Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT06883435
Brief Summary:
The aim of this prospective randomized controlled trial is to compare the functional and radiographic outcomes of closed reduction and percutaneous cannulated screws fixation and ORIF in treatment of displaced isolated medial malleolar fractures.
Detailed Description:
Medial malleolar (MM) fractures occur in about 50% of all ankle fractures, and may occur as isolated MM fractures or as part of a bi- or tri-malleolar ankle fractures.
MM fractures may occur following road traffic accident, twisting injury to ankle, assault, and falling from height.
When MM fractures occurring as a part of a bi- or tri-malleolar ankle fractures, MM fractures are typically treated with surgical fixation. Isolated non-displaced MM fractures can be treated conservatively by below knee cast application. Displaced isolated MM fractures are usually treated surgically.
Many fixation techniques for MM fractures have been proposed including; unicortical partially threaded compression screws, bicortical fully threaded screws, buttress or neutralization plates, and tension band wiring. The choice of a particular fixation technique depends on the fracture geometry and the extent of comminution. Surgical procedures can be done by open reduction internal fixation (ORIF) or closed reduction percutaneous fixation.
In comparison to an ORIF, a percutaneous approach to MM fractures have potential advantages of decreased surgical morbidity, decreased postoperative pain, and decreased risk of wound complications. However, without direct fracture site visualization, it is possible that acceptable reduction could be hindered, leading to higher rates of nonunion and malunion. Some studies have shown that even in unstable medial malleolus fractures percutaneous screw fixation is excellent technique.
There is dilemma in the existing literature which treatment method is better for MM fractures management. Up to my knowledge, there is no comparative prospective study of ORIF versus percutaneous approach in surgical treatment of isolated medial malleolar fractures.
Study:
NCT06883435
Study Brief:
Protocol Section:
NCT06883435