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

Primary Purpose

Ankle Fractures

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Compression screws and neutralization plate
Acumed Fibular Rod System
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Fractures

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Plate

Intramedullary nail

Arm Description

Compression screws and neutralization plate.

Acumed Fibular Rod System

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2017
Last Updated
July 11, 2023
Sponsor
Oslo University Hospital
Collaborators
Ostfold Hospital Trust, Vestre Viken Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03377205
Brief Title
Intramedullary Nailing Versus Plate Fixation of Ankle Fractures. A Prospective, Randomized Controlled Trial.
Official Title
Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Ostfold Hospital Trust, Vestre Viken Hospital Trust

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plate
Arm Type
Active Comparator
Arm Description
Compression screws and neutralization plate.
Arm Title
Intramedullary nail
Arm Type
Experimental
Arm Description
Acumed Fibular Rod System
Intervention Type
Device
Intervention Name(s)
Compression screws and neutralization plate
Intervention Description
Open reduction and internal fixation with screws and plate
Intervention Type
Device
Intervention Name(s)
Acumed Fibular Rod System
Intervention Description
intramedullary nailing of fibula
Primary Outcome Measure Information:
Title
American Orthopaedic Foot and Ankle Society (AOFAS) score
Description
Functional outcome as assessed by AOFAS score (0-100)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Manchester-Oxford Foot questionnaire (MOxFQ)
Description
Patient reported outcome as assessed by MOxFQ (0-100)
Time Frame
5 years
Title
Olerud and Molander Score (OMS)
Description
Patient reported outcome as assessed by OMS (0-100)
Time Frame
5 years
Title
EuroQol-5d (Eq-5d)
Description
Patient reported quality of life as assessed by Eq-5d index score
Time Frame
5 years
Title
Visual analogue scale (VAS)
Description
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
Time Frame
5 years
Title
Fracture reduction as assessed by CT scans
Description
Number of patients with good, fair or poor fracture reduction
Time Frame
3 months
Title
Malunion as assessed by CT scans
Description
Number of patients with malunion
Time Frame
5 years
Title
Nonunion as assessed by CT scans
Description
Number of patients with nonunion
Time Frame
5 years
Title
Osteoarthritis as assessed by CT scans
Description
Number of patients with osteoarthritis assessed according to the criteria by McLennan et al
Time Frame
5 years
Title
Infection
Description
Number of patients with wound infection or deep infection
Time Frame
3 months
Title
Delayed wound healing
Description
Number of patients with delayed wound healing
Time Frame
3 months
Title
Other complications
Description
Number of patients with other complications (e.g. hardware complications, tromboemolism, neurologic complications, peroneus tendon irritation)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth E Husebye, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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

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