Comparison of close contact cast (CCC) technique to open surgical reduction and internal fixation (ORIF) in the treatment of unstable ankle fractures in patients over 60 years

Not Applicable

Completed

• Conditions: Displaced unstable fracture of the ankle; Injury, Occupational Diseases, Poisoning; Fracture of lower leg, including ankle

• Registration Number: ISRCTN04180738
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2014 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/24621174 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27727383 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27735787 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31340972 (added 26/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-08
• Study Completion: 2014-10-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

1. Men or women aged over 60 years
2. Isolated displaced unstable ankle fracture
3. Ambulatory prior to the injury - in any capacity
4. Capable of giving informed consent
5. Capable of adhering to post-operative instructions
6. Resident within the catchment area of a recruiting hospital - can attend for 6 month follow up

Exclusion Criteria

1. Established critical limb ischaemia
2. Insulin dependent diabetes
3. Active leg ulceration
4. Open fractures
5. Serious contaminant disease - metastatic disease or terminal illness
6. Clinically substantial degenerative or inflammatory arthritis
7. Unfit for anaesthetic
8. Unable to give informed consent - cognitive impairment demonstrated by Mini-Mental State Exam (MMSE) of under 16/30
9. Patient unwilling to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Patient reported functional outcome measure based on the Olerud and Molander Ankle Score. This scores 10 separate activities:<br> Pain, stiffness, swelling, jumping, supports, activities of daily living, running, stair climbing and squatting with a range of 0 to 100.<br><br> Some of the items may not be relevant or sensitive to change in the older patient, including running, squatting and jumping so it will be analysed at each individual item level. If there is evidence of a significant floor effect these items will be excluded from the final analysis and be summarised as a modified Olerud and Molander Score.<br><br> All primary outcomes will be assessed at baseline, 6 weeks and 6 months.<br>