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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Tibial Shaft Fracture
• Intervention / Treatment: Procedure: Intramedullary Nailing; Procedure: External Ring fixation

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.

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rasmus Elsøe, PhD; Phone Number: +4597660000; Email: rae@rn.dk
• Study Contact Backup: Name: Peter Larsen, PhD; Phone Number: +4597660000; Email: peter.larsen@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital, Department of orthopaedic surgery
  • Aarhus, Denmark, 8000
    • Aarhus University hospital
  • Viborg, Denmark, 8800
    • Regional Hospital Viborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intramedullary Nail; 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.	Procedure: Intramedullary Nailing; fracture fixation of the tibial shaft fracture with an intramedullary nail.
Experimental: External Ring fixator; 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.	Procedure: External Ring fixation; fracture fixation of the tibial shaft fracture with an external ring fixator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks, 3+6+12 months
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.	6 weeks, 3+6+12 months
Pain sensitivity	Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).	6 weeks, 3+6+12 months
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	6+12 months
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.	6 weeks, 3+6+12 months
Radiological alignment	Alignment of the tibia will be evaluated using the EOS scanning system.	6 weeks, 3+6+12 months
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	6 weeks, 3+6+12 months
Time to return to work	Measure the time from surgery to end of sick leave measured in days.	6 weeks, 3+6+12 months
Health economic evaluation	Measure the cost of treatment in the two groups within the first year following surgery	12 months
Gait assessment	Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.	3+6+12 months
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	3+6+12 months
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.	6 weeks, 3+6+12 months
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.	6 weeks, 3+6+12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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.	6 weeks, 3+6+12 months

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Danish Council for Independent Research
• Investigators: Study Director: Rasmus Elsøe, PhD, Aalborg University Hospital; Principal Investigator: Rasmus Stokholm, MD, Aalborg University Hospital; Principal Investigator: Peter Larsen, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: patient reported outcome; External ring fixation; Intramedullary nailing; Tibial shaft fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: LERG1

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No