Table of Contents  
STUDY PROTOCOL
Year : 2018  |  Volume : 3  |  Issue : 1  |  Page : 24-31

A new fixation and reconstruction method versus arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results


1 Third Department of Orthopedics, Cangzhou Central Hospital, Cangzhou, Hebei Province, China
2 Department of Joint Surgery, Xinjiang Military General Hospital, Urumqi, Xinjiang Uygur Autonomous Region, China

Date of Web Publication21-Mar-2018

Correspondence Address:
Guang-dong Chen
Third Department of Orthopedics, Cangzhou Central Hospital, Cangzhou, Hebei Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.227049

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  Abstract 

Background and objectives: Arthroscopic reconstruction for treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament (PCL) can minimize surgical trauma to the largest degree. However, its implants have relatively poor stability; therefore, functional exercise cannot be performed in the early stages after surgery, which is inconducive to knee function recovery. It is extremely challenging to perform traditional open reduction with internal fixation to repair avulsion fractures at the tibial insertion of the knee PCL. Often, the crushed bones cannot be firmly fixed because of their small size, leading to a poor repair effect. Therefore, we designed a new inverted “L”-shaped incision in the popliteal fossa through which bone plates were inserted to fix the crushed bones and to reconstruct PCL tension, facilitating knee function recovery. In this study, we plan to compare the therapeutic effects of this new fixation and reconstruction method, and arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee PCL.
Design: A prospective, single-center, non-randomized controlled trial.
Methods: One hundred and eighty patients (knees) with avulsion fracture at the tibial insertion of the knee PCL will be assigned to two groups based on treatment methods: arthroscopic reconstruction group (n = 90; fracture fixation and repair under the arthroscope) and new method group (n = 90; bone plates will be inserted through an “L”-shaped incision in the popliteal fossa to fix the crushed bones and reconstruct PCL tension). After surgery, these patients will be followed up for 6 weeks, 6 months, and 12 months.
Outcome measures and preliminary results: The primary outcome measure is the excellent and good rate of knee function recovery at 12 months after surgery as evaluated by Lysholm Knee Scoring Scale score (herein referred to as Lysholm score). The secondary outcome measures are the excellent and good rate of knee function recovery before surgery, 6 weeks and 6 months after surgery; Lysholm score before surgery, 6 weeks, 6 months and 12 months after surgery; Hospital for Special Surgery (HSS) knee score, Visual Analogue Scale (VAS) score, posterior drawer test negative rate, X-ray morphology of the knee before surgery, and 6 weeks, 6 months, and 12 months after surgery and; incidence of adverse events at 6 weeks, 6 months and 12 months after surgery. Results of a preliminary study involving 62 patients (knees) with avulsion fracture at the tibial insertion of the knee PCL showed that posterior drawer test negative rate and Lysholm score were significantly higher in the new method group compared to the arthroscopic reconstruction group (P < 0.05) at 3 months after surgery.
Discussion: This study will be performed to compare the therapeutic effects of bone plate insertion through an “L”-shaped incision made in the popliteal fossa to fix the crushed bones and to reconstruct PCL tension, and traditional fracture fixation and repair under the arthroscope to treat avulsion fracture at the tibial insertion of the knee PCL. We believe that the former method will be superior to the latter one because it can fix the avulsion fracture more firmly, facilitating knee function recovery.
Ethics and dissemination: This study has been approved by Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. This study was designed in December 2017. Patient recruitment and data collection will begin in April 2018. Patient recruitment will end in June 2019. Data analysis will be performed in August 2020. The study will be completed in October 2020. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.
Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR1800015026). Protocol version: 1.0.

