Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation.
1 other identifier
interventional
40
1 country
1
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 whether the findings correlate with results on gravity stress test and weightbearing radiographs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2020
CompletedFirst Submitted
Initial submission to the registry
November 17, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2024
CompletedDecember 17, 2020
December 1, 2020
4 years
November 17, 2020
December 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Registration of adverse events
104 weeks.
Registration of fracture union
12 weeks.
Registration of the incidence of concomitant cartilage injuries.
Baseline.
Study Arms (2)
Nonoperative treatment if deltoid ligament is intact
EXPERIMENTALAirCast Air-stirrup (DJO Global) functional orthosis for 6 weeks.
Operative treatment if deltoid ligament is ruptured
EXPERIMENTALOpen reduction, internal fixation of the fibular fracture using plate and screws.
Interventions
Patients where the ankle is evaluated as stable using arthroscopy will be treated with conservative treatment using a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
Patients where the ankle is evaluated as unstable using arthroscopy will be operated on. Standard operative treatment is open reduction and internal fixation (ORIF) of the fracture using plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.
All participants, regardless of group allocation, will receive education focusing on basic self- management. A physiotherapist will be responsible for the education. The intention will be to increase self-efficacy and encourage self-management. Participants will learn about crutch walking, cast or orthosis usage, loading principles, be advised to stay physically active within proper restrictions and how to rest and reduce pain and swelling of the ankle in the acute phase. Participants will also receive a standard information brochure about the condition, treatment and basic self-management.
Eligibility Criteria
You may qualify if:
- 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).
- years of age.
- With pre-injury walking ability without aids.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Østfold HT
Sarpsborg, Østfold fylke, 1719, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marius Molund, Md, PhD
Ostfold HT
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Consultant Foot and Ankle Surgery
Study Record Dates
First Submitted
November 17, 2020
First Posted
December 17, 2020
Study Start
September 15, 2020
Primary Completion
September 15, 2024
Study Completion
September 15, 2024
Last Updated
December 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share