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

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ClinicalTrials.gov Identifier: NCT03945669
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborator:
Danish Council for Independent Research
Information provided by (Responsible Party):
Rasmus Elsøe, Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport) [ Time Frame: 12 month follow up ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • Perceived Pain [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
  • Muscle strength [ Time Frame: 6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Alignment of the tibia will be evaluated using the EOS scanning system.
  • Health related QOL [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Measure the time from surgery to end of sick leave measured in days.
  • Health economic evaluation [ Time Frame: 12 months ]
    Measure the cost of treatment in the two groups within the first year following surgery
  • Gait assessment [ Time Frame: 3+6+12 months ]
    Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
  • Patient Acceptable Symptom State (PASS) [ Time Frame: 3+6+12 months ]
    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) [ Time Frame: 6 weeks, 3+6+12 months ]
    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) [ Time Frame: 6 weeks, 3+6+12 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Perceived Pain [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Pain DETECT questionnaire.
  • Pain sensitivity [ Time Frame: 6 weeks, 3+6+12 months ]
    Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).
  • Muscle strength [ Time Frame: 6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Alignment of the tibia will be evaluated using the EOS scanning system.
  • Health related QOL [ Time Frame: 6 weeks, 3+6+12 months ]
    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 [ Time Frame: 6 weeks, 3+6+12 months ]
    Measure the time from surgery to end of sick leave measured in days.
  • Health economic evaluation [ Time Frame: 12 months ]
    Measure the cost of treatment in the two groups within the first year following surgery
  • Gait assessment [ Time Frame: 3+6+12 months ]
    Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.
  • Patient Acceptable Symptom State (PASS) [ Time Frame: 3+6+12 months ]
    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) [ Time Frame: 6 weeks, 3+6+12 months ]
    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) [ Time Frame: 6 weeks, 3+6+12 months ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: May 9, 2019)
Adverse events [ Time Frame: 6 weeks, 3+6+12 months ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Intramedullary Nailing vs External Ring Fixation for the Treatment of Tibial Shaft Fractures
Official Title  ICMJE 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)
Brief Summary This study is a 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study is a pragmatic assessor blinded randomized and prospective clinical trial.
Masking: Single (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.
Primary Purpose: Treatment
Condition  ICMJE Tibial Shaft Fracture
Intervention  ICMJE
  • Procedure: Intramedullary Nailing
    fracture fixation of the tibial shaft fracture with an intramedullary nail.
  • Procedure: External Ring fixation
    fracture fixation of the tibial shaft fracture with an external ring fixator.
Study Arms  ICMJE
  • 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 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.
    Intervention: Procedure: Intramedullary Nailing
  • 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.
    Intervention: Procedure: External Ring fixation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
152
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2024
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rasmus Elsøe, PhD +4597660000 rae@rn.dk
Contact: Peter Larsen, PhD +4597660000 peter.larsen@rn.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945669
Other Study ID Numbers  ICMJE LERG1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rasmus Elsøe, Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE Danish Council for Independent Research
Investigators  ICMJE
Study Director: Rasmus Elsøe, PhD Aalborg University Hospital
Principal Investigator: Rasmus Stokholm, MD Aalborg University Hospital
Principal Investigator: Peter Larsen, PhD Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP