Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures (NAFTI)

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.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Device: Taylor Spatial Frame; Device: Intramedullary nail

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0408
    • Orthopedic Center, Ulleval University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Circular external fixator; Other Names: Circular 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; Antegrade intramedullary nail

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Study Chair: Jan E Madsen, PhD, Professor, head of research group

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2010
• Primary Completion (Actual): June 16, 2015
• Study Completion (Actual): June 21, 2016

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 30, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: REKC 2010/1706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Depending on demand. No plan as of yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No