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NCT Number: NCT03945669

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Department of orthopaedic surgery, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intramedullary nailing

Procedure

fracture fixation of the tibial shaft fracture with an intramedullary nail.

External Ring fixation

Procedure

fracture fixation of the tibial shaft fracture with an external ring fixator.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Danish Council for Independent Research

Registry information

Official study 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)

Acronym: IMVEX

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
May 10, 2019
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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