Orthopedic Center, Ulleval University Hospital
Oslo, 0408, Norway
NCT Number: NCT03388879
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Oslo, 0408, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Circular external fixator
Other names: Circular frame
Antegrade intramedullary nail
Time frame: 24 months
Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12, 24 months
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time frame: 6, 12 months
Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.
Time frame: 6, 12, 24 months
VAS scale 0-10
Time frame: 6, 12, 24 months
VAS scale 0-10
Time frame: 6, 12, 24 months
VAS scale 0-10
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)
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)
Time frame: 6, 12, 24 months
Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)
Time frame: 6, 12, 24 months
Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)
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.
Time frame: 24 months
Number of days away from work for employed patients
Time frame: 24 months
Number of unscheduled contacts with hospital regarding tibia fracture
Time frame: 24 months
Hospital stay in days for index stay
Time frame: 24 months
Surgery time in minutes for index surgery
Oslo University Hospital
Other
Acronym: NAFTI
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