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

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

Study Overview

• Status: Withdrawn
• Conditions: Ankle Fractures
• Intervention / Treatment: Procedure: Fibular Plate; Procedure: Fibular Nail

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fibular Plate; Open reduction and internal fixation of the fibular fracture Fixation of the fibular will be performed with a fibular plate +/- lag screws as judged intraoperatively	Procedure: Fibular Plate; ORIF with Plating
Experimental: Fibular Nail; Percutaneous or mini-open reduction of the fibular fracture and fixation with a fibular nail.	Procedure: Fibular Nail; CRIF +/- ORIF with Fibular nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function	Foot and Ankle Outcome Score split into 5 categories: symptoms, pain, ADL, recreation, QOL. 0-100 with 0=severe symptoms and 100=no symptoms.	12-week
Foot Function	Foot and Ankle Outcome Score split into 5 categories: symptoms, pain, ADL, recreation, QOL. 0-100 with 0=severe symptoms and 100=no symptoms.	26-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine radiological parameters	Standard 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.	0 week
Routine radiological parameters	Standard 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.	6-weeks
Routine radiological parameters	Standard 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.	12-weeks
Routine radiological parameters	Standard 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.	26-weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Samuel KK Ling, MBChB, CUHK

Publications and helpful links

General Publications

• 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.
• 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.
• 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).
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 8, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fibular Nail; Fibular Rod; Fibular Plate
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: CUHK_fibularnail

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No