NCT04303663

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

March 8, 2020

Last Update Submit

March 7, 2022

Conditions

Ankle Fractures

Keywords

Fibular NailFibular RodFibular Plate

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Routine radiological parameters

    0 week

  • Routine radiological parameters

    6-weeks

  • Routine radiological parameters

    12-weeks

  • Routine radiological parameters

    26-weeks

Study Arms (2)

Fibular Plate

ACTIVE COMPARATOR

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

Fibular Nail

EXPERIMENTAL

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

Procedure: Fibular Nail

Interventions

Fibular PlatePROCEDURE

ORIF with Plating

Fibular Plate
Fibular NailPROCEDURE

CRIF +/- ORIF with Fibular nail

Fibular Nail

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 11011670BACKGROUND

  • 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.

    PMID: 11428758BACKGROUND

  • 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).

    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.

    PMID: 22844054BACKGROUND

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesAnkle InjuriesLeg Injuries

Study Officials

  • Samuel KK Ling, MBChB

    CUHK

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share