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| Name | Class |
|---|---|
| Sykehuset Innlandet HF | OTHER |
| Helse Nord-Trøndelag HF | OTHER |
| Helse-Bergen HF | OTHER |
| Norwegian Institute of Public Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional treatment | No Intervention | Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus only | |
| Additional deltoid ligament suture | Experimental | Unstable Weber B fractures receiving standard treatment, plate and screw fixation of the lateral malleolus and additional deep deltoid ligament suture |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional deep deltoid ligament suture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion criteria; fluent in oral and written Norwegian language
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esten Konstad Haanæs, MD | Contact | +4799789013 | estenkh@gmail.com | |
| Marius Molund, MD, PhD | Contact | +4790093988 | mariusmolund@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Frede Jon Frihagen, MD, PhD | Oestfold Hospital Trust | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oestfold Hospital Trust | Recruiting | Grålum | Postbox 300 | N-1714 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol general august 2024 | Aug 16, 2024 | Aug 3, 2025 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study protocol update january 2025 | Jan 23, 2025 | Aug 3, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| D013180 | Sprains and Strains |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| OTHER_GOV |
| Helse Stavanger HF | OTHER_GOV |
| Trondheim University Hospital | OTHER |
| Norwegian University of Science and Technology | OTHER |
| Alesund Hospital | OTHER |
| Nordlandssykehuset HF | OTHER |
Multicentre Randomized Controlled Trial
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| 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 |
| Ålesund Sjukhehus | Recruiting | Ålesund | Norway |
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| Haukeland University Hospital | Recruiting | Bergen | Norway |
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| Nordlandssykehuset Bodø | Recruiting | Bodø | Norway |
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| Sykehuset Innlandet Elverum | Recruiting | Elverum | Norway |
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| Sykehuset Innlandet Gjøvik | Recruiting | Gjøvik | Norway |
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| Sykehuset Levanger | Recruiting | Levanger | Norway |
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| Oslo University Hospital Ullevål/Aker | Recruiting | Oslo | Norway |
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| Stavanger University Hospital | Recruiting | Stavanger | Norway |
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