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 Table of Contents  
RESEARCH ARTICLE
Year : 2019  |  Volume : 4  |  Issue : 2  |  Page : 34-40

Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial


1 Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan, Gansu Province, China
2 Department of Orthopedics, Second Clinical Medical College of Lanzhou University, Lanzhou, Gansu Province, China

Date of Submission07-Jan-2019
Date of Acceptance27-Feb-2019
Date of Web Publication7-Jun-2019

Correspondence Address:
Xiao-Guang Yang
Third Department of Orthopedics, No. 1 Hospital of Longnan City, Longnan, Gansu Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-4157.259630

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  Abstract 


Background and objective: Anterior cruciate ligament tibial eminence avulsion fractures are repaired via early open reduction. Choosing the best fixation method in accordance with the bone size can effectively promote restoration of the cruciate ligament to its normal anatomical position and achieve bone healing. The use of absorbable screws for internal fixation of anterior cruciate ligament tibial eminence avulsion fractures reportedly promotes fracture healing, but the efficacy and safety need further clarification. The present study aims to observe the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture.
Participants and methods: This prospective, single-center, self-controlled trial will include 72 patients with anterior cruciate ligament tibial eminence avulsion fractures. Open reduction and internal fixation with absorbable screws will be performed through a small incision. All patients will be followed up at 3, 6, and 12 months postoperatively. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02). Protocol version is 1.0. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants’ family members or the participants themselves.
Results: The primary outcome measure is the recovery of knee function assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. Secondary outcome measures are the Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively, the International Knee Documentation Committee scores, knee range of motion, knee morphology on radiographs and magnetic resonance images preoperatively and 3, 6, and 12 months postoperatively, and the incidences of adverse reactions 3, 6, and 12 months postoperatively. In our pilot study involving 50 patients with anterior cruciate ligament tibial eminence avulsion fractures (50 knees) from October 2015 to January 2018, no patient had joint stiffness or fracture redisplacement on radiography 3 months postoperatively. The mean knee range of motion was significantly larger at 6 months postoperatively compared with preoperatively (P < 0.05). Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores were significantly improved 6 months postoperatively compared with preoperatively (P < 0.05).
Conclusion: This trial will assess the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision to restore knee function in patients with anterior cruciate ligament tibial eminence avulsion fracture.
Trial registration: This study was registered with the Chinese Clinical Trial Registry on March 13, 2019 (registration number: ChiCTR1900021865).

Keywords: anterior cruciate ligament tibial eminence avulsion fracture; open reduction; absorbable screws; internal fixation; Lysholm Knee Scoring Scale score; International Knee Documentation Committee score; self-controlled study


How to cite this article:
Yang XG, Wang YZ. Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial. Clin Trials Orthop Disord 2019;4:34-40

How to cite this URL:
Yang XG, Wang YZ. Efficacy and safety of small-incision open reduction and internal fixation with absorbable screws for anterior cruciate ligament tibial eminence avulsion fractures: a self-controlled clinical trial. Clin Trials Orthop Disord [serial online] 2019 [cited 2019 Jun 18];4:34-40. Available from: http://www.clinicalto.com/text.asp?2019/4/2/34/259630


  Introduction Top


Background

Anterior cruciate ligament tibial eminence avulsion fracture is a special type of intraarticular fracture that is common in clinical practice, usually occurs in children and adolescents, and is often accompanied by meniscal damage and collateral ligament injury.[1],[2],[3],[4] If left untreated, this type of fracture seriously affects the stability of the knee joint of the patient, eventually causing traumatic arthritis, knee flexion, and extension dysfunction. The anterior cruciate ligament tibial eminence is mainly located in the anterolateral part of the tibial intercondylar eminence. The anterior cruciate ligament not only restricts tibial migration and prevents overstretching, but also effectively counteracts varus and valgus angulation when the knee is in full extension. Thus, avulsion fracture causes marked instability of the knee joint, which not only affects normal knee function, but also damages the menisci and articular cartilage.[5],[6],[7],[8]

Treatment of anterior cruciate ligament tibial eminence avulsion fractures via traditional open surgery induces surgical trauma, prolonged hospital stay, and difficult postoperative recovery, and also causes knee adhesions and stiffness, seriously affecting the prognosis.[9],[10]

Early open reduction of anterior cruciate ligament tibial eminence avulsion fracture and selection of the best fixation method in accordance with the bone size promote recovery of the cruciate ligament to its normal anatomical position and achieves bone healing. A previous study confirmed that internal fixation with absorbable screws for the treatment of anterior cruciate ligament tibial eminence avulsion fracture effectively promotes fracture healing,[11] but the efficacy and safety need to be further explored.

