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Tibial FracturesNAFTINCT03388879

Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

A study testing Taylor Spatial Frame and Intramedullary nail in people with Tibial Fractures, run by Oslo University Hospital at 1 site in Norway.

Completed

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

Official record
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Trial summary

This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Tibial Fractures
What is being tested?
Taylor Spatial Frame and Intramedullary nail
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteNorway
Study dates
31 Oct 2010to 21 Jun 2016
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Closed tibia shaft fractures suited for both study treatments.
  • A patient who is informed of the purpose of the investigation and who has given informed consent and willingness to accept randomisation either to Taylor Spatial Frame or intramedullary nailing.
  • Willingness and ability to comply with all investigation procedures
  • Age between 18 to 70 years
  • Skeletally mature
  • Previous unaided walking

Who cannot join

  • Participation in other clinical investigations that will interfere with this study
  • Mental illness or other conditions that preclude ring fixator in the judgment of the investigator
  • Any other concurrent condition(s) that, in the judgment of the investigator, would prohibit the patient from participation in the study
  • No other injury or previous disease that would be likely to seriously influence the long term outcome (this will exclude e.g. osteomyelitis, vascular or neurological disorder of the lower extremities, rheumatoid artist, malignancy that could influence on bone healing)
  • Compartment syndrome before randomisation
  • Pathologic fracture
  • Ongoing or previous use the last year of drugs that can be bone anabolic (e.g. anabolic steroids, growth hormone, parathyroid hormone)

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Orthopedic Center, Ulleval University Hospital

    Oslo, 0408

Other trials in Norway

About this study

This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury. Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith \& Nephew, England) or a reamed intramedullar nail (according to local choice) with locking screws. Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36) after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications, healing, malunion, and resource use.

Read the detailed description

Fractures of the lower leg (fractures of the tibia shaft with or without concurrent fracture of the fibula) are a common injury. According to our fracture register 95 patients with closed tibia fractures were operated the last 3 years at our department. Fractures with moderate or no displacement can be successfully treated with a cast and subsequent Sarmiento brace. Displaced fractures are commonly treated with an intramedullary nail. Intramedullary nailing yields a high rate of union. More than 50 % of operated patients do, however, develop chronic anterior knee pain and one third of the patients have pain at rest. This contributes a big problem for many patients both at spare time and at work. Another problem is significant rates of malunion.

The use of ring fixators utilizing rings and 1,8 mm. wires was introduced by Gavril Ilizarov more than 50 years ago, and the technique has been further developed through the introduction of six adjustable struts (Taylor Spatial Frame). This hexapod circular frame allows accurate reduction as well as a high stability. The ring fixator is less invasive and allows early weight bearing, but may be cumbersome to the patient. There is also concern about pin-tract infection, osteomyelitis and joint contracture.

Only one prior study has compared ring fixator (Ilizarov) and intramedullar nail in closed tibia fractures. The results showed significant less anterior knee pain in the patients operated with ring fixator, but the study design did not allow clear conclusion.

Being tested
Taylor Spatial Frame, Intramedullary nail
Medical subject headings
Tibial Fractures

What participants receive

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

  • Taylor Spatial FrameDevice

    Also called Circular frame

    Circular external fixator

  • Intramedullary nailDevice

    Antegrade intramedullary nail

Study groups in NCT03388879
Study groupRoleWhat they receive
Circular frame external fixatorExperimentalA Taylor Spatial Frame should consist of 2 rings with 4 half pins/K-wire attached to each ring. If possible 3, not hydroxyapatite-coated, half pins and one K-wire should be attached to each ring. The half pins/K-wire should be spread in distance and direction for optimum stability.
Receives: Device: Taylor Spatial Frame
Intramedullary nailActive comparatorNailing technique according to Karladani and Styf published technique (ref: Karladani AH, Styf J. Percutaneous intramedullary nailing of tibial shaft fratures: a new approach for prevention of anterior knee pain. Injury, Int. J. Care Injury 32 (2001) 736-39)
Receives: Device: Intramedullary nail

What is being measured

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

  1. Physical Component summary of RAND SF 36 (Short Form 36)

    Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.

    Measured: 24 months

Secondary outcomes (21)

  1. Vitality Subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  2. Physical functioning, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  3. Bodily pain, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  4. General health perceptions, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  5. Physical role functioning, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  6. Emotional role functioning, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  7. Social role functioning, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  8. Mental health, subscore of RAND (SF) 36

    Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).

    Measured: 6, 12, 24 months

  9. Physical Component summary of RAND (SF) 36

    Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.

    Measured: 6, 12 months

  10. Pain around the knee

    VAS scale 0-10

    Measured: 6, 12, 24 months

  11. Pain around the fracture site

    VAS scale 0-10

    Measured: 6, 12, 24 months

  12. Pain around the ankle

    VAS scale 0-10

    Measured: 6, 12, 24 months

  13. Complications major (composite)

    Compartment syndrome, sequela compartment syndrome (e.g. short foot, clawing, neurological disorder), infection that needs operation, any unexpected reoperation (except removal of single pins or screws)

    Measured: 24 months

  14. Complications minor (composite)

    pin tract infection that needs antibiotics, wound complication that don't need reoperation, unexpected minor reoperations (i.e. removal of single pins or screws)

    Measured: 24 months

  15. Reoperations minor (composite)

    Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)

    Measured: 6, 12, 24 months

  16. Reoperations major (composite)

    Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)

    Measured: 6, 12, 24 months

  17. Time to union (composite)

    Time to fracture union in days. We require both radiographical union defined by callus bridging 3 of 4 cortices AND clinical union defined by full, pain free and unaided weight bearing.

    Measured: 6, 12, 24 months

  18. Resource use; Away from work

    Number of days away from work for employed patients

    Measured: 24 months

  19. Resource use; Emergency contacts

    Number of unscheduled contacts with hospital regarding tibia fracture

    Measured: 24 months

  20. Resource use; Length of stay

    Hospital stay in days for index stay

    Measured: 24 months

  21. Resource use; Operation time

    Surgery time in minutes for index surgery

    Measured: 24 months

Timeline

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

  1. First posted3 Jan 2018
  2. Study start31 Oct 2010
  3. Primary completion16 Jun 2015
  4. Study completion21 Jun 2016

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
Prospective randomized two-group clinical trial with block randomization.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388879
Sponsor's protocol ID
REKC 2010/1706
Acronym
NAFTI
Status last verified
Dec 2017
First submitted
17 Dec 2017
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Depending on demand. No plan as of yet.

Questions about this trial

What is this clinical trial studying?

A study testing Taylor Spatial Frame and Intramedullary nail in people with Tibial Fractures, run by Oslo University Hospital at 1 site in Norway.

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 6 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 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

Physical Component summary of RAND SF 36 (Short Form 36) (time frame: 24 months). 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 NCT03388879.

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 3 Jan 2018.

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