Keywords: popliteal fossa; ligament; arthroscope; open reduction and internal fixation; Lysholm score; Hospital for Special Surgery knee score; posterior drawer test; X-ray; knee range of motion; adverse reaction


How to cite this article:
Chen Gd, Zhang Y, Ni Yj, Du Hm, Cao Tj, Shan Zl. A new fixation and reconstruction method versus arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results. Clin Trials Orthop Disord 2018;3:24-31

How to cite this URL:
Chen Gd, Zhang Y, Ni Yj, Du Hm, Cao Tj, Shan Zl. A new fixation and reconstruction method versus arthroscopic reconstruction for treating avulsion fracture at the tibial insertion of the knee posterior cruciate ligament: study protocol for a non-randomized controlled trial and preliminary results. Clin Trials Orthop Disord [serial online] 2018 [cited 2024 Mar 29];3:24-31. Available from: https://www.clinicalto.com/text.asp?2018/3/1/24/227049


  Introduction Top


Research background

Avulsion fractures at the tibial insertion of the knee posterior cruciate ligament (PCL) can lead to backward movement and instability of the knee joint.[1],[2],[3],[4],[5] Surgical treatments include open reduction and arthroscopic reduction followed by internal fixation. Arthroscopic surgery can minimize surgical trauma to the largest degree, but it provides relatively weak fixation, and patients cannot perform functional exercise during early stages.[6],[7] However, early functional exercise can promote rapid recovery of the knee function. Therefore, open reduction is strongly recommended. In previous reports, steel wire, high-strength sutures, hollow screws, absorbable screws, and rivets were used to fix avulsion fractures at the tibial insertion of the PCL.[8],[9],[10],[11] Comminuted bone blocks are often not fixed firmly using the above-mentioned sutures or screws. In addition, long-term external fixation is required and the time required for knee function recovery is prolonged. We reviewed three clinical trials on the repair of knee PCL injury and their relevant contents are shown in [Table 1].[12],[13],[14]
Table 1: Three clinical trials regarding repair of knee posterior cruciate ligament reported during 2013–2014

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Novelty of this study

We designed a new inverted “L”-shaped incision in the popliteal fossa through which bone plates are inserted to fix the crushed bones and reconstruct PCL tension, facilitating knee function recovery.

Main objective

In this study, we will compare the therapeutic effects of this new fixation and reconstruction method, and arthroscopic reconstruction for avulsion fractures at the tibial insertion of the knee PCL.


  Methods/Design Top


Study design

A prospective, single-center, non-controlled, interventional trial.

Study setting

Department of Orthopedics, Cangzhou Central Hospital, Hebei Province, China.

Recruitment

Recruitment will be performed using a leaflet to advertise for patients at the Cangzhou Central Hospital of China. Leaflets would provide detailed information regarding the clinical trial. After being informed of the trial and its related interventions, patients interested in participation or their close relatives will fill-in the necessary paperwork, and confirmed participants will be grouped according to the eligibility criteria.

Patient selection

Inclusion criteria

Patients meeting all of the following conditions will be considered for inclusion:

  • Patients with avulsion fracture at the tibial insertion of the knee PCL
  • Limited knee flexion and extension abilities, posterior drawer test (+)
  • Presence of joint trauma
  • Age 35–58 years
  • Provision of written informed consent


Exclusion criteria

Participants with one or more of the following conditions will be excluded from this study:

  • Patients with old fracture(s)
  • Patients with fracture complicated by 2nd degree or mores vere medial collateral ligament injury
  • Patients with anterior cruciate ligament injury
  • Patients with injury to the posterolateral corner of the knee


Grouping and blinding

Prior to surgery, the two therapeutic regimens will be explained in detail to patients. Surgical methods will be chosen by patients and their family members, and patients will be grouped in the arthroscopic reconstruction or the new method groups accordingly. Randomization and blinded grouping will not be used.

Interventions

In both groups, patients will undergo surgery under continuous epidural anesthesia and assistance by a tourniquet.

(1) Pre-operative preparations: All included patients will undergo routine X-ray, CT, and MRI examinations. Substantial ligament injury and the accompanying meniscal injury will be screened according to MRI findings.

