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CompletedNCT03388879NAFTIUpdated Jan 3, 2018

Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

An interventional study of Taylor Spatial Frame and Intramedullary nail in Tibial Fractures, sponsored by Oslo University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by Oslo University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 1 month after the study started (first participant enrolled Oct 2010, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Tibial Fractures

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03

In context

Tibial Fractures

162 studies on the registry are indexed under Tibial Fractures; 41 are open to participants now.

This study's enrollment of 65 is close to the median of 63 across 108 interventional studies indexed under Tibial Fractures.

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Lead sponsor

Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    Circular frame external fixator

    A 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.

    Device: Taylor Spatial Frame

  • Active comparator
    Intramedullary nail

    Nailing 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)

    Device: Intramedullary nail

Interventions

  • DeviceTaylor Spatial Frame

    Circular external fixator

    Also known as: Circular frame

  • DeviceIntramedullary nail

    Antegrade intramedullary nail

06

What researchers measure

Primary outcomes

  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.

    Time frame: 24 months

Secondary outcomes

  1. Vitality Subscore of RAND (SF) 36

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 6, 12, 24 months

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

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

    Time frame: 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.

    Time frame: 6, 12 months

  10. Pain around the knee

    VAS scale 0-10

    Time frame: 6, 12, 24 months

  11. Pain around the fracture site

    VAS scale 0-10

    Time frame: 6, 12, 24 months

  12. Pain around the ankle

    VAS scale 0-10

    Time frame: 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)

    Time frame: 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)

    Time frame: 24 months

  15. Reoperations minor (composite)

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

    Time frame: 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)

    Time frame: 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.

    Time frame: 6, 12, 24 months

  18. Resource use; Away from work

    Number of days away from work for employed patients

    Time frame: 24 months

  19. Resource use; Emergency contacts

    Number of unscheduled contacts with hospital regarding tibia fracture

    Time frame: 24 months

  20. Resource use; Length of stay

    Hospital stay in days for index stay

    Time frame: 24 months

  21. Resource use; Operation time

    Surgery time in minutes for index surgery

    Time frame: 24 months

07

Study locations

1 site
  • Orthopedic Center, Ulleval University Hospital
    Oslo, 0408, Norway
08

References and documents

Individual participant data

Plan to share: Undecided — Depending on demand. No plan as of yet.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2010 to primary completion in Jun 2015, 55 months.

Of 46 interventional studies with no phase under Tibial Fractures, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's 55 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2017
First posted
Jan 3, 2018
StartActual
Oct 31, 2010
Primary completionActual
Jun 16, 2015
CompletionActual
Jun 21, 2016
Last update
Jan 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03388879
Lead sponsor
Oslo University Hospital
Collaborators
Sahlgrenska University Hospital
Responsible party
Frede Frihagen (Consultant, Oslo University Hospital) — Principal investigator
First posted
Jan 3, 2018
Start date
Oct 31, 2010
Primary completion
Jun 16, 2015
Completion
Jun 21, 2016
Last update
Jan 3, 2018

Study contacts

Jan E Madsen, PhD
study chair · Professor, head of research group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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