Status:
COMPLETED
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Sahlgrenska University Hospital
Conditions:
Tibial Fractures
Eligibility:
All Genders
18-70 years
Phase:
NA
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 b...
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 fractu...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03388879
Start Date
October 31 2010
End Date
June 21 2016
Last Update
January 3 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Orthopedic Center, Ulleval University Hospital
Oslo, Norway, 0408