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Completed

NCT Number: NCT03388879

Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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)

Treatment and study plan

Taylor Spatial Frame

Device

Circular external fixator

Other names: Circular frame

Intramedullary Nail

Device

Antegrade intramedullary nail

Primary outcomes

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

    Time frame: 24 months

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

Secondary outcomes

  1. Vitality Subscore of RAND (SF) 36

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

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

    Time frame: 6, 12, 24 months

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

  9. Physical Component summary of RAND (SF) 36

    Time frame: 6, 12 months

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

  10. Pain around the knee

    Time frame: 6, 12, 24 months

    VAS scale 0-10

  11. Pain around the fracture site

    Time frame: 6, 12, 24 months

    VAS scale 0-10

  12. Pain around the ankle

    Time frame: 6, 12, 24 months

    VAS scale 0-10

  13. Complications major (composite)

    Time frame: 24 months

    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)

  14. Complications minor (composite)

    Time frame: 24 months

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

  15. Reoperations minor (composite)

    Time frame: 6, 12, 24 months

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

  16. Reoperations major (composite)

    Time frame: 6, 12, 24 months

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

  17. Time to union (composite)

    Time frame: 6, 12, 24 months

    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.

  18. Resource use; Away from work

    Time frame: 24 months

    Number of days away from work for employed patients

  19. Resource use; Emergency contacts

    Time frame: 24 months

    Number of unscheduled contacts with hospital regarding tibia fracture

  20. Resource use; Length of stay

    Time frame: 24 months

    Hospital stay in days for index stay

  21. Resource use; Operation time

    Time frame: 24 months

    Surgery time in minutes for index surgery

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Acronym: NAFTI

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Jan 3, 2018
Registry last updated
Jan 3, 2018

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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