Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation. (NCT04674046) | Clinical Trial Compass
UnknownNot Applicable
Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation.
Norway40 participantsStarted 2020-09-15
Plain-language summary
Prospective cohort study to evaluate the use of a NanoScopic procedure to assess deltoid ligament injuries with outcomes measured at baseline, 6 weeks, 12 weeks, 1 year and 2 years. Further to examine whether the findings correlate with results on gravity stress test and weightbearing radiographs.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients:
* With isolated Weber type B fractures without radiological signs of medial clear space widening on initial plain radiographs (MCS \< 7mm).
* Demonstrating at least one positive stress radiograph (weightbearing or gravity) or a plain radiograph with a MCS measurement above the threshold (5 mm AND 1 mm or more increase compared to the contralateral ankle) (WP2).
* 18-80 years of age.
* With pre-injury walking ability without aids.
Exclusion Criteria:
Patients:
* With fracture of the medial malleolus, pre-hospital closed fracture reduction, open fracture, fracture resulting from high-energy trauma or multi-trauma and pathologic fracture.
* With poorly regulated Diabetes Mellitus type 1 and 2, neuropathies and generalized joint disease such as Rheumatoid Arthritis.
* That are assumed not compliant (drug use, cognitive- and/or psychiatric disorders).
* With previous history of ipsilateral ankle fracture.
* With previous history of ipsilateral major ankle-/foot surgery.
What they're measuring
1
Change in Manchester-Oxford Foot Questionnaire (MOXFQ)