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Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures (IMVEX)

Primary Purpose

Tibial Shaft Fracture

Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intramedullary Nailing
External Ring fixation
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Shaft Fracture focused on measuring External ring fixation, Intramedullary nailing, Tibial shaft fracture, patient reported outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fracture of the tibial shaft
  • OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3
  • The fracture type is deemed operable by intramedullary nail

Exclusion Criteria:

  • Below 18 years of age
  • Open fracture
  • History of severe systemic diseases or cancer
  • Bilateral tibial shaft fracture
  • Multi fracture patients
  • Pregnancy
  • Patients without gait function prior to fracture

Sites / Locations

  • Aalborg University Hospital, Department of orthopaedic surgery
  • Aarhus University Hospital
  • Regional Hospital Viborg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intramedullary Nail

External Ring fixator

Arm Description

Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.

External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.

Outcomes

Primary Outcome Measures

The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

Secondary Outcome Measures

Perceived Pain
Development in pain in the two groups will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.
Patient-reported pain reactions
Pain DETECT questionnaire. The painDETECT screening questionnaire (PD-Q), uses a scoring method between - 1 and 38 to estimate the likelihood of a neuropathic pain component in patients.
Pain sensitivity
Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
Muscle strength
Isometric muscle strength in the two groups will be measured by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK). Girth measures of thigh and calf will be used to examine muscle atrophy and/or effusion
Time to bone union
Bone union, in the two surgical groups will be evaluated on standard AP and side X-rays of the fractured leg. The evaluation of bone union will be defined as: i) visible callus formation on at least three of four sides, no visible fracture line and no pain from fracture site at weight-bearing and during clinical examination.
Radiological alignment
Alignment of the tibia will be evaluated using the EOS scanning system.
Health related QOL
Eq5D-5L is a standardized questionnaire developed to assess general health outcome (29). It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death
Time to return to work
Measure the time from surgery to end of sick leave measured in days.
Health economic evaluation
Measure the cost of treatment in the two groups within the first year following surgery
Gait assessment
Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
Patient Acceptable Symptom State (PASS)
This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems.The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Foot And Ankle Outcome Score (FAOS)
FAOS is a standardized and validated patient-reported instrument used in order to assess foot and ankle associated problems divided into 5 subscales. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.

Full Information

First Posted
May 3, 2019
Last Updated
June 19, 2023
Sponsor
Aalborg University Hospital
Collaborators
Danish Council for Independent Research
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1. Study Identification

