The aim of this study is to investigate the safety of immediate full weight bearing after acetabular fractures.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
Fracture dislocation measured in mm by Low Dose CT-scan.
Secondary outcome
Secondary endpoint:
Functional status 12 weeks post surgery, measured by the Merle d*aubigné
score
General heath 12 weeks post surgery, measured by the SF-36
Background summary
Treatment of displaced acetabular fractures involves a period of non weight
bearing for 8 to 12 weeks. This regime of non weight bearing has multiple
disadvantages: the energy needed for mobilizing non weight bearing is 4 times
higher than mobilize weight bearing, development of muscle atrophy after
immobilization and longer time till full recovery. In all 313 patients treated
in our medical center for acetabular fracture, no dislocation of fracture
alignment was seen after full weight bearing. These data shows that, in
potential, acetabular fractures are treated to conservative with regard to
early mobilization. Early mobilization after acetabular fractures would
probably lead to multiple advantages.
There are no studies published about the advantages of accelerated weight
bearing after acetabular fractures. Studies about accelerated weight bearing
after hip surgery showed: less morbidity, less mortality, better independent
ambulation, less medical cost, better quality of life and a decreased length of
stay compared to normal time to full weight bearing. Immediate full weight
bearing after acetabular fractures has potentially the same advantages as after
hip surgery en thereby the potential to improve the quality of medical care.
Study objective
The aim of this study is to investigate the safety of immediate full weight
bearing after acetabular fractures.
Study design
Patients will be included on the surgical ward. Patients will receive an
information letter preoperatively. After a minimal period of 24 hours patients
will be visited again ( in case of the operatively treated patient, after the
surgery when the patients is fully conscious. They will be asked if they have
any question regarding the study. Whenever the patient feels well informed
about the study and willing to participate, he will be asked to sign the
informed consent.
The surgeon who performed surgery will determine if the patient will be
enrolled in this study. We know that the decisions is based on a expert opinion
instead of objective terms. But factors that influence safety of early
weight-bearing are wide spread. For example type of fracture, fracture
displacement and bone quality. We will record all drop-outs with the reasons
explained by the surgeon.
Post surgery the patient will undergo low dose Pelvic CT control. When the
surgical drain is removed patient are allowed to fully load their operated leg.
Standard procedure is to remove the drain 2-3 days post surgery.
Patient will come to our outpatient clinic 1,2, 6 and 12 weeks post surgery. A
Low Dose CT will be performed for detecting fracture displacement.
Functional score (Merle d*aubigné score) and general health score (SF-36) will
be taken after surgery and at the outpatient clinic
Study burden and risks
Patients will be exposed to 5 extra Low Dose CT with a total radiation maximum
of 4,5 msV which is the same radiation dose as in normal follow up. Besides
radiation patients will be exposed to the risk of fracture displacement after
early full weight bearing.
The benefit of this study is that it will be the first study to test early full
weight bearing after acetabular fracture. And thereby provide the evidence for
other acetabular studies. Early weight-bearing is associated with: less
morbidity, less mortality, better independent ambulation, less medical cost,
better quality of life and a decreased length of stay compared to normal time
to full weight bearing. Participations of this study will have all of these
benefits.
Wolfskuilseweg 18F
Nijmegen 6542JK
NL
Wolfskuilseweg 18F
Nijmegen 6542JK
NL
Listed location countries
Age
Inclusion criteria
- Aged between 18 and 65 years
- Operatively treated acetabular fracture
- Mentally competent
- Capable to speak, read and understand Dutch
- Given oral and written informed consent
- surgical treatment of displaced acetabular fracture
Exclusion criteria
- Females who are pregnant, or suspected to be pregnant
- BMI > 35
- A history of an acetabular or pelvic fