Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568276
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-22
Brief Title:
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures Patient-reported Functional Outcome and Radiological Stability Measurements
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ankle fractures occur in 1 out of 800 persons a year and is a common injury The deltoid ligament is necessary for the stability of the joint and guides choice of treatment Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result andor prevent long term osteoarthritis for our participants Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living ADL function Improving outcome for this group may preserve some patients ability to work and reduce community expenses
Detailed Description:
During the last two decades less severe ankle fractures have been shown not to need operative treatment in general The total number of ankle fracture surgeries has gone down Therefore surgically treated ankle fractures nowadays are on average more complex The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies This repair also compensates for syndesmotic injury to some extent The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies
The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures This will be performed as a multicentre randomized controlled study
The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures This will be performed as a multicentre randomized controlled study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None