Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01758796 |
| Other study ID # |
OYSrct-Ankle3.2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2013 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
September 2023 |
| Source |
University of Oulu |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Current gold standard treatment for unstable (those found unstable in external rotation (ER)
stress testing Weber B-type, Lauge-Hansen supination-external rotation type IV) ankle
fractures is open reduction and internal fixation (ORIF) with semitubular plates and screws.
However, there is some preliminary evidence to suggest that these type of fibula fractures
can be managed non-operatively with comparable functional outcome. The aim of this
randomized, non-inferiority trial is to assess whether non-operative treatment (cast
immobilisation) yields a non-inferior functional outcome compared to surgery with no excess
harms (primarily, fracture and wound healing problems and infection).
Description:
Seventy per cent of ankle fractures are unimalleolar injuries, the Weber B -type of fibula
fracture being by far the most common type. The ankle mortise can either be stable or
unstable in this type of fracture depending on the accompanying soft tissue injury. The
stability of the ankle mortise has fundamental clinical relevance, as it dictates the
subsequent treatment strategy. If left untreated, an unstable ankle mortise may lead to
fracture healing complications and increased risk of post-traumatic osteoarthritis and
subsequently poor functional outcome. Therefore, current clinical practice guidelines
recommend surgical treatment for these injuries. The gold standard surgical treatment for
unstable ankle fractures is open reduction and internal fixation (ORIF) using 1/3
semi-tubular plates and screws.
The most common complication following operative treatment of ankle fracture is wound
infection, the incidence ranging from 6.1 to10% in unselected patient materials.
To date, there is only one published randomized trial comparing operative and non-operative
treatment in patients with an unstable unimalleolar fibula fracture. In this 1-year
follow-up, the authors concluded that patients managed nonoperatively had equivalent
functional outcomes compared with operative treatment; however, the risk of fracture
displacement and problems with union was substantially higher in patients managed
nonoperatively. In turn, 10/41 (24%) patients treated operatively were re-operated; five
patients had a post-operative infection and five patients required hardware removal.
This prospective randomized non-inferiority trial is designed to compare surgical and
non-operative treatment of ER-stress positive unimalleolar ankle fractures. The primary,
non-inferiority, intention-to-treat outcome is the Olerud-Molander Ankle Score at 104 weeks
or 24 months (OMAS; range, 0-100; higher scores indicating better outcome and fewer
symptoms). The predefined non-inferiority margin for the primary outcome at the primary
assessment time point is 8 points. Secondary outcomes are ankle function, pain, quality of
life, ankle range of motion, and radiographic outcome. Follow-up assessments are performed at
2, 6, 12, and 104 weeks (primary time point). Treatment related complications and harms;
symptomatic non-unions, loss of congruity of the ankle joint, and wound infections are also
recorded.
The ER-stress test is performed by a consultant trauma orthopedic surgeon or a trauma
resident who has completed trauma rotation. Medial clear space opening of 5 mm or more will
be considered a positive ER stress test. Patients are randomized to non-operative or surgical
treatment using a sealed envelope method. Surgical treatment is carried out using a standard
open reduction and internal fixation with 1/3 semitubular plate and screws. Post-operatively,
surgically treated ankles are placed in a below-the-knee cast for six weeks. They are advised
to carry out partial weight-bearing (15 to 20 kilograms) for the first four weeks and then
weight-bear as tolerated for the remaining two weeks. The non-operative treatment protocol is
similar to that of the surgically treated patients: six-week below-the-knee cast with partial
weight-bearing for the first four weeks and then weight-bearing as tolerated for the
remaining two weeks.
