Fibular Nail vs Plate in Ankle Fractures

NCT ID: NCT04303663

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Fibular Plate

Intervention Type: PROCEDURE

ORIF with Plating

Fibular Nail

Percutaneous or mini-open reduction of the fibular fracture and fixation with a fibular nail.

Group Type: EXPERIMENTAL

Fibular Nail

Intervention Type: PROCEDURE

CRIF +/- ORIF with Fibular nail

Interventions

Fibular Plate

ORIF with Plating

Intervention Type: PROCEDURE

Fibular Nail

CRIF +/- ORIF with Fibular nail

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Samuel KK Ling

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel KK Ling, MBChB

Role: PRINCIPAL_INVESTIGATOR

CUHK

References

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.

Reference Type: BACKGROUND

PMID: 11011670 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11428758 (View on PubMed)

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).

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 22844054 (View on PubMed)

Other Identifiers

CUHK_fibularnail

Identifier Type: -

Identifier Source: org_study_id