Ankle Fractures Clinical Trial
Official title:
Deep Deltoid Ligament Integrity in Ankles With Isolated Weber Type B Fractures - Mini-invasive Arthroscopic Evaluation Using the Arthrex NanoScope.
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | September 15, 2024 |
Est. primary completion date | September 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Østfold HT | Sarpsborg | Østfold |
Lead Sponsor | Collaborator |
---|---|
Ostfold Hospital Trust |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Manchester-Oxford Foot Questionnaire (MOXFQ) | The MOXFQ (Dawson et al., 2006) was developed to measure perceived foot- specific functioning and health-related quality of life. The MOXFQ is supported as the current most valid, reliable and responsive ankle-specific instrument (Jia, Huang, & Gagnier, 2017) and has been validated for use in ankle pathology (Dawson et al., 2011). It is available in Norwegian, but it has not been validated in its translated form. The score comprises a total of 16 items. They are distributed within 3 dimensions; foot pain (5 items), walking/standing (7 items) and social interaction (4 items) where all items are scored on a 5-point Likert scale, scored 0 (best) to 4 (worst). The MOXFQ index (Morley et al., 2013) will be used, where scores are converted to a metric (0-100) scale. Lower scores indicate less pain and higher levels of ankle/foot functioning (Morley et al., 2013). | 6 weeks, 12 weeks, 52 weeks, 104 weeks | |
Secondary | Registration of adverse events | Adverse events including malalignment, deep vein trobosis, nerve injury, wound infection, delayed wound healing and crossover to surgery (including reason for crossover). | 104 weeks. | |
Secondary | Registration of fracture union | Fracture union will be registered as union/nonunion and defined as concurrent radiographic evidence of fracture union and pain-free palpation over the fracture location. | 12 weeks. | |
Secondary | Registration of the incidence of concomitant cartilage injuries. | Evaluated peroperatively by minimally invasive arthroscopy. | Baseline. |
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