Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

Tibial Fractures Clinical Trial

— NAFTI  

Official title:

Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388879
• Other study ID #: REKC 2010/1706
• Status: Completed
• Phase: N/A
• First received: December 17, 2017
• Last updated: December 30, 2017
• Start date: October 31, 2010
• Est. completion date: June 21, 2016

Study information

• Verified date: December 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 21, 2016
• Est. primary completion date: June 16, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

Device:
• Taylor Spatial Frame
Circular external fixator
• Intramedullary nail
Antegrade intramedullary nail

Locations

Country	Name	City	State
Norway	Orthopedic Center, Ulleval University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Secondary	Vitality Subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Physical functioning, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Bodily pain, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	General health perceptions, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Physical role functioning, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Emotional role functioning, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Social role functioning, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Mental health, subscore of RAND (SF) 36	Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).	6, 12, 24 months
Secondary	Physical Component summary of RAND (SF) 36	Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.	6, 12 months
Secondary	Pain around the knee	VAS scale 0-10	6, 12, 24 months
Secondary	Pain around the fracture site	VAS scale 0-10	6, 12, 24 months
Secondary	Pain around the ankle	VAS scale 0-10	6, 12, 24 months
Secondary	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)	24 months
Secondary	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)	24 months
Secondary	Reoperations minor (composite)	Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)	6, 12, 24 months
Secondary	Reoperations major (composite)	Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)	6, 12, 24 months
Secondary	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.	6, 12, 24 months
Secondary	Resource use; Away from work	Number of days away from work for employed patients	24 months
Secondary	Resource use; Emergency contacts	Number of unscheduled contacts with hospital regarding tibia fracture	24 months
Secondary	Resource use; Length of stay	Hospital stay in days for index stay	24 months
Secondary	Resource use; Operation time	Surgery time in minutes for index surgery	24 months