Clinical Trial: Early Weightbearing and Mobilization Versus Non-Weightbearing and Mobilization in Unstable Ankle Fractures

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Early Weightbearing and Mobilization Versus Non-Weightbearing and Immobilization After ORIF of Unstable Ankle Fractures: a Randomized Controlled Trial

Brief Summary: The primary objective of the investigators randomized controlled trial is to determine if early protected weightbearing and ankle range of motion after surgical treatment (open reduction internal fixation - ORIF) for ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

Detailed Summary:

This is a randomized controlled trial comparing early weightbearing and mobilization VS immobilization and non-weightbearing after initial treatment of unstable ankle fractures.

The primary objective of our randomized control trial is to determine if early protected weightbearing and ankle range of motion post open reduction internal fixation (ORIF) for unstable ankle fractures improves the rate of return to work and functional outcome compared to postoperative ankle immobilization in a non-weightbearing cast.

Our secondary objective is to determine the rate of adverse events (wound healing, infection, hardware failure) with early weightbearing and ROM comparable to rates with traditional post-op ankle immobilization.


Sponsor: University of Toronto

Current Primary Outcome: Return to work [ Time Frame: 3 months ]

Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work compared to traditional post-op ankle immobilization in a non-weightbearing cast?


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Functional outcome and event rate [ Time Frame: 2 weeks ]
    Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
  • Functional outcome and event rate [ Time Frame: 6 weeks ]
    Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
  • Return to work and functional outcome [ Time Frame: 9 weeks ]
    Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
  • Return to work and functional outcome [ Time Frame: 6 months ]
    Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?
  • Return to work and functional outcome [ Time Frame: 12 months ]
    Does early weightbearing and ankle range of motion post open reduction internal fixation for unstable ankle fractures improve the rate of return to work, functional outcome and rate of adverse events compared to traditional post-op ankle immobilization in a non-weightbearing cast?


Original Secondary Outcome: Same as current

Information By: University of Toronto

Dates:
Date Received: September 1, 2010
Date Started: September 2010
Date Completion: June 2012
Last Updated: June 9, 2011
Last Verified: September 2010