Ankle Fractures, Deltoid Ligament; Sprain (Strain) (Ankle)
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREAdditional 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.
Sponsors
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
Nordlandssykehuset HF
Ostfold Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicentre Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
; fluent in oral and written Norwegian language * isolated Weber type B fractures and Weber B+ posterior malleolar Mason Molloy class I. * Initial medial clear space (MCS)\>=7mm or weightbearing x-ray evaluated as unstable or primary reposition after fracture dislocation. * Pre-injury walking ability without aids.
Exclusion criteria
* assumed not compliant (drug use, cognitive- and/or psychiatric disorders). * previous history of ipsilateral ankle fracture or ipsilateral major ankle-/foot surgery. * open fx Gustilo Anderson II or more, multi-trauma and pathologic fracture. * neuropathies and generalized joint disease such as Rheumatoid Arthritis or other more severe condition in same extremity * fixation of tibial fragment or syndesmotic screw or suture button planned prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in radiological stability parameters with or without ligament suture at group level | 1 and 2 years after injury, function 5 years after injury will also be collected | Differences in medial clear space (mm) on weightbearing x-rays or Gravity test at group level |
| Patient-reported functional outcome 1 year after injury | 1 and 2 years after injury, function 5 years after injury will also be collected | Function will be measured in Olerud-Molander Ankle Score (OMAS) (ankle specific) (0 (worst)-100 (best)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic ankle arthritis | 1,2 and 5 years | 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) |
| VAS Pain | 6 weeks, 3 months, 1, 2 and 5 years | scale limited by intervals of no pain (0) and worst imaginable pain (100) |
| Self-reported Foot and Ankle Score (SEFAS) | 3 months, 1, 2 and 5 years | Ankle specific PROM based on 12 items, scale 0(worst) - 48 (best possible) |
| Ankle Fracture Outcome of Rehabilitation Measure | 3 months, 1, 2 and 5 years | Ankle Specific PROM based on 15 main items where 0 is the worst index score and 100 the best |
| Patient-Reported Outcomes Measurement Information System (PROMIS) | 1, 2 and 5 years | 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 |
| General health state reported through a general (generic) Patient-reported outcome measure (PROM) | up to 5 years | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications | especially on first visits after surgery ie 6 and 12 weeks, and later visits up to 5 years after surgery. | Infection, suture anchor malplacement, delayed/non-union and reoperation rate will be recorded. |
Countries
Norway
Contacts
Primary ContactEsten Konstad Haanæs, MD
Backup ContactMarius Molund, MD, PhD
Outcome results
None listed