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

Ankle Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02823275
• Other study ID #: 683-250210-Nicolaas
• Status: Terminated
• Phase: N/A
• First received: June 27, 2016
• Last updated: July 5, 2016
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: June 2016
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Fractures
• Fractures, Bone

Intervention

Other:
• Functional mobilisation
functional mobilisation
• Short term plaster cast fixation
2 weeks cast immobilisation

Locations

Country	Name	City	State
Netherlands	Rijnstate	Arnhem	Gelderland
Netherlands	Radboud University	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain	Visual Analog Pain Scale	6 weeks	No
Primary	Pain medication used	amount of pain medication used	6 weeks	No