Clinical trial NCT03388879: Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Official title: Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Fractures
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2018-01-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized two-group clinical trial with block randomization.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Physical Component summary of RAND SF 36 (Short Form 36)
timeFrame: 24 months
Secondary outcomes:
measure: Vitality Subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Physical functioning, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Bodily pain, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: General health perceptions, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Physical role functioning, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Emotional role functioning, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Social role functioning, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Mental health, subscore of RAND (SF) 36
timeFrame: 6, 12, 24 months
measure: Physical Component summary of RAND (SF) 36
timeFrame: 6, 12 months
measure: Pain around the knee
timeFrame: 6, 12, 24 months
measure: Pain around the fracture site
timeFrame: 6, 12, 24 months
measure: Pain around the ankle
timeFrame: 6, 12, 24 months
measure: Complications major (composite)
timeFrame: 24 months
measure: Complications minor (composite)
timeFrame: 24 months
measure: Reoperations minor (composite)
timeFrame: 6, 12, 24 months
measure: Reoperations major (composite)
timeFrame: 6, 12, 24 months
measure: Time to union (composite)
timeFrame: 6, 12, 24 months
measure: Resource use; Away from work
timeFrame: 24 months
measure: Resource use; Emergency contacts
timeFrame: 24 months
measure: Resource use; Length of stay
timeFrame: 24 months
measure: Resource use; Operation time
timeFrame: 24 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Orthopedic Center, Ulleval University Hospital
Study officials:
affiliation: Professor, head of research group
name: Jan E Madsen, PhD
role: STUDY_CHAIR
References: