An interventional study of Additional deep deltoid ligament suture in Ankle Fractures and Deltoid Ligament; Sprain (Strain) (Ankle), sponsored by Ostfold Hospital Trust. Recruiting at 9 sites in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-13.
Sponsored by Ostfold Hospital Trust · Not applicable, Interventional, and Treatment
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.
During the last two decades less severe ankle fractures have been shown not to need operative treatment in general. The total number of ankle fracture surgeries has gone down. Therefore, surgically treated ankle fractures nowadays are on average more complex. The understanding of these injuries implies a recognition of the role of the deep deltoid ligament as a main stabilizer of the ankle joint. Deltoid ligament repair is documented to be a good option to regain ankle joint anatomy from smaller studies. This repair also compensates for syndesmotic injury to some extent. The effect of deep deltoid ligament repair in Weber B ankle fractures and its effect on long term function and arthritis is not yet known from clinical studies.
The investigators aim to show whether deltoid ligament suture gives a clinically significant superior result than solely osteosynthesis of the lateral malleolus in unstable ankle fractures. This will be performed as a multicentre randomized controlled study.
202 studies on the registry are indexed under Ankle Fractures; 44 are open to participants now.
This study's planned enrollment of 120 is above the median of 90 across 150 interventional studies indexed under Ankle Fractures.
Browse Ankle Fractures studies →Ostfold Hospital Trust is the lead sponsor of 50 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria; fluent in oral and written Norwegian language
Exclusion criteria
Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only
Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture
Procedure: Additional deep deltoid ligament suture
The deep deltoid ligament will be sutured through a curved incision lifting the tibialis posterior tendon out to be sutured back after tying the ligament to an anchor in the talus.
Patient-reported functional outcome 1 year after injury
Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best))
Time frame: 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
Time frame: 1 and 2 years after injury, function 5 years after injury will also be collected
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.
Time frame: 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)
Time frame: 1,2 and 5 years
VAS Pain
scale limited by intervals of no pain (0) and worst imaginable pain (100)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 3 months, 1, 2 and 5 years
Complications
Infection, suture anchor malplacement, delayed/non-union and reoperation rate will be recorded.
Time frame: especially on first visits after surgery ie 6 and 12 weeks, and later visits up to 5 years after surgery.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2024 (actual). Primary completion is estimated for Dec 2026, 27 months after the start.
Of 69 non-industry interventional studies with no phase under Ankle Fractures, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 61. This study's planned 27 months is below that.
Counting every sponsor, half of 72 studies reached it within 45 months; a quarter within 23 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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Ostfold Hospital Trust