We searched the PubMed database for studies published from January 2014 to December 2018 using the search term “anterior cruciate ligament tibial eminence avulsion fracture” and identified and reviewed the three most recent studies evaluating the repair of anterior cruciate ligament tibial eminence avulsion fracture [Table 1].[2],[12],[13]
Table 1: Three most representative retrospective studies regarding the repair of anterior cruciate ligament combined with tibial fractures

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Main objective

This trial will evaluate the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture during 1 year of follow-up.


  Participants and Methods Top


Design

Prospective, single-center, self-controlled trial.

Setting

No. 1 Hospital of Longnan City, Longnan, Gansu Province, China.

Clinician qualifications

All surgeons who will be performing surgery, imaging examination, and knee function evaluation in this study have received professional medical training and have 5–10 years of clinical experience. The doctors are classified above the level of attending physician, and are qualified orthopedic specialists.

Participants

Recruitment

The study plan leaflets, containing trial information and participant’s benefits, will be dispatched in the No. 1 Hospital of Longnan City, China. Interested patients and their family members will contact the principal investigator. All patients will be included according to the eligibility criteria and after providing written informed consent.

Inclusion criteria

- CT and MRI examinations confirm large-area avulsion fracture of the lower ligaments and anterior cruciate ligament tibial eminence avulsion fracture.

- Fracture categorized as type II or III in accordance with the Meyer-Mckeever classification system[2]

- Patient age 10 to 50 years, irrespective of sex

- Provision of written informed consent

Exclusion criteria

- Intolerant of surgery or with infection around the knee

- Concurrent tibial plateau fracture and/or posteromedial or posterolateral structural injury

- Knee stiffness due to prior avulsion fracture

- Osteoarthritis

Provision of compensation

Patients who agree to use their clinical data for this trial will simultaneously be followed up by the professional medical team of No. 1 Hospital of Longnan City. The imaging examination fee and registration fee will be waived during follow-up.

Interventions

Implant information is shown in [Table 2].
Table 2: Characteristics of the absorbable bone fixation system

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Preoperative preparation

All patients will receive general anesthesia via laryngeal mask combined with femoral nerve block anesthesia. The patient will be in supine position with knee flexion of 90°. Balloon hemostasis will be performed at the root of the thigh and fixed with a baffle. The tourniquet pressure will be set at 280–300 mmHg (1 mmHg = 0.133 kPa). The arthroscope will be placed in the anterolateral knee to observe the characteristics of each compartment of the knee. The fracture area will be washed with normal saline. The fracture and pathological changes will be further evaluated, and the specific treatment plan will be determined. Chondroplasty will be performed in patients with concurrent cartilage injury. Sutures will be placed in patients with concurrent meniscal injury. In situ sutures will be placed in patients with concurrent avulsion fracture of the anterior horn of the lateral meniscus. Sutures will be placed in patients with concurrent medial collateral ligament injury.

Repair methods

The precise repair methods are shown in [Figure 1].
Figure 1: Flow chart of anterior cruciate ligament tibial eminence avulsion fracture repair using open reduction and internal fixation with absorbable screws through a small incision.

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Postoperative treatment

Postoperative anti-inflammatory therapy will be administered for 5–7 days. Functional recovery exercise will commence on postoperative day 1.

Outcome measures

Primary outcome measure

The recovery of knee function as assessed by the Lysholm Knee Scoring Scale score at 12 months postoperatively. The Lysholm Knee Scoring Scale includes eight items to produce a score of 0–100.[14],[15],[16] Knee function ratings of excellent, good, average, and poor are indicated by scores of ≥ 95, 94–85, 84–65, and < 65, respectively.

Secondary outcome measures

  • The Lysholm Knee Scoring Scale scores preoperatively and 3 and 6 months postoperatively. Evaluation criteria are the same as for the primary outcome measure.
  • International Knee Documentation Committee score. The International Knee Documentation Committee score is internationally recognized as having high reliability, effectiveness, and sensitivity in the assessment of ligament injury, especially anterior cruciate ligament injury and defect.[17],[18],[19],[20] Knee function will be assessed based on pain, stiffness, and joint function. The total International Knee Documentation Committee score is 100, with higher scores indicating better knee function.
  • Mean knee range of motion preoperatively and 3, 6, and 12 months postoperatively. Normal knee flexion-extension is defined as 0–130°, intorsion is defined as 0–30°, and extorsion is defined as 0–40°.
  • Knee morphology on radiographs obtained preoperatively and 3, 6, and 12 months postoperatively to evaluate fracture healing and internal fixation.
  • Knee morphology on MR images obtained preoperatively and 3, 6, and 12 months postoperatively to evaluate the repair of the knee ligaments.
  • Incidence of adverse reactions 3, 6, and 12 months postoperatively. Possible adverse reactions include delayed fracture union, infection, peripheral nerve injury, fracture redisplacement, and knee stiffness.


The assessors responsible for the knee function score and imaging will be unaware of the test plan. The schedule for the primary and secondary outcome measures is displayed in [Table 3].
Table 3: Timing of primary and secondary outcome measures

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Sample size

Since this is a self-controlled trial and patient control group is not set up, the researcher will recruit approximately 60 patients during the recruitment period (August 1, 2019 to December 1, 2020) according to the number of patients with anterior cruciate ligament tibial eminence avulsion fracture (50–60 cases per year) annually in the hospital. Assuming a patient loss rate of 20%, we will require 72 patients.

Ethical approval

This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02; [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 study follows the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals developed by the International Committee of Medical Journal Editors.

Informed consent

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 2].

Statistical analysis

All data will be statistically analyzed using SPSS 22.0 software (IBM Corp., Armonk, NY, USA). 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. Repeated-measures analysis of variance and the least significant difference test will be utilized to compare Lysholm Knee Scoring Scale scores and International Knee Documentation Committee scores at various time points after surgery. Main effects and interaction effects will be calculated. McNemar’s test will be applied to compare the incidence of adverse events at various time points. The significance level (two-sided) will be α = 0.05. All included patients will be assigned to the per-protocol set.


  Results Top


Study design flow chart

The flow chart of the study is shown in [Figure 2].
Figure 2: Trial flow chart.

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Patient recruitment

It is predicted that approximately 72 patients will be recruited from August 1, 2019 to December 1, 2020.

Baseline characteristics

The patient baseline data, including age, sex, injury side, cause of injury, and fracture classification, will be recorded in detail before surgery.

Outcome measures

The Lysholm Knee Scoring Scale scores, International Knee Documentation Committee scores, mean knee range of motion, knee morphology on radiography and MRI, and incidences of adverse reactions will be recorded in detail during follow-up.

Expected possible adverse reactions

The main adverse reactions are expected to be delayed fracture healing, infection, peripheral nerve injury, fracture redisplacement, and knee stiffness.

Any adverse event that occurs after repair of anterior cruciate ligament tibial eminence avulsion fracture will be reported within 24 hours. In this clinical study, any adverse events will be treated immediately, regardless of any treatment that the subject has received.

In the event of a serious adverse event (such as tibial refracture caused by other factors, bleeding, coma, and shock due to unforeseen factors), the clinician will report to the project manager and the leader of the office of the drug clinical trial institution within 1 hour, and take corresponding emergency treatment measures.

Pilot study results

Baseline data of 50 patients

The clinical data of 50 patients with anterior cruciate ligament tibial eminence avulsion fracture treated at the No. 1 Hospital of Longnan City, China from October 2015 to January 2018 were collected. All patients were diagnosed using CT and MRI.

The mean Lysholm Knee Scoring Scale score and mean International Knee Documentation Committee score were 51.43 ± 2.36 and 44.36 ± 2.24, respectively.[2] There were 32 males and 18 females aged 10 to 50 years (mean age, 20.46 ± 2.37 years). The disease duration was 1–400 days (mean disease duration, 125.68 ± 3.67 days). The causes of injury were sports (n = 6), traffic accidents (n = 37), and falls (n = 7).

Operative outcomes

The operation was successfully conducted in all 50 patients. The mean operation time was 60.23 ± 5.64 minutes and the mean intraoperative blood loss was 56.89 ± 3.68 mL. Delayed postoperative wound healing occurred in two patients; these patients were given mecobalamin tablets (GYZZ H20050997; Hainan STAR Pharmaceutical Co., Ltd., Qionghai, China), and recovered 1 month later. There were no cases of incision infection, sinus formation, or nerve injury.

