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

Rijnstate Hospital

Status: Terminated

Conditions: Ankle Fractures

Treatments: Other: Short term plaster cast fixation; Other: Functional mobilisation

Study type: Interventional

Funder types: Other

Identifiers

NCT02823275

683-250210-Nicolaas

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Functional mobilisation

Active Comparator group

Treatment:

Other: Functional mobilisation

plaster cast fixation

Experimental group

Treatment:

Other: Short term plaster cast fixation