The Benefit of Repairing the Deltoid Ligament in Unstable Ankle Fractures
NCT Number: NCT06568276
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ankle Fractures|Deltoid Ligament; Sprain (Strain) (Ankle)
Interventions: PROCEDURE: Additional deep deltoid ligament suture
Sponsor: Ostfold Hospital Trust
Collaborators: Sykehuset Innlandet HF|Helse Nord-Trøndelag HF|Helse-Bergen HF|Norwegian Institute of Public Health|Helse Stavanger HF|Trondheim University Hospital|Norwegian University of Science and Technology|Alesund Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2031-12-31
Locations: Oestfold Hospital Trust, Grålum, Postbox 300, N-1714, Norway

Summary:
Ankle fractures occur in 1 out of 800 persons a year and is a common injury. The deltoid ligament is necessary for the stability of the joint and guides choice of treatment. Cadaveric studies have shown that deltoid ligament repair gives more stability than the osteosynthesis of the lateral malleolus itself. The investigators want to show if suture of the deltoid ligament in unstable ankle fractures contribute to a better functional result and/or prevent long term osteoarthritis for our participants. Patients sustaining severe ankle fractures have shown a considerable loss of function that might affect their long term activities of daily living (ADL) function. Improving outcome for this group may preserve some patients' ability to work and reduce community expenses.

Primary Outcome Measures: Patient-reported functional outcome 1 year after injury, Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best)), 1 and 2 years after injury, function 5 years after injury will also be collected|Differences in radiological stability parameters with or without ligament suture at group level, Differences in medial clear space (mm) on weightbearing x-rays or Gravity test at group level, 1 and 2 years after injury, function 5 years after injury will also be collected
Secondary Outcome Measures: General health state reported through a general (generic) Patient-reported outcome measure (PROM), The generic Euroquol EQ-5D (EQ 5D-5L) reports general health based on 5 items where Index scores range from -0.59 to 1; 1 is the best possible health state. Negative values represent health states perceived as worse than dead, which is equal to 0., up to 5 years|Posttraumatic ankle arthritis, Arthritis seen on weightbearing x-rays will be reported according to Kellgren Lawrence Scale (KGLS) (0 no arthritis to 4 severe/end stage arthritis with bone to bone contact and bone wear and osteophytes), 1,2 and 5 years|VAS Pain, scale limited by intervals of no pain (0) and worst imaginable pain (100), 6 weeks, 3 months, 1, 2 and 5 years|Patient-Reported Outcomes Measurement Information System (PROMIS), We will use a version of the Mobility bank 2.1. The setup and calculation method is still not clear. We await further progress from the organization developing this PROM. We hope to get a computer adapted testing (CAT) version of this survey ready in a Norwegian version within the start of 1 year follow up in September 2025, 1, 2 and 5 years|Self-reported Foot and Ankle Score (SEFAS), Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible), 3 months, 1, 2 and 5 years|Ankle Fracture Outcome of Rehabilitation Measure, Ankle Specific PROM based on 15 main items where 0 is the worst index score and 100 the best, 3 months, 1, 2 and 5 years
Other Outcome Measures: Complications, Infection, suture anchor malplacement, delayed/non-union and reoperation rate will be recorded., especially on first visits after surgery ie 6 and 12 weeks, and later visits up to 5 years after surgery.