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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

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.

Condition or disease Intervention/treatment Phase
Tibial Shaft Fracture Procedure: Intramedullary Nailing Procedure: External Ring fixation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
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
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)
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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

  5. 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.

  6. Radiological alignment [ Time Frame: 6 weeks, 3+6+12 months ]
    Alignment of the tibia will be evaluated using the EOS scanning system.

  7. 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

  8. 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.

  9. Health economic evaluation [ Time Frame: 12 months ]
    Measure the cost of treatment in the two groups within the first year following surgery

  10. Gait assessment [ Time Frame: 3+6+12 months ]
    Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.

  11. 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

  12. 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.

  13. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945669


Contacts
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Contact: Rasmus Elsøe, PhD +4597660000 rae@rn.dk
Contact: Peter Larsen, PhD +4597660000 peter.larsen@rn.dk

Locations
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Denmark
Aalborg University Hospital, Department of orthopaedic surgery Recruiting
Aalborg, Denmark, 9000
Contact: Rasmus Elsøe, MD, PhD         
Sub-Investigator: Rasmus Stokholm, MD         
Sub-Investigator: Peter Larsen, PhD         
Sponsors and Collaborators
Aalborg University Hospital
Danish Council for Independent Research
Investigators
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Study Director: Rasmus Elsøe, PhD Aalborg University Hospital
Principal Investigator: Rasmus Stokholm, MD Aalborg University Hospital
Principal Investigator: Peter Larsen, PhD Aalborg University Hospital
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Responsible Party: Rasmus Elsøe, Head of Orthopaedic trauma, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03945669    
Other Study ID Numbers: LERG1
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rasmus Elsøe, Aalborg University Hospital:
External ring fixation
Intramedullary nailing
Tibial shaft fracture
patient reported outcome
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries