Status Approved
First Submitted Date
2020/02/21
Registered Date
2020/02/25
Last Updated Date
2020/02/21
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004768 |
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Unique Protocol ID | WKUH 201910004005 |
Public/Brief Title | The comparison of outcomes between the fibular nail versus open reduction and internal fixation for lateral malleolar fracture |
Scientific Title | The comparison of clinical and radiologic outcomes between the fibular nail versus standard open reduction and internal fixation for fixation of lateral malleolar fracture: Prospective randomized controlled study. |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | WKUH 201910004005 |
Approval Date | 2020-02-05 |
Institutional Review Board Name | Wonkwang University Hospital Institutional Review Board |
Institutional Review Board Address | 895, Muwang-ro, Iksan-si, Jeollabuk-do |
Institutional Review Board Telephone | 063-859-2232 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Sung Hyun Lee |
Title | Assisted Professor |
Telephone | +82-63-268-1360 |
Affiliation | Wonkwang University Hospital |
Address | Wonkwang University Hospital Institutional Review Board |
Contact Person for Public Queries | |
Name | Sung Hyun Lee |
Title | Assisted Professor |
Telephone | +82-63-268-1360 |
Affiliation | Wonkwang University Hospital |
Address | Wonkwang University Hospital Institutional Review Board |
Contact Person for Updating Information | |
Name | Sung Hyun Lee |
Title | Assisted Professor |
Telephone | +82-63-268-1360 |
Affiliation | Wonkwang University Hospital |
Address | Wonkwang University Hospital Institutional Review Board |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-02-06 Actual | |
Target Number of Participant | 60 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Wonkwang University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-02-06 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Wonkwang University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Wonkwang University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Ankle fracture was first introduced by Sir Percival Pott in 1768 and is one of the most commonly observed bone damages. The prevalence of ankle fractures has also increased as the number of osteoporosis patients has increased as the age of aging. The most commonly accepted fracture classification systems are the "Danis-Weber" system and the "Lauge-Hansen" system. Both classification systems have classified and defined fractures to manage these damages on the basis of stability related to the degree of dislocation, whether or not the medial part is damaged and whether the bone has been displaced. Fracture treatment aims to reduction displaced fractures, maintain anatomical alignment on radiological examinations, and achieve bone union. The open reduction and internal fixation is generally fixed through metal plates and screws in accordance with AO principle. In unstable ankle fractures, open reduction and internal fixation through plate and screw are common, but since the 1960s, plate development has been minimal. The fixation with plate and screw is associated with a number of complications. Extensive incisions and exfoliation of soft tissues over the bones are essential for exposing fractures, leaving vulnerable wounds. Wound dehiscence and infections are reported up to 25%, especially in people with diabetes and neuropathy or in older people. The cost of treating these complications can be more expensive and the long-term follow-up results are usually poor. Thin soft tissue on the plate may delay wound healing and may eventually require additional plate removal in 50% of patients whose wounds are not healed. Placing a metal plate behind the fibula can reduce wound-related complications but can cause irritation of the peroneal tendon. Mechanical failure of fixation occurs up to 14%, especially in the presence of osteoporosis, and the pull-out is common with loose screws. A study of open reduction and internal fixation in 1,822 patients with ankle fractures showed unsatisfactory results in functional, clinical and radiological follow-up in one-fifth patients. Fibula intramedullary nailing has been developed by Bugler et al., and fibula intramedullary nailing can avoid the above complications and thus improve clinical and radiological results. Representative features include reduction of incision size and axial holding force of the metal. According to a Kadeba study, the fibula nail can withstand higher loads than conventional metal plates and screws. However, the number of screws to be fixed is relatively small compared to the metal plate, so the fixing force may be weak for a particular bone fragment according to the fracture pattern and the number of screws that bear the load applied to the weight load is small, so the stress transmitted to each screw is exceeded. Screw loosening and pull-out are known complications. According to a study of 50 patients who underwent intramedullary nailing, a locking screw was released in 10% of the patients and an additional screw was removed. After that, one patient who had lost anatomical reduction was reoperated with internal fixation using a plate after removal of the nail. In the future, further studies on the two representative surgical methods should be developed to become more effective treatments. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject, Outcome Accessor |
Allocation | RCT |
Intervention Type | /Procedure/Surgery |
Intervention Description | We performed an open reduction and internal fixation or a closed reduction and intramedullart nail fixation for lateral malleolus fractures. |
Number of Arms | 2 |
Arm 1 |
Arm Label Open reduction and internal fixation group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description We performed an open reduction and internal fixation for lateral malleolar fracture. |
|
Arm 2 |
Arm Label intramedullart nail fixation group |
Target Number of Participant 30 |
|
Arm Type Experimental |
|
Arm Description We performed a closed reduction and intramedullart nail fixation for lateral malleolus fractures. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (S00-T98)Injury, poisoning and certain other consequences of external causes (S82.880)Fracture of other parts of lower leg, closed ankle fracture |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description (1) patients with displaced lateral malleolar fractures of ankle joint (2) Patients who agreed to treatment method and postoperative examination (3) Patients who can have CT scan before and after surgery (4) Patients who are expected to be able to follow up for more than one year (5) Patients who agreed to the agreement |
|
Exclusion Criteria |
(1) open ankle fracture (2) past fractures in the affected foot and ankle joint (3) Past surgical history of affected foot and ankle (4) alteration of ankle alignment due to arthritis, congenital diseases, etc. (5) History of other musculoskeletal and nervous system diseases |
Healthy Volunteers |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Foot and Ankle Outcome Score |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
|
Secondary Outcome(s) 1 | ||
Outcome | Presence of posttraumatic arthritis |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
|
Secondary Outcome(s) 2 | ||
Outcome | Visual analogue scale |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
|
Secondary Outcome(s) 3 | ||
Outcome | American Orthopedic foot and ankle score |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
|
Secondary Outcome(s) 4 | ||
Outcome | Karlsson Score |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
|
Secondary Outcome(s) 5 | ||
Outcome | Tegner Activity Scales |
|
Timepoint | Postoperative 3months, 6months, 1year and yearly |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2023. 12 |
Way of Sharing | Available on Request
(kensin06@hanmail.net) |
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