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

Sponsor

Oslo University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03377205

Collaborator

Ostfold Hospital Trust (Other), Vestre Viken Hospital Trust (Other)

120

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Fractures	Device: Compression screws and neutralization plate Device: Acumed Fibular Rod System	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

American Orthopaedic Foot and Ankle Society (AOFAS) score [2 years]
Functional outcome as assessed by AOFAS score (0-100)

Secondary Outcome Measures

Manchester-Oxford Foot questionnaire (MOxFQ) [2 years]
Patient reported outcome as assessed by MOxFQ (0-100)
Olerud and Molander Score (OMS) [2 years]
Patient reported outcome as assessed by OMS (0-100)
EuroQol-5d (Eq-5d) [2 years]
Patient reported quality of life as assessed by Eq-5d index score
Visual analogue scale (VAS) [2 years]
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
Fracture reduction as assessed by CT scans [2 years]
Number of patients with good, fair or poor fracture reduction
Malunion as assessed by CT scans [2 years]
Number of patients with malunion
Nonunion as assessed by CT scans [2 years]
Number of patients with nonunion
Osteoarthritis as assessed by CT scans [2 years]
Number of patients with osteoarthritis assessed by The Kellgren and Lawrence grading system
Infection [3 months]
Number of patients with wound infection or deep infection
Delayed wound healing [3 months]
Number of patients with delayed wound healing
Other complications [2 years]
Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	0450

Sponsors and Collaborators

Oslo University Hospital
Ostfold Hospital Trust
Vestre Viken Hospital Trust

Investigators

Study Chair: Elisabeth E Husebye, MD, PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elisabeth Ellingsen Husebye, Principal investigator, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT03377205

Other Study ID Numbers:

2016/137 (REK)

First Posted:

Dec 19, 2017

Last Update Posted:

Mar 4, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Fractures, Bone

Ankle Fractures

Study Results

No Results Posted as of Mar 4, 2021