AzTrials
AzTrials

Tibial Shaft FractureIMVEXNCT03945669

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

A study testing Intramedullary Nailing and External Ring fixation in people with Tibial Shaft Fracture, run by Aalborg University Hospital at 3 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tibial Shaft Fracture
What is being tested?
Intramedullary Nailing and External Ring fixation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
3 sitesDenmark
Study dates
1 Nov 2019to 24 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Denmark3 sites

  • Aalborg University Hospital, Department of orthopaedic surgery

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8000

  • Regional Hospital Viborg

    Viborg, 8800

Other trials in Denmark

About this study

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)

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.

Read the 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.

Being tested
Intramedullary Nailing, External Ring fixation
Keywords
External ring fixation, Intramedullary nailing, Tibial shaft fracture, patient reported outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intramedullary NailingProcedure or surgery

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

  • External Ring fixationProcedure or surgery

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

Study groups in NCT03945669
Study groupRoleWhat they receive
Intramedullary NailActive comparatorIntramedullary 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.
Receives: Procedure: Intramedullary Nailing
External Ring fixatorExperimentalExternal 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.
Receives: Procedure: External Ring fixation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 month follow up

Secondary outcomes (13)

  1. 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.

    Measured: 6 weeks, 3+6+12 months

  2. 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.

    Measured: 6 weeks, 3+6+12 months

  3. Pain sensitivity

    Pain sensitivity will be assessed by pressure pain thresholds (PPTs) recorded by handheld pressure algometry (Algometer Type II, Somedic AB, Sweden).

    Measured: 6 weeks, 3+6+12 months

  4. 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

    Measured: 6+12 months

  5. 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.

    Measured: 6 weeks, 3+6+12 months

  6. Radiological alignment

    Alignment of the tibia will be evaluated using the EOS scanning system.

    Measured: 6 weeks, 3+6+12 months

  7. 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

    Measured: 6 weeks, 3+6+12 months

  8. Time to return to work

    Measure the time from surgery to end of sick leave measured in days.

    Measured: 6 weeks, 3+6+12 months

  9. Health economic evaluation

    Measure the cost of treatment in the two groups within the first year following surgery

    Measured: 12 months

  10. Gait assessment

    Gait asymmetries will be measured with patients walking on a pressure-sensitive mat.

    Measured: 3+6+12 months

  11. 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

    Measured: 3+6+12 months

  12. 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.

    Measured: 6 weeks, 3+6+12 months

  13. 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.

    Measured: 6 weeks, 3+6+12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2019
  2. Study start1 Nov 2019
  3. Primary completion24 Jun 2024
  4. Study completion24 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a multicenter pragmatic assessor blinded randomized and prospective clinical trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03945669
Sponsor's protocol ID
LERG1
Acronym
IMVEX
Status last verified
Jun 2024
First submitted
3 May 2019
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Larsen P, Stokholm R, Rolfing JD, Petruskevicius J, Rasmussen MK, Jensen SS, Elsoe R. Intramedullary nailing versus external ring fixation for tibial shaft fractures: an explorative analysis of muscle strength from the IMVEX trial. Arch Orthop Trauma Surg. 2025 Jul 18;145(1):379. doi: 10.1007/s00402-025-05995-6.

    PubMed 40679543

Questions about this trial

What is this clinical trial studying?

A study testing Intramedullary Nailing and External Ring fixation in people with Tibial Shaft Fracture, run by Aalborg University Hospital at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Knee Injury and Osteoarthritis Outcome Score - sport (KOOS Sport) (time frame: 12 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03945669, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in