(2) Intervention in the arthroscopic reconstruction group: Anteromedial and anterolateral space of the knee joint will be examined through the anteromedial and anterolateral approaches. Posteromedial and posterolateral approaches will be established to be used as observation and working channels. Arthroscopic examination of the fracture will be performed. After removal of fracture stumps, a probe will be inserted through the established posterolateral approach of the knee joint to reset bone fragments. Guide pins will be introduced via the working channel and fixed. PCL will be strengthened under the assistance of a PCL femoral sight located at fracture stumps. Two Kirschner wires will be drilled via the fracture stumps. No. 5 ETHIBOND EXCEL polyester sutures will be introduced into the knee joint through the on-side channel, passed through the base of the tibial insertion of PCL to cross the channel on the other side, and finally exited out of the knee joint in flexion 90° position. The tibia will be pulled forward. The No. 5 ETHIBOND EXCEL polyester suture will be ligated right before the tibial tubercle.

(3) Intervention in the new method group: After successful anesthesia, the patient will be placed in the prone position. A median inverted “L”-shaped incision will be made in the direction of medial dermatoglyph in the popliteal fossa along the upper border of the gastrocnemius muscle. The target skin will be cut open and the deep fascia will be longitudinally incised. Next, loose tissue between the semitendinosus and medial gastrocnemius will be separated to expose the posterior capsule. In the articular capsule of the knee joint, PCL with avulsion or more severe injury will be reconstructed using tendon sutures. PCL tightening by proper traction can easily reduce bone fragments at the tibial insertion of PCL. The bone plates used for reconstruction will be placed in the median upper border of the posterior tibial plateau and fixed with cancellous bone screws. The woven suture will be fixed in the hole of the self-made internal fixation device (a national patent patent number: ZL 2016 2 0025670.3). PCL tension will be examined again and knee stability will be examined in the positions of flexion and extension [Figure 1].
Figure 1: Schematic diagram of new fixation reconstruction surgery.

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(4) Postoperative management

Arthroscopic reconstruction group: All patients will undergo early passive knee extension exercise. After surgery, each patient will wear a brace for 6 weeks. The knee in the position of extension will be fixed for 2 weeks to perform knee function exercise. Partial body weight bearing exercises will begin 5 weeks after surgery and full body weight bearing exercises will begin at 7 weeks after surgery.

New method group: On the day of surgery, when anesthesia disappears, toe plantar flexion and extension on the affected side will be performed. On day 2 after surgery, subsequent to removal of the wound drainage device, the affected limb will be allowed to perform non-weight bearing walk with the help of walking sticks for quadriceps’ functional exercise. Passive knee flexion exercises will be performed 1 week later. Active knee exercises under the protection will start at 3 or 4 weeks after surgery. At postoperative 6 weeks, patients will be allowed full weight bearing exercises if X-ray findings show satisfactory bone fracture healing and good internal fixation position.

Criteria for termination or modification of interventions

assigned to subjects

If the investigators find that the risks outweigh the potential benefit, or conclude that the risk is sufficient to undermine the safety and efficacy of the surgery, they will inform the subjects that the clinical trial will be suspended or terminated, and ensure that the subjects receive appropriate treatment and follow-up. In addition, the investigators will inform the sponsor and ethics committee, by providing a detailed written explanation regarding suspension or termination of the clinical trial.

Outcome measures

Primary outcome measure

  • Excellent and good rate of knee function recovery at 12 months after surgery, as evaluated by the Lysholm Knee Scoring Scale score (referred to as Lysholm score below). The Lysholm Knee Scoring Scale includes 8 items with a total score of 0–100 points. A score of 95 or higher is considered excellent, 94–85 good, 84–65 fair, and a score of 65 or lower poor. The rate of excellent and good Lysholm scores will be calculated as: number of patients who scored ≥ 85 /total number of patients ×100%. A higher score will indicate better knee function recovery.


