Status:
UNKNOWN
Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation.
Lead Sponsor:
Ostfold Hospital Trust
Conditions:
Ankle Fracture - Lateral Malleolus
Deltoid Ligament; Sprain (Strain) (Ankle)
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Detailed Description
Purpose and research question The main purpose is to evaluate integrity in the deep deltoid ligament in ankles with isolated Weber type B fractures using a minimally invasive Nanoscopic technique. Fur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04674046
Start Date
September 15 2020
End Date
September 15 2024
Last Update
December 17 2020
Active Locations (1)
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1
Østfold HT
Sarpsborg, Østfold fylke, Norway, 1719