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

NCT02823275 | Terminated

• 1 other identifier: 683-250210-Nicolaas
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• pain

  Visual Analog Pain Scale

  6 weeks

• Pain medication used

  amount of pain medication used

  6 weeks

Study Arms (2)

Functional mobilisation

ACTIVE COMPARATOR

Other: Functional mobilisation

plaster cast fixation

EXPERIMENTAL

Other: Short term plaster cast fixation

Interventions

Functional mobilisation OTHER

functional mobilisation

Functional mobilisation

Short term plaster cast fixation OTHER

2 weeks cast immobilisation

plaster cast fixation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Radboud University Medical Center: collaborator

Study Sites (2)

Rijnstate

Arnhem, Gelderland, Netherlands

Location

Radboud University

Nijmegen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Ankle Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Ankle Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 6, 2016
• Study Start: January 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: July 6, 2016

Record last verified: 2016-06

Locations

NL (2)