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New treatment option for Ankle Fracture, Bimalleolar
Official title Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures
ClinicalTrials.gov ID: NCT05765929
What this study is testing
- What it's testing
- The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by...
- With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici...
- With fractures in the distal 1/3 of fibula (not-Maisonneuve)
- Enabling stability evaluation within 14 days after injury
- 18-75 years of age
You likely can't join if
- \- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs
- With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and...
- With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
- With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the...
- With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
- With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
See the full eligibility criteria
- -With bi- and trimalleolar ankle fractures with less than 7 mm medial clear space on non-weightbearing radiographs that are deemed stable by weightbearing radiographs.
- With type B medial malleolus fractures between the tip and the plafond and type C medial malleolus fractures at the level of the plafond (Herscovici classification). (6)
- With fractures in the distal 1/3 of fibula (not-Maisonneuve)
- Enabling stability evaluation within 14 days after injury
- 18-75 years of age
- with pre-injury walking ability without aids
- \- With primary unstable ankle fractures, \> 7mm medial clear space on primary radiographs
- With fracture reduction prior to initial radiographic evaluation, open fracture, fractures resulting from high-energy trauma or multi trauma and pathological fracture
- With type A medial malleolus avulsion fractures \< 5mm (at the tip of the malleolus), that are not suitable for surgical intervention.
- With Herscovici type D fractures, involving Lauge-Hansen SA2 fractures (supracollicular fracture - vertical, oblique or transverse direction of the plafond)
- With displaced posterior malleolus fractures that needs fixation in the judgement of the attending surgeon
- With neuropathies and symptomatic joint diseases such as Rheumatoid Arthritis
- That are assumed not compliant (such as drug abuse, cognitive- and/or psychiatric disorders)
- With previous history ipsilateral ankle fracture
- With previous history ipsilateral major ankle-/foot surgery
- Who live outside the hospital catchment areas not available to follow up
- With insufficient Norwegian or English language skills
- Non-compliant
The study team makes the final eligibility decision.
Where it's taking place
- Sarpsborg, Østfold fylke, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarpsborg, Østfold fylke, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.