Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03107767
• Date of registration: 05/04/2017
• Prospective Registration: No
• Primary sponsor: Hvidovre University Hospital
• Public title: Study of Re-operation Rate After Introduction of Evidence Based Algorithm for the Treatment of Ankle Fractures PRO-Malleol
• Scientific title: The PRO-malleol Study
• Date of first enrolment: June 1, 2016
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03107767
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Peter T Tengberg, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients treated for ankle fractures at our institution during the study period
are asked to participate in the study.

Exclusion Criteria:

- Not speaking danish Not followed up at our institution Not mentally capable of filling
out questionnaire



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Posterior Malleolus Fractures

Syndesmotic Injuries

Ankle Fractures

Surgery

Intervention(s)

Procedure: PRO-malleol algorithm

Primary Outcome(s)

Change in re-operation rate [Time Frame: one year]

Rate of surgery for isolated lateral ankle fractures [Time Frame: one year]

Secondary Outcome(s)

Rate of complications not requiring surgery [Time Frame: One year]

SF 36 [Time Frame: day 0 and 12 months]

Forgotten Joint Score [Time Frame: Before fracture, 6 weeks, 12 weeks and 1 year]

Ollerud Molander Ankle Score [Time Frame: Before fracture, 6 weeks, 12 weeks and 1 year]

Secondary ID(s)

PRO-Malleol study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors