Skip to content

Prospective randomized study: early weight bearing after conservative treatment of stable ankle fractures.

Prospective randomized study: early weight bearing after conservative treatment of stable ankle fractures. - PANCAKE-trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46747
Enrollment
284
Registered
2018-03-06
Start date
2018-04-05
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

broken ankle stable ankle fracture

Interventions

Intervention group The dorsal lower limb cast will be removed by the plaster technician. Patients will get a Walker by which they can start with permissive weight bearing. According to protocol, the

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age of 16 years and older. - Stable ankle fracture (non-dislocated Weber B or Lauge Hansen supination-eversion stage 2-4A fracture, isolated malleolus tertius fracture) - Conversative treatment with a belowknee plaster cast.

Exclusion criteria

Exclusion criteria: - Age below 16 years. - Weber A ankle fracture. - Unstable ankle fracture. - Fractures involving both lower extremities. - Operative treatment of the ankle fracture. - Posttraumatic period more than 10 days. - Amputation of upper leg, lower leg or foot.

Design outcomes

Primary

MeasureTime frame
Functional outcome scores of the ankle. This will be indicated with the Olerud/Molander Ankle Function Score (OMAS). This is a continuous variable (0-100 points).

Secondary

MeasureTime frame
Dislocation of the fracture within 6 weeks (after placement of the Walker or circular lower limb plaster cast). This is a dichotomous variable (yes/no). Other study parameters Range of motion (ROM) of the ankle and circumference of the calf (physical examination), return to work, mental health outcome scores (SF-36 questionnaire) and other complications, such as deep vein thrombosis or surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)