The WOW! Study, Weight-bearing or Non-Weight bearing. A prospective randomised multicenter comparison of three different care regimens after operatively fixed ankle fractures.

The WOW! Study, Weight-bearing or Non-Weight bearing. A prospective randomised multicenter comparison of three different care regimens after operatively fixed ankle fractures. - The WOW! Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43927

Enrollment

225

Registered

2012-11-19

Start date

2013-02-20

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

operated ankle fractures operatively fixed ankle fractures

Interventions

* A) Unprotected non-weight-bearing group: A compression bandage is placed directly after surgery. The bandage can be removed 24 hours postoperatively and patients will be allowed to move the ankle

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients from 18-65 years fractures classified as Lauge Hansen supination-eversion type 2,3 or 4 articular discongruity of > 2 mm on radiograph (international indication for surgery)

Exclusion criteria

Exclusion criteria: Pre-existent impaired mobility Pre-existent cognitive disability Expected insufficiently stable fracture fixation with standard surgical technique Use of syndesmosis screw Tertius fragment which requires operative fixation Body Mass Index > 30 Diabetes mellitus Polytrauma patients (ISS>16 or >2 AIS regions involved) Gustilo 2 and 3 open fractures Inability to comply with non-weight bearing mobilisation (i.e. due to other injuries / co-morbidity) Inability to comply with follow-up (for example due to an inability to read or complete forms)

Design outcomes

Primary

Measure	Time frame
Olerud-Molander ankle score, 12 weeks after surgery	—

Secondary

Measure	Time frame
- Olerud-Molander ankle score (6 weeks and 1 year after surgery) - Number of wound related problems - Number of hardware failures - Range of motion of the ankle (6 and 12 weeks and 1 year after surgery) - Weight bearing, calf wasting and muscle strength (6 and 12 weeks) - Radiologic consolidation (6 and 12 weeks and 1 year after surgery) - Patient satisfaction: VAS and SF-36 (6 and 12 weeks and 6 and 12 months) - Period of resumption to work - Period of resumption of sports - Analysis of weight distribution of the operatively fixed ankle	—

Measure

Time frame

- Olerud-Molander ankle score (6 weeks and 1 year after surgery) - Number of wound related problems - Number of hardware failures - Range of motion of the ankle (6 and 12 weeks and 1 year after surgery) - Weight bearing, calf wasting and muscle strength (6 and 12 weeks) - Radiologic consolidation (6 and 12 weeks and 1 year after surgery) - Patient satisfaction: VAS and SF-36 (6 and 12 weeks and 6 and 12 months) - Period of resumption to work - Period of resumption of sports - Analysis of weight distribution of the operatively fixed ankle

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)