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TerminatedNCT02823275Updated Jul 6, 2016

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

An interventional study of Functional mobilisation and Short term plaster cast fixation in Ankle Fractures, sponsored by Rijnstate Hospital. Terminated at 2 sites in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-06.

Sponsored by Rijnstate Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Investigator changed jobs
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Ankle Fractures
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's enrollment of 13 is below the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
13 participants (actual)

Study arms

  • Active comparator
    Functional mobilisation

    Other: Functional mobilisation

  • Experimental
    plaster cast fixation

    Other: Short term plaster cast fixation

Interventions

  • OtherFunctional mobilisation

    functional mobilisation

  • OtherShort term plaster cast fixation

    2 weeks cast immobilisation

06

What researchers measure

Primary outcomes

  1. pain

    Visual Analog Pain Scale

    Time frame: 6 weeks

  2. Pain medication used

    amount of pain medication used

    Time frame: 6 weeks

07

Study locations

2 sites
  • Rijnstate
    Arnhem, Gelderland, Netherlands
  • Radboud University
    Nijmegen, Gelderland, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02823275
Lead sponsor
Rijnstate Hospital
Collaborators
Radboud University Medical Center
Responsible party
Sponsor
First posted
Jul 6, 2016
Start date
Jan 2012
Primary completion
Nov 2012
Completion
Nov 2012
Last update
Jul 6, 2016
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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