal fixation, external fixation, and conservative treatment. Conservative treatment readily results in hypostatic pneumonia. Traction and external fixation are helpful for fracture reduction and limb exercise, but improper manipulation can easily injure joints, resulting in bone splitting. Minimally invasive internal fixation easily causes fixator loosening, and the treatment effect is not ideal.
The anatomical LCP is extensively utilized to treat long-segment comminuted subtrochanteric fracture of the femur. This anatomical plate can completely cover the external part of the greater trochanter when the proximal part of the plate is flattened. Screws with different opening directions firmly fix the femoral head, have strong pull-out resistance, and effectively prevent postoperative rotation. Furthermore, this treatment method is applicable to patients with osteoporosis. During the operation, multiple locking nails can be used to maintain a normal collodiaphyseal angle without orthopedic treatment of the plate. An anatomical plate has the characteristic of elastic fixation, which has a good inductive effect on the fracture without inducing a cortical defect, thus contributing to fracture healing.
PFNA fixation is also a commonly used treatment for long-segment comminuted subtrochanteric fracture of the femur. During the operation, spiral blade locking is used instead of nail fixation. When the blade enters the bone, it plays a filling role without hole enlargement. The locked blade can be strongly anchored with the bone, thereby effectively preventing loosening and withdrawal. The PFNA device is part of an intramedullary fixation system and does not readily produce coxa vara. The displacement of the lesser trochanter does not need to be repositioned and fixed again, which can reduce surgical trauma to a certain extent. The distance between the groove of the main nail and the tail of the nail is relatively long, which helps to reduce the stress concentration of the diaphysis, thus avoiding diaphyseal fracture. Moreover, the main nail is hollow and has an external deflection angle, which helps with insertion in the proximal femoral medullary cavity, minimizes the impact on the blood circulation of the femoral head and neck, and shortens the fracture healing time. Intramedullary nails play an important supporting role in the femoral head and can effectively prevent the collapse and outward displacement of bone blocks. Intramedullary nails can also maintain fracture stability and retain some fretting. This design is in line with the principle of biological fixation. Hou et al. verified that the fracture healing time and hospital stay were relatively shorter in 90 patients with long-segment comminuted subtrochanteric fracture of the femur undergoing PFNA fixation. Our small-sample-size results displayed that the hospital stay and fracture healing time were shorter in the PFNA than LCP group, indicating that PFNA treatment can effectively shorten the fracture healing time and is conducive to early recovery. The nail is stably supported by a spiral blade, which has strong resistance to rotation and varus deformity. The operation is relatively simple and helps the patient to carry out weight-bearing activities at an early stage.
Registration: February 3, 2019.
Patient recruitment and data collection: June 30, 2019–June 30, 2020.
Study completed: August 1, 2022.
Trial status: Active, not recruiting.
Additional file 1: Hospital Ethics Approval (Chinese).
Additional file 2: TREND checklist.
Additional file 3: Informed Consent Form (Chinese).
All authors contributed to the study design, subject recruitment and data analysis, and approved the final version of this manuscript.
Conflicts of interest
The authors have no conflicts of interest to declare.
Institutional review board statement
This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. The study was approved by the Medical Ethics Committee of Sanya Traditional Chinese Medicine Hospital in China in March 2013 (approval No. (2013) (02)).
Declaration of patient consent
The authors certify that they will obtain all appropriate patient consent forms. In the forms, the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
This study followed the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement.
The statistical methods of this study were reviewed by the biostatistician of Sanya Traditional Chinese Medicine Hospital in China.
Copyright license agreement
The Copyright License Agreement has been signed by all authors before publication.
Data sharing statement
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available immediately following publication, with no end date. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com.
Checked twice by iThenticate.
Externally peer reviewed.
S-Editors: Wang J, Li CH; L-Editors: Morben A, Qiu Y, Wang L; T-Editor: Jia Y
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]