K FixDT: Fixation of Distal Tibia fractures

Completed

• Conditions: Distal Tibia Fractures / Injuries & Accidents; Injury, Occupational Diseases, Poisoning; Fracture of shaft of tibia

• Registration Number: ISRCTN99771224
• Lead Sponsor: niversity of Warwick (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26384729 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/29136444 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/29785926

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-10
• Study Completion: 2017-02-28
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1. Aged 16 years or over, either sex
2. Any fracture which involves the distal tibial metaphysis - defined as a fracture extending within 2 Muller squares of the ankle joint
3. In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture

Exclusion Criteria

Current exclusion criteria as of 03/02/2014:
1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
2. The fracture is open
3. There is a contra-indication to anaesthesia
4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires

Previous exclusion criteria:
1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
2. The fracture is open with a Gustillo grade of more than 1
3. There is a contra-indication to anaesthesia
4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires

Study & Design

• Study Type: Interventional
• Study Design: Not specified