Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures (NAFTI)
Primary Purpose
Tibial Fractures
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Taylor Spatial Frame
Intramedullary nail
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Fractures
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)
Sites / Locations
- Orthopedic Center, Ulleval University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Circular frame external fixator
Intramedullary nail
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Vitality Subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Physical functioning, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Bodily pain, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
General health perceptions, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Physical role functioning, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Emotional role functioning, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Social role functioning, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Mental health, subscore of RAND (SF) 36
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Physical Component summary of RAND (SF) 36
Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.
Pain around the knee
VAS scale 0-10
Pain around the fracture site
VAS scale 0-10
Pain around the ankle
VAS scale 0-10
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)
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)
Reoperations minor (composite)
Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)
Reoperations major (composite)
Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)
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.
Resource use; Away from work
Number of days away from work for employed patients
Resource use; Emergency contacts
Number of unscheduled contacts with hospital regarding tibia fracture
Resource use; Length of stay
Hospital stay in days for index stay
Resource use; Operation time
Surgery time in minutes for index surgery
Full Information
NCT ID
NCT03388879
First Posted
December 17, 2017
Last Updated
December 30, 2017
Sponsor
Oslo University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03388879
Brief Title
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Acronym
NAFTI
Official Title
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 31, 2010 (Actual)
Primary Completion Date
June 16, 2015 (Actual)
Study Completion Date
June 21, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized two-group clinical trial with block randomization.
Masking
Outcomes Assessor
Masking Description
The researcher doing the statistical analyses will be masked for treatment Group (i.e. Group 1 or 2) in a databse blinded for treatment grioups and without variables indirectly revealing treatmnet arm. These will be analyzed later.
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Circular frame external fixator
Arm Type
Experimental
Arm Description
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.
Arm Title
Intramedullary nail
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Taylor Spatial Frame
Other Intervention Name(s)
Circular frame
Intervention Description
Circular external fixator
Intervention Type
Device
Intervention Name(s)
Intramedullary nail
Intervention Description
Antegrade intramedullary nail
Primary Outcome Measure Information:
Title
Physical Component summary of RAND SF 36 (Short Form 36)
Description
Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Vitality Subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Physical functioning, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Bodily pain, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
General health perceptions, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Physical role functioning, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Emotional role functioning, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Social role functioning, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Mental health, subscore of RAND (SF) 36
Description
Generic Health Related Quality of Life. Range 0 (worst) to 100 (best).
Time Frame
6, 12, 24 months
Title
Physical Component summary of RAND (SF) 36
Description
Generic Health Related Quality of Life. Mean value 50, standard deviation 10. Higher score better.
Time Frame
6, 12 months
Title
Pain around the knee
Description
VAS scale 0-10
Time Frame
6, 12, 24 months
Title
Pain around the fracture site
Description
VAS scale 0-10
Time Frame
6, 12, 24 months
Title
Pain around the ankle
Description
VAS scale 0-10
Time Frame
6, 12, 24 months
Title
Complications major (composite)
Description
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
Title
Complications minor (composite)
Description
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
24 months
Title
Reoperations minor (composite)
Description
Minor reoperation (e.g. remove/exchange pins, remove/exchange screws)
Time Frame
6, 12, 24 months
Title
Reoperations major (composite)
Description
Major reoperation (e.g. fasciotomy, exchange nail, surgery for refracture, revision for infection, surgery for non-union)
Time Frame
6, 12, 24 months
Title
Time to union (composite)
Description
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
6, 12, 24 months
Title
Resource use; Away from work
Description
Number of days away from work for employed patients
Time Frame
24 months
Title
Resource use; Emergency contacts
Description
Number of unscheduled contacts with hospital regarding tibia fracture
Time Frame
24 months
Title
Resource use; Length of stay
Description
Hospital stay in days for index stay
Time Frame
24 months
Title
Resource use; Operation time
Description
Surgery time in minutes for index surgery
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan E Madsen, PhD
Organizational Affiliation
Professor, head of research group
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedic Center, Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0408
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Depending on demand. No plan as of yet.
Learn more about this trial
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
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