Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alesund Hospital | OTHER |
| Sykehuset Innlandet HF | OTHER |
Not provided
Not provided
Not provided
Not provided
Stability dictates treatment choice for trans-syndesmotic fibula fractures. Optimal treatment for partially unstable fractures remains a topic of debate. The purpose of this study is to evaluate possible outcome non-inferior of functional orthosis treatment versus cast immobilization for these fractures.
Evidence suggests that Weber B ankle fractures should be treated nonoperatively if the ankle mortise is stable. Stability is maintained if the deltoid ligament is intact, also known as a Weber B/SER2 injury. Functional orthosis treatment is advised for these injuries. Recently, authors have demonstrated that the fractured ankle can be functionally stable even with a partial deltoid ligament injury. Our interpretation of a partial deltoid ligament injury is when weightbearing radiographs indicate stability (no increase in medial clear space), while concomitant gravity stress radiographs indicate instability (due to increase in medial clear space). It is suggested that this is referred to as a Weber B/SER4a injury. Although now considered for nonoperative treatment, partially unstable/SER4a injuries were traditionally treated operatively. Today, the superiority of one method of nonoperative treatment over another for partially unstable/SER4a injuries remains unclear. Some authors advocate cast immobilization while others have shown good outcomes after inconsistently using different orthoses and cast devices. The argument for cast immobilization appears to be a fear of posttraumatic osteoarthritis because of potential recurrent instability. As a result, cast immobilization of partially unstable/SER4a fractures is implemented in reference European guidelines, and thus must be considered the reference treatment. To our knowledge, no study has documented increased prevalence of osteoarthritis associated with functional treatment of partially unstable/SER4a fractures. The use of cast immobilization remains a precautionary principle, but the choice is not so clear cut because cast immobilization comes with an increased risk of joint stiffness and thromboembolic complications. Long-term radiographic and patient-reported outcome data evaluating possible non-inferiority of functional orthosis treatment compared to cast immobilization will assist in guiding future treatment strategies of these common fractures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional orthosis | Experimental | Use of a functional orthosis device (AirCast Air-Stirrup) for 6 weeks. Weightbearing as tolerated will be allowed in both groups immediately after application of the cast or orthosis. |
|
| Cast immobilization | Active Comparator | Use of a below-the-knee cast circular cast (3M scotch cast) for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional orthosis | Device | See arm descriptions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Between-groups difference in Manchester-Oxford Foot and Ankle Questionnaire score at 2 years | Scale 0-100, lower scores indicate less pain and symptoms. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Between-groups difference in Olerud Molander Ankle Score at 2 years | Scale 0-100, higher scores indicate less pain and symptoms. | 2 years |
| Numeric rating scale of of patient satisfaction with treatment protocol |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ålesund Hospital | Ålesund | Norway | ||||
| Sykehuset Innlandet, Gjøvik |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
Masking is not possible during the first 6 weeks of treatment due to the nature of the interventions. Investigators and outcome assessors will be masked for follow-up after 6 weeks.
| Cast immobilization |
| Device |
See arm descriptions |
|
A 0-10 rating scale for perceived satisfaction with orthosis or cast
| 6 weeks |
| Tibiotalar congruity comparing injured and uninjured ankle at 2 years | Measurement of ankle medial clear space from weightbearing and gravity stress ankle radiographs | 2 years |
| Registrations of complications/adverse events | Registration of possible loss of congruence, delayed union, non-union, thromboembolic events | 2 years |
| Change from 6 weeks ankle range of motion at 2 years | Measurement using a goniometer (ad modum Lindsjø) | 6 weeks, 2 years |
| Gjøvik |
| Norway |
| Østfold Hospital Trust | Sarpsborg | Østfold fylke | 1714 | Norway |