Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.

Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.

The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Fractures
• Intervention / Treatment: Device: Compression screws and neutralization plate; Device: Acumed Fibular Rod System

Detailed Description

Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
• Operable with both methods of surgery within 3 weeks after injury.
• Men and women ≥ 60 yoa.

Exclusion Criteria:

• Prior injury or pathology with reduced ankle function.
• Other acute foot/ankle/leg injury that will affect ankle function.
• Fracture of the posterior malleolus that need fixation.
• Injury / pathology that may affect rehabilitation.
• Open fracture.
• Inoperable patient.
• Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.

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: Plate; Compression screws and neutralization plate.	Device: Compression screws and neutralization plate; Open reduction and internal fixation with screws and plate
Experimental: Intramedullary nail; Acumed Fibular Rod System	Device: Acumed Fibular Rod System; intramedullary nailing of fibula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Orthopaedic Foot and Ankle Society (AOFAS) score	Functional outcome as assessed by AOFAS score (0-100)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection	Number of patients with wound infection or deep infection	3 months
Delayed wound healing	Number of patients with delayed wound healing	3 months
Manchester-Oxford Foot questionnaire (MOxFQ)	Patient reported outcome as assessed by MOxFQ (0-100)	5 years
Olerud and Molander Score (OMS)	Patient reported outcome as assessed by OMS (0-100)	5 years
EuroQol-5d (Eq-5d)	Patient reported quality of life as assessed by Eq-5d index score	5 years
Visual analogue scale (VAS)	VAS scores for pain during rest (0-10), during walking (0-10), at night (0-10), and during daily activities (0-10), where 10 is best	5 years
Fracture reduction as assessed by CT scans	Number of patients with good, fair or poor fracture reduction	3 months
Malunion as assessed by CT scans	Number of patients with malunion	5 years
Nonunion as assessed by CT scans	Number of patients with nonunion	5 years
Osteoarthritis as assessed by CT scans	Number of patients with osteoarthritis assessed according to the criteria by McLennan et al	5 years
Other complications	Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)	5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Vestre Viken Hospital Trust; Ostfold Hospital Trust
• Investigators: Study Chair: Elisabeth E Husebye, MD, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2021
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Ankle Injuries; Fractures, Bone; Ankle Fractures
• Other Study ID Numbers: 2016/137 (REK)

Plan for Individual participant data (IPD)

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