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

Ankle Fractures Clinical Trial

Official title:

Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03377205
• Other study ID #: 2016/137 (REK)
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2026

Study information

• Verified date: July 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: January 2026
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Device:
• Compression screws and neutralization plate
Open reduction and internal fixation with screws and plate
• Acumed Fibular Rod System
intramedullary nailing of fibula

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Ostfold Hospital Trust, Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Orthopaedic Foot and Ankle Society (AOFAS) score	Functional outcome as assessed by AOFAS score (0-100)	5 years
Secondary	Manchester-Oxford Foot questionnaire (MOxFQ)	Patient reported outcome as assessed by MOxFQ (0-100)	5 years
Secondary	Olerud and Molander Score (OMS)	Patient reported outcome as assessed by OMS (0-100)	5 years
Secondary	EuroQol-5d (Eq-5d)	Patient reported quality of life as assessed by Eq-5d index score	5 years
Secondary	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
Secondary	Fracture reduction as assessed by CT scans	Number of patients with good, fair or poor fracture reduction	3 months
Secondary	Malunion as assessed by CT scans	Number of patients with malunion	5 years
Secondary	Nonunion as assessed by CT scans	Number of patients with nonunion	5 years
Secondary	Osteoarthritis as assessed by CT scans	Number of patients with osteoarthritis assessed according to the criteria by McLennan et al	5 years
Secondary	Infection	Number of patients with wound infection or deep infection	3 months
Secondary	Delayed wound healing	Number of patients with delayed wound healing	3 months
Secondary	Other complications	Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)	5 years