Unique Protocol Identification Number
NCT03945669
Brief Title
Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures
Acronym
IMVEX
Official Title
Intramedullary Nailing Versus External Ring Fixation for Surgical Treatment of Tibial Shaft Fractures in Adults and Their One Year Outcome on Recovery: Study Protocol for a Pragmatic Randomized Controlled Trial (The IMVEX Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital
Collaborators
Danish Council for Independent Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures.
Detailed Description
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial in which standard intramedullary nailing is compared with external ring fixator for patients with tibial shaft fractures. The primary aim of the project is to compare the one-year Knee Injury and Osteoarthritis Outcome Score - Sport (KOOS-Sport) after standard intramedullary nailing with external ring fixation for patients with tibial shaft fractures. The explorative aim is to report the effect of the two surgical procedures on the development of complications, time to bone union, pain reactions, muscle strength, activity of daily living and time to return to work.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Shaft Fracture
Keywords
External ring fixation, Intramedullary nailing, Tibial shaft fracture, patient reported outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.
Masking
Outcomes Assessor
Masking Description
Due to the nature of the study participants, care providers and investigator can not be blinded. The outcome assessor will be blinded with regards to the two treatment groups.
Allocation
Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intramedullary Nail
Arm Type
Active Comparator
Arm Description
Intramedullary Nailing: Alignment will be obtained by closed or limited open reduction of the fracture. A standard reamed intramedullary nail is inserted. Access above the patella, through the patella tendon or parapatellar access is used according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. Patients are administered preoperative antibiotics (Dicloxacillin) 15 minutes before surgery commences. Postoperative antibiotics is administered by discretion of the surgeon based on individual patient considerations.
Arm Title
External Ring fixator
Arm Type
Experimental
Arm Description
External Ring fixation: Closed or limited open reduction of the fracture is performed. A circular frame is attached on both sides of the fracture. Connection to the bone is obtained by hydroxyapatite coated half pins and/or k-wires with olives as needed according to surgeon preferences. One or more cortical screws may be used if deemed appropriate due to fracture pattern. After applying the ring fixator alignment is assessed radiologically and corrected both peri- and postoperatively. Patients are administered preoperative antibiotics (Dicloxacillin) preoperatively 15 minutes before surgery commences. Following surgery antibiotics are continued until wounds, pin- and wire perforations are dry.
Intervention Type
Procedure
Intervention Name(s)
Intramedullary Nailing
Intervention Description
fracture fixation of the tibial shaft fracture with an intramedullary nail.
Intervention Type
Procedure
Intervention Name(s)
External Ring fixation
Intervention Description
fracture fixation of the tibial shaft fracture with an external ring fixator.
Primary Outcome Measure Information:
Title
The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport)
Description
KOOS-sport is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems with regards to activity. The subscale sport is one five subscales: pain, ADL, symptoms, sport and QOL in the KOOS questionnaire . A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time Frame
12 month follow up
Secondary Outcome Measure Information:
Title
Perceived Pain
Description
Development in pain in the two groups will be recorded by patient-reported pain intensity measured on a 10 cm visual analogue scale (VAS) with endpoints "no pain" and "maximal pain" for the worst pain during the last 24 hours and resting pain.
Time Frame
6 weeks, 3+6+12 months
Title
Patient-reported pain reactions
Description
Pain DETECT questionnaire. The painDETECT screening questionnaire (PD-Q), uses a scoring method between - 1 and 38 to estimate the likelihood of a neuropathic pain component in patients.
Time Frame
6 weeks, 3+6+12 months
Title
Pain sensitivity
Description
Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
Time Frame
6 weeks, 3+6+12 months
Title
Muscle strength
Description
Isometric muscle strength in the two groups will be measured by a strap-mounted dynamometer attached to the wall (Mecmesin AFG2500, Mecmesin Ltd, West Sussex, UK). Girth measures of thigh and calf will be used to examine muscle atrophy and/or effusion
Time Frame
6+12 months
Title
Time to bone union
Description
Bone union, in the two surgical groups will be evaluated on standard AP and side X-rays of the fractured leg. The evaluation of bone union will be defined as: i) visible callus formation on at least three of four sides, no visible fracture line and no pain from fracture site at weight-bearing and during clinical examination.
Time Frame
6 weeks, 3+6+12 months
Title
Radiological alignment
Description
Alignment of the tibia will be evaluated using the EOS scanning system.
Time Frame
6 weeks, 3+6+12 months
Title
Health related QOL
Description
Eq5D-5L is a standardized questionnaire developed to assess general health outcome (29). It consists of five dimensions: Mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and a self-rated health scale on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. An Eq5d-5L index of 1.0 indicated full health, 0 death, and -0.59 denoted a condition worse than death
Time Frame
6 weeks, 3+6+12 months
Title
Time to return to work
Description
Measure the time from surgery to end of sick leave measured in days.
Time Frame
6 weeks, 3+6+12 months
Title
Health economic evaluation
Description
Measure the cost of treatment in the two groups within the first year following surgery
Time Frame
12 months
Title
Gait assessment
Description
Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
Time Frame
3+6+12 months
Title
Patient Acceptable Symptom State (PASS)
Description
This instrument evaluate when the patient reaches a acceptable patient observed pain and function level, where the patient no longer demands treatment
Time Frame
3+6+12 months
Title
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
KOOS is a standardized and validated patient-reported instrument used in order to assess knee and knee associated problems.The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time Frame
6 weeks, 3+6+12 months
Title
Foot And Ankle Outcome Score (FAOS)
Description
FAOS is a standardized and validated patient-reported instrument used in order to assess foot and ankle associated problems divided into 5 subscales. The questionnaire includes five subscales: pain, ADL, symptoms, sport and QOL. A total score of 100 indicates no symptoms, and 0 indicates major symptoms.
Time Frame
6 weeks, 3+6+12 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events, defined as any negative or unwanted reactions to the two surgical procedures, will be recorded. These will include deep infection, pin infection, skin infections, malalignment, compartment syndrome or any other reported physical discomfort. An adverse effects committee will manage adverse reactions at the time of the adverse reaction.
Time Frame
6 weeks, 3+6+12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fracture of the tibial shaft OTA classification Type: 42-A1-A3, -B1-B3 and -C1-C3 The fracture type is deemed operable by intramedullary nail Exclusion Criteria: Below 18 years of age Open fracture History of severe systemic diseases or cancer Bilateral tibial shaft fracture Multi fracture patients Pregnancy Patients without gait function prior to fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus Elsøe, PhD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rasmus Stokholm, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Larsen, PhD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital, Department of orthopaedic surgery
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Regional Hospital Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures

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