Secondary outcome measures

  • Excellent and good rate of knee function recovery as evaluated by the Lysholm score before surgery, and 6 weeks and 6 months after surgery. The scoring criteria will be the same as above.
  • Lysholm scores before surgery, 6 weeks, 6 months and 12 months after surgery. The scoring criteria will be the same as above.
  • Hospital for Special Surgery (HSS) knee scores before surgery, 6 weeks, 6 months and 12 months after surgery: This score will be used to summarize symptoms and clinical signs: pain (30 points), function (22 points), muscle strength (10 points), flexion deformity (10 points), instability (10 points), range of motion (18 points). The overall scores will be graded as excellent (≥ 85 points), good (70–84 points), fair (60–69 points) and poor (< 59 points). [15] Higher scores would indicate better knee function recovery.
  • Visual Analogue Scale (VAS) scores before surgery, 6 weeks, 6 months and 12 months after surgery: The VAS score ranges from 0–10 points. Higher scores indicate more severe neck pain in the patient.[16]
  • Posterior drawer test negative rate: The posterior drawer test will be used to examine the PCL. Patients will lie in the supine position with knees bent at 90º, both hands placed behind the knee joint, and thumbs placed on the extensor side. The proximal calf will be repeatedly pushed and pulled. If the tibia moves backwards on the femur, a partially or completely fragmented PCL will be considered. If the tibia does not move on the femur, no fragmentation of PCL will be considered. Posterior drawer test negative rate will be calculated as: number of patients with negative results of posterior drawer test/total number of patients × 100%. Higher values would suggest better recovery of the PCL structure.
  • X-ray morphology of the knee before surgery, at 6 weeks, 6 months and 12 months after surgery: X-ray morphology of the knee in the anterio-posterior view will be examined, which will be used to determine the extent of repair of the injured bone and ligament.
  • Incidence of adverse events 6 weeks, 6 months and 12 months after surgery: Adverse events include incision pain, infection, knee pain, peripheral nerve injury, and deep venous thrombosis. Incidence of adverse events = number of patients having adverse events/total number of patients ×100%.


Timing of outcome assessment

The scheme of primary and secondary outcome measures is shown in [Table 2].
Table 2: Timing of primary and secondary outcome measures

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Adverse events

Any medical abnormalities that occur between the period starting from the provision of signed informed consent and recruitment to the end of the observation period, regardless of whether they are directly associated with the surgical treatment or not, will be considered as adverse events. During the study period, adverse events (including name, start and end time, severity, relationship with known events, and treatment measures) will be accurately recorded. Judgment and treatment of severe adverse events: any medical events including death, prolonged hospitalization, re-hospitalization, fetal diseases, permanent defects in body structure or body function, and medical treatment or surgical intervention to avoid permanent defects in body structure or body function, will be considered as severe adverse events. During follow-up, the start time and type of severe adverse events as well as the treatment measures will be recorded in detail. After occurrence of the adverse event, relevant information will be reported to the principal investigator and the institutional review board within 24 hours.

Trial procedure

One hundred and eighty patients (knees) with avulsion fracture at the tibial insertion of the knee PCL will be assigned to two groups as per the respective treatment method: arthroscopic reconstruction group (n = 90) and new method group (n = 90). The trial procedure is shown in [Figure 2].
Figure 2: Flow chart of the study.
Note: PCL: Posterior cruciate ligament; HSS: Hospital for Special Surgery; VAS: Visual Analogue Scale.


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Sample size

In accordance with previous reports[17],[18] and our experience, we hypothesized that the excellent and good rates of knee function recovery at 12 months after surgery as evaluated by Lysholm score would be 80% and 90%, in the arthroscopic reconstruction and new method groups, respectively. Assuming β = 0.1, power = 90%, and α = 0.05 (two-sided), a final effective sample size of n = 75 was calculated using the PASS 11.0 software (PASS, Kaysville, UT, USA). Assuming a participant loss rate of 20%, we would require 90 participants per group.

Statistical analysis

Data description

All data will be statistically processed using the SPSS 19.0 software (IBM, New York, NY, USA), following the intention-to-treat principle. Normally distributed measurement data will be expressed as means and standard deviations. Non-normally distributed data will be expressed as lower quartiles (q1), medians, and upper quartiles (q3). Count data will be expressed as percentages.

Selection of statistical methods

Pearson chi-square test will be used to compare the excellent and good rates of knee function recovery as evaluated by the Lysholm score, Posterior drawer test negative rate, and incidence of adverse events between the arthroscopic reconstruction and new method groups. Kruskal-Wallis H test will be used to compare the above indices between different time points in each group. Two-sample t-test (normally distributed data) or Mann-Whitney U test (non-normally distributed data) will be used to compare the HSS knee scores and VAS scores between the two groups. Repeated measures analysis of variance will be used for comparison of the above-mentioned indices between different time points in the same group. An inspection level of α = 0.05 (unilateral) will be considered.

