Clinical trial NCT04303663: Fibular Nail vs Plate in Ankle Fractures
Official title: Randomised Controlled Trial to Compare the Efficacy of Fibular Nail Fixation vs Plate Fixation in Ankle Fracture Management
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Fractures
Keywords: Fibular Nail
Fibular Rod
Fibular Plate
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot Function
timeFrame: 12-week
measure: Foot Function
timeFrame: 26-week
Secondary outcomes:
measure: Routine radiological parameters
timeFrame: 0 week
measure: Routine radiological parameters
timeFrame: 6-weeks
measure: Routine radiological parameters
timeFrame: 12-weeks
measure: Routine radiological parameters
timeFrame: 26-weeks
Other outcomes:
Locations:
Study officials:
affiliation: CUHK
name: Samuel KK Ling, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salai M, Dudkiewicz I, Novikov I, Amit Y, Chechick A. The epidemic of ankle fractures in the elderly--is surgical treatment warranted? Arch Orthop Trauma Surg. 2000;120(9):511-3. doi: 10.1007/s004020000172.
citation: Pagliaro AJ, Michelson JD, Mizel MS. Results of operative fixation of unstable ankle fractures in geriatric patients. Foot Ankle Int. 2001 May;22(5):399-402. doi: 10.1177/107110070102200507.
citation: Appleton P, McQueen M, Court-Brown C. The Fibula Nail for Treatment of Ankle Fractures in Elderly and High Risk Patients. Tech Foot Ankle Surg [Internet]. 2006;5(3).
citation: Bugler KE, Watson CD, Hardie AR, Appleton P, McQueen MM, Court-Brown CM, White TO. The treatment of unstable fractures of the ankle using the Acumed fibular nail: development of a technique. J Bone Joint Surg Br. 2012 Aug;94(8):1107-12. doi: 10.1302/0301-620X.94B8.28620.