Post Operative Quality of Life and Pain in Ankle Fractures: Cast Versus Functional Treatment

Post Operative Evaluation of Quality of Life and Pain in Ankle Fractures: Cast Immobilisation Versus Functional Treatment

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02823275

Enrollment

Registered

2016-07-06

Start date

2012-01-31

Completion date

2012-11-30

Last updated

2016-07-06

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

Conditions

Ankle Fractures

Brief summary

Rationale: Ankle fractures are common traumatic lesions. In order to restore the anatomical situation of the ankle joint to prevent posttraumatic arthritis, these fractures often need surgical treatment. Both cast immobilisation and functional treatment have proved to be reliable postoperative treatment regimes. Insight into the quality of life and the level of pain is necessary to determine if these treatments can be related to higher patient satisfaction and earlier resumption of daily activities and work. Objective: The aim of this study is to examine two postoperative treatments for surgically corrected ankle fractures. Postoperative, direct functional mobilisation is compared to short term plaster cast fixation. The focus of this study is on quality of life, pain and the use of pain medication, and resumption of work and daily activities. Main study parameters/endpoints: Quality of life, Function, pain, swelling, daily activities and work, disabilities (pain disability index), complications

Interventions

OTHERFunctional mobilisation

functional mobilisation

OTHERShort term plaster cast fixation

2 weeks cast immobilisation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age 18-65 at the time of surgery * Ankle fractures needing operative correction * Weber type B or C, Lauge Hansen type supination-adduction, supination-external rotation and pronation-external rotation * Closed fractures * Postoperative stable for exercise * Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem

Exclusion criteria

* Open fractures * Fractures with complete dislocation of the ankle joint * Body Mass Index \> 30 * Previous ankle fracture on the affected side * Concomitant traumatic injuries reducing the ability for postoperative mobilization * Pre-existent use of pain medication, medication affecting fracture- and wound healing * Postoperative unstable for exercise * Co-morbidity: pain syndromes, Fontaine IIB, III and IV, symptomatic venous insufficiency, auto-immune disorders, rheumatic arthritis

Design outcomes

Primary

Measure	Time frame	Description
pain	6 weeks	Visual Analog Pain Scale
Pain medication used	6 weeks	amount of pain medication used

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026