Data sets

Included subjects will consist of populations assigned to each protocol set. These will be subjects who meet the inclusion and exclusion criteria, complete the study without major protocol deviations, provide effective baseline efficacy and tight compliance, and complete the case report form.

Data collection and management

Data collection

Case report forms will be filled by the investigators accurately, completely, and on time. Written records including demographic information, disease classification, accompanying diseases, and adverse events will be transferred to an electronic format by professional staff using a double data entry strategy.

Data management

Only the project manager will have the right to inquire about the database, which will be locked by the project manager themselves. All research materials related to this trial will be preserved by the Cangzhou Central Hospital, China. Research data will be monitored and managed by an Independent Data Monitoring Committee throughout the clinical research process to ensure scientific integrity and rigor, as well as obtain true and complete data. Two staff members will be responsible for transcribing the required information on results. Data will be recorded and checked by investigators and the database will be locked.

Data monitoring

Independent Data Monitoring Committee composition

The role and responsibilities of the Independent Data Monitoring Committee relative to the investigators and ethics committee will be identified. The role and responsibilities of the Independent Data Monitoring Committee will be relative to the project steering committee, statisticians, data managers, inspectors, and sponsors.

Investigator qualification

All surgeons participating in this study have a wealth of orthopedic surgery and arthroscopy experience. The surgery will be performed by orthopedic chief surgeons and senior associated chief surgeons.

Auditing

All data will be checked for its accuracy and completeness as well as consistency with original records. All corrected or commented mistakes will be signed and dated by the investigators. Each subject’s dose change, treatment change, combined medication, intermittent disease, loss of follow up, and missed examinations will be confirmed and recorded. The dropout and lost to follow up subjects will be recorded in the Case Report Form.

Compensation to study participants

Patients included in this program will receive complimentary study protocol-related laboratory and imaging examinations during the follow-up period, and will also receive a transportation allowance.

Ethics and dissemination

The study design has been approved by the Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). This study will be performed in strict accordance with the principles outlined in the Declaration of Helsinki formulated by the World Medical Association. Participants will provide signed informed consent prior to participation in the study. If and when any unexpected risk occurs during the clinical trial, informed consent-related content will be modified in accordance with the sponsor. After receiving agreement by the ethics committee, informed consent will be obtained again by the involved subjects or their guardians. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be published at www.figshare.com.


  Preliminary Results Top


Results of a preliminary study involving 62 patients with avulsion fracture at the tibial insertion of the knee posterior cruciate ligament who underwent the above described treatment protocol revealed that the time for surgery in the new method group was shorter than that in the arthroscopic reconstruction group (P < 0.05; [Table 3]). The included 62 patients were followed up for an average time of 18.2 (range 12–24 months) months. Poor reduction was found in 8 out of 31 patients in the arthroscopic reconstruction group and in 2 out of 31 patients in the new method group. Follow-up results showed that in the new method group, 1 patient felt mild soreness in the rear of knee joint during flexion and extension activities, but this did not affect activities of normal life. Images of a typical case are shown in [Figure 3] and [Figure 4].
Table 3: Follow-up results of arthroscopic reconstruction and new method groups at 3 months after surgery (n = 31/group)

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Figure 3: Images of a 38-year-old male patient with avulsion fracture at the tibial insertion of the left knee posterior cruciate ligament before and after arthroscopic surgical treatment.
Note: Arthroscopic anterolateral, anteromedial, posteromedial, and posterolateral approach examination followed by suture and fixation of the tibial insertion of the knee posterior cruciate ligament. (A, B) Three-dimensional and sagittal CT reconstruction of the avulsion fracture at the tibial plateau; (C, D) MRI images of the avulsion fracture at the tibial plateau; (E) arthroscopic image of the avulsion fracture at the tibial plateau; (F, G) anterioposterior X-ray image of the knee joint at 3 days after arthroscopic surgical treatment.