Postoperative follow-up

A total of 50 patients were followed up for 6–40 months (mean follow-up duration, 30.2 ± 3.6 months). The mean knee range of motion significantly improved from 95.6 ± 5.8° preoperatively to 132.7 ± 4.5° 6 months postoperatively (P = 0.000). The Lysholm Knee Scoring Scale score and International Knee Documentation Committee score were significantly higher postoperatively compared with preoperatively (both P < 0.05). Detailed data are shown in [Table 4] and [Table 5].
Table 4: Comparison of Lysholm Knee Scoring Scale scores before and after open reduction and internal fixation with absorbable screws through a small incision

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Table 5: Comparison of International Knee Documentation Committee scores before and after open reduction and internal fixation with absorbable screws through a small incision

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Adverse events

Radiographic examination performed 3 months postoperatively revealed bone union in all cases, with no joint stiffness or fracture redisplacement [Table 6].
Table 6: Postoperative adverse reactions

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  Discussion Top


Limitations of this study

The limitations of this study are that there will be no control group, the groups will not be randomized or blinded, and the long-term efficacy during follow-up of more than 2 years will not be evaluated. The findings will need to be verified in future, multi-center, large-sample, randomized controlled trials.

Generalizability

This trial will verify the efficacy and safety of open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture. The findings will provide evidence for the selection of the best surgical treatment.

Explanation

Our pilot study results demonstrate good bone union on radiographic examination performed 3 months postoperatively, and good recovery of knee function at 6 months postoperatively. Delayed postoperative wound healing occurred in two patients. The preliminary results indicate that open reduction and internal fixation with absorbable screws through a small incision in the repair of anterior cruciate ligament tibial eminence avulsion fracture has the advantages of short operation time, less trauma than traditional open surgery, good functional recovery, and few complications.

Based on the relevant literature and our surgical experience, we consider that the following points should be noted in the treatment of anterior cruciate ligament tibial eminence avulsion fracture with internal fixation with absorbable screws through a small incision. (1) For anterior cruciate ligament tibial eminence avulsion fracture, the earlier the implementation, the better the outcome is. For patients with other platform fractures and ligament injuries, the timing of surgical intervention is not as crucial. (2) Care must be taken to protect the vascular nerve bundle and the triceps surae nerve branch intraoperatively. (3) The surgical incision must not be too high, so as to avoid excessively cutting the articular capsule.


  Data Authenticity Management Top


Data collection

All data from patients with anterior cruciate ligament tibial eminence avulsion fractures will be collected using case report forms, which will be signed and dated by the principle researcher.

Data management

Epi-Data 3.0 software will be used to establish the corresponding entry procedure and a database system dedicated to this self-controlled trial. Data will be inputted 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. The study will be conducted under the supervision of a qualified representative.

Modification of research plan

Other participating researchers may not modify the content of the protocol (such as the inclusion criteria and outcome measures) without the permission of the research leader during the trial.

Audits

Researchers will allow the inspector to review all case reports and test records during and after the study. The Independent Data Monitoring Committee will report the progress of the trial to the Ethics Committee every 2 months.

Confidentiality

Patients’ personal information will be kept strictly confidential.

Declaration of interest

None declared.

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.

Publication of results

Results 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.


  Trial Status Top


Registration time: March 13, 2019.

Data collection time and recruitment time: August 1, 2019–December 1, 2020.

Study completed: February 1, 2021.

Additional files

Additional file 1: Hospital Ethics Approval (Chinese).

Additional file 2: Informed Consent Form (Chinese).

Author contributions

Subject recruitment, data collection and analysis: XGY; study director: XGY and YZW. Both authors approved the final version of this manuscript.

Conflicts of interest

The authors have no conflicts of interest to declare.

Financial support

None.

Institutional review board statement

This study will be performed in strict accordance with the Decla-ration of Helsinki formulated by the World Medical Association. This study was approved by the Medical Ethics Committee of No. 1 Hospital of Longnan City, China in December 2014 (approval number: S2014-064-02).

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the forms, the patients have given 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.

Reporting statement

This study follows the Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals developed by the International Committee of Medical Journal Editors. Biostatistics statement

The statistical methods of this study were reviewed by the bio-statistician of No. 1 Hospital of Longnan City, China.

Copyright license agreement

The Copyright License Agreement has been signed by both 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.

Plagiarism check

Checked twice by iThenticate.

Peer review

Externally peer reviewed.

Open access statement

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribu-tion-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

C-Editor: Zhao M; S-Editors: Wang J, Li CH; L-Editors: Zammit K, Wysong S, Qiu Y, Wang L; T-Editor: Jia Y



 
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    Figures

  [Figure 1], [Figure 2]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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