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Fibular Nail vs Plate in Ankle Fractures

Randomised Controlled Trial to Compare the Efficacy of Fibular Nail Fixation vs Plate Fixation in Ankle Fracture Management

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303663
Enrollment
0
Registered
2020-03-11
Start date
2022-01-01
Completion date
2024-12-31
Last updated
2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fractures

Keywords

Fibular Nail, Fibular Rod, Fibular Plate

Brief summary

Randomised Controlled Trial to Compare the Efficacy of Fibular Nail Fixation vs Plate Fixation in Ankle Fracture Management

Detailed description

Ankle fracture is a common injury with a wide spectrum of mechanism, especially in the elderly population. Surgical treatment of the unstable ankle fracture presents encouraging outcomes. Open reduction with plate osteosynthesis is the gold standard but is sometimes complicated by wound problems. The overall rate of complications after open reduction and internal fixation of ankle fracture varies from 5% to 40%. Wound complication, including superficial and deep ones, was reported as high as 18.8% in a previous meta-analysis, especially in the patients with high-risk factors e.g. elderly, osteoarthritis and diabetic subpopulation. Newer implants such as locked fibular nail (FN) have been developed with studies showing promising results. The Acumed fibular rod system is such an alternative method which is a metallic implant with length 110mm, 145 mm and 180 mm. The shorter diameter of the nail (ranging from 3.0 mm-3.6 mm) allows surgeons to make an incision as short as 1 cm compared to the 8-cm incision in conventional lateral plate fixation. Also, it shows advantages in mechanical stability for osteoporotic bone with less prominent metalwork. The nail is anchored by a lateral-medial locking screw at the level of the syndesmosis and two anterior-posterior locking screws distally. A 1-cm longitudinal incision will be made over the tip of the lateral malleolus after performing a closed reduction. The results from previous studies imply that the fibular rod system may give positive outcomes. However, the majority of the relative studies were single-centre series providing a low level of evidence and lacking a comparative group. For example, a case series retrospectively reviewed 105 patients who experienced surgical treatment using the Acumed fibular rod system for ankle fracture and found good functional and radiographic results with minimal complications. Like all other retrospective studies, the follow up was not complete and some radiographic information could not be obtained. Thus a comparative study with a high level of evidence is required to provide more information for surgeons. To the investigators' best knowledge, no prospective randomized controlled trials have been conducted to investigate the clinical outcomes and radiographic results after surgical treatment using the Acumed fibular rod system in ankle fracture. The objective of the study is to compare the clinical outcomes of locking fibular nail and to results of the open-reduction with plate fixation in ankle fracture management.

Interventions

PROCEDUREFibular Plate

ORIF with Plating

PROCEDUREFibular Nail

CRIF +/- ORIF with Fibular nail

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with minimally displaced fibular fracture * Type A or type B according to Weber ankle fracture classification * Be able to walk without assistance in pre-injury status

Exclusion criteria

* Medical co-morbidity that prevents the patient from undergoing surgery * Surgery delayed for \>2-weeks after the initial injury * Pre-existing/old injury in the ipsilateral limb * Severe physical, mental disability that renders the participant unable to conform to usual rehabilitation regimes (Recent lower limb surgery, pre-existing neurological problem and etc.) * Incapable to understand the study protocol or provide written informed consent

Design outcomes

Primary

MeasureTime frameDescription
Foot Function12-weekFoot and Ankle Outcome Score split into 5 categories: symptoms, pain, ADL, recreation, QOL. 0-100 with 0=severe symptoms and 100=no symptoms.

Secondary

MeasureTime frameDescription
Routine radiological parameters0 weekStandard ankle X-Ray from the anterior-posterior (AP) and lateral projection will be taken. medial and tibiotalar clear space and the talocrural angle will be measured.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026