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Figure 4: Images of a 46-year-old male patient with avulsion fracture at the tibial insertion of the left knee posterior cruciate ligament complicated by contralateral femoral shaft fracture and multiple limb fractures.
Note: The patient underwent posterior open reduction with internal fixation by bone plate as well as posterior cruciate ligament reconstruction using the fixation device. (A, B) X-ray images of the avulsion fracture at the tibial plateau before surgery; (C, D) three-dimensional and sagittal CT reconstruction of the avulsion fracture at the tibial plateau before surgery; (E) MRI image of the avulsion fracture at the tibial plateau; (F, G) anterioposterior X-ray image of the knee joint at 1 month after surgery.


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At 3 months after surgery, the posterior drawer test negative rate and Lysholm score in the new method group were significantly higher than those in the arthroscopic reconstruction group (P < 0.05; [Table 3]).


  Discussion Top


Past contributions and existing problems of others in the field of research

Surgical methods for the treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament mainly include open reduction with internal fixation and arthroscopic reduction. Each method has its advantages and shortcomings. Arthroscopic reduction is relatively minimally invasive. It can find and treat other articular cavity disorders, but the tibial insertion of the knee posterior cruciate ligament is located in the posterior tibial plateau; therefore, arthroscopic reduction for the treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament is quite challenging.[19] Arthroscopic surgery has shortcomings including complex operation, longer operative time, and inaccurate fracture reduction.[20] A few scholars consider that a part of the tibial insertion of the posterior cruciate ligament is located outside the articular capsule. When an avulsion fracture at the tibial insertion of the posterior cruciate ligament occurs, this articular capsule and other soft tissues often cause the fracture reduction to be difficult and fixation to be not firm, which in-turn is unsuitable for performing early functional exercise.[21]

Features of this study

In this study, we designed and proposed a novel method to fix the avulsion fracture at the tibial insertion of the knee posterior cruciate ligament. Compared to arthroscopic reconstruction, this novel method provides more firm fixation, reduces operative time, enables reconstruction of knee posterior cruciate ligament, provides better ligament tension, and maintains a more stable knee function, which offers patients with early opportunities of postoperative functional exercise. The anatomical design of the fixation device was approved by the national patent organization for its simple light weight feature and fewer adverse reactions.

Limitations of this study

In this study, random grouping will not be used, and the proposed follow up time is short. These factors will influence the accuracy of experimental results.

Significance of this study

Findings from this study will provide evidence to identify whether fixation of crushed bones using bone plates inserted through an inverted “L”-shaped incision in the popliteal fossa and reconstruction of ligament tension provides superior repair and safety in the treatment of avulsion fracture at the tibial insertion of the knee posterior cruciate ligament compared to arthroscopic reconstruction.

Additional file

Additional file 1: SPIRIT checklist. [Additional file 1]

 
  References Top

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Ambra LF, Franciozi CE, Werneck LG, et al. Posteromedial vesus direct posterior approach for posterior cruciate ligament reinsertion. Orthopedics. 2016;39:e1024-1027.  Back to cited text no. 1
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Author contributions
This study was designed by GDC. YJN and HMD will be responsible for participant recruitment. YZ will be responsible for data collection and analysis. TJC will assist with surgery. ZLS will be responsible for project coordination. All authors approved the final version of this manuscript for publication.
Conflicts of interest
All authors declare that no competing interests exist.
Financial support
None.
Research ethics
This study was approved by Medical Ethics Committee of Cangzhou Central Hospital of China (approval No. 2017-120-01). The study will be performed in accordance with the Declaration of Helsinki.
Declaration of patient consent
The authors certify that they will obtain patient consent forms. In the form, patients will give their consent for their images and other clinical information to be reported in the journal. The patients will 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.
Data sharing statement
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be in particular shared. Study protocol and informed consent form will be available. The data will be available immediately following publication without 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.
Plagiarism check
Checked twice by iThenticate.
Peer review
Externally peer reviewed.


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]


This article has been cited by
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Xiang Yao, Minjie Hu, Hongyuan Liu, Jilei Tang, Jishan Yuan, Kaihua Zhou
International Orthopaedics. 2022;
[Pubmed] | [DOI]



 

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