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

NCT ID: NCT02823275

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-11-30

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

Conditions

Ankle Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Functional mobilisation

Group Type: ACTIVE_COMPARATOR

Functional mobilisation

Intervention Type: OTHER

functional mobilisation

plaster cast fixation

Group Type: EXPERIMENTAL

Short term plaster cast fixation

Intervention Type: OTHER

2 weeks cast immobilisation

Interventions

Functional mobilisation

functional mobilisation

Intervention Type: OTHER

Short term plaster cast fixation

2 weeks cast immobilisation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Rijnstate Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rijnstate

Arnhem, Gelderland, Netherlands

Radboud University

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

683-250210-Nicolaas

Identifier Type: -

Identifier Source: org_study_id