RCT Comparing Non-operative vs Operative Treatment of Suprasyndesmotic Ankle Fractures.
Ankle Fractures
About this trial
This is an interventional treatment trial for Ankle Fractures focused on measuring ankle fractures, surgical treatment, conservative treatment, weight-bearing
Eligibility Criteria
Inclusion Criteria:
- patients who present with a closed, isolated fibular fracture classified as suprasyndesmotic (Weber C) with a medial clear space of less than 7 mm in mortise view on primary radiographs.
- presentation less than 14 days after the injury.
Exclusion Criteria:
- previous fractures or ligamentous injury to the injured ankle.
- pathological fracture.
- diabetic neuropathy or other neuropathies.
- drug abuse.
- inability to consent and/or comply.
- inability to understand Norwegian language.
- inability to walk unaided prior to the fracture.
- patients with a concomitant tibial fracture requiring surgical treatment are excluded, but patients with undisplaced concomitant tibial fractures can be included.
- patients from outside the catchment area of the recruiting hospitals. However, they can be included if they are willing to undergo follow-up visits at one of the recruiting hospitals.
Sites / Locations
- Sykehuset Innlandet HF
- Vestre Viken Hospital Trust
- Østfold Hospital Trust
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Surgical treatment
Non-surgical treatment
Patients randomised to operative treatment will have their surgery performed by an orthopaedic surgeon or by orthopaedic trainees under the supervision of a consultant, when fit for surgery. The surgical technique and choice of implants will be decided by the surgeon in order to closely resemble everyday clinical practice. The syndesmosis must be reduced (closed or open) and fixed. Postoperatively, the patients will be treated with an ankle orthosis for six weeks with weight-bearing as tolerated.
Patients randomised to non-operative treatment are treated with an ankle orthosis for six weeks with weight-bearing as tolerated. Other types of casts can be used if preferred by the treating orthopaedic surgeon, but the cast must allow full weight-bearing and must prevent equinus position.