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 postoperative…
ID
Source
Brief title
Condition
- Fractures
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life (RAND 36)
Function (goniometer, dynamometer, KOFOED)
Pain (VAS/NRS, pain medication, KOFOED),
Secondary outcome
Swelling (volumetric, figure of eight)
Daily activities and work (lower limb task questionnaire, resumption of work)
Disabilities (pain disability index)
Complications
Epidemiology
Background summary
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. The outcome of operatively
corrected ankle fractures in patients 18 years and older show good long-term
functional outcome rates. Earlier studies compared functional treatment in a
brace with immobilization in plaster for 6 weeks. Both 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, when using a short term plaster immobilization.
Our hypothesis is that short term plaster cast immobilisation compared to
direct functional treatment will lead to significantly less wound related
complications, less pain en less use of pain medication early in follow-up and
can lead to higher quality of life. We expect no significant difference in
ankle function between both groups six or more months after the initial
operation.
Study 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
postoperative ankle function, quality of life, pain and the use of pain
medication, and resumption of work and daily activities.
Study design
A prospective randomized multi-centre trial concerning the orthopaedic and
surgical departments of the Radboud University Medical Centre in Nijmegen and
Alysis Zorggroep, Rijnstate Hospital in Arnhem, The Netherlands.
Study burden and risks
During the first two [ostoperative weeks, patients will note their pain scores
and use of pain medication daily. Follow-up will be after 2 weeks, 6 weeks, 3
months and 6 months. Patients fill in four questionnaires. Besides general
physical examnination, extra measurements of swelling, function and power will
be taken. Expected time invested by patients is estimated at 30-45 minutes per
follow-up. Measurement methods are not invasive and are therefore not
considered an extensive burden.
Both treatments were evaluated in other studies and were applied before,
minimal risks are associated with both postoperative treatments with are
comparable to standard treatment. These risks are woundinfections, pressure
sores caused vij plaster cast immobilisation, deep venous thrombosis, and
failues of the osteosynthesis material.
The time the patients invests in this study gives us scientific information as
well as it leads to more extensive examination of the patient.
Theodoor Craanenlaan 7
6525 GH Nijmegen
NL
Theodoor Craanenlaan 7
6525 GH Nijmegen
NL
Listed location countries
Age
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-exorotation and pronation-exorotation
Uncomplicated fractures
Postoperative stable for exercise
Operated at the University Medical Centre St Radboud, Nijmegen or Alysis Zorggroep, Rijnstate Hospital, Arnhem
Exclusion criteria
-Complicated (open) fractures
-Fractures with 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30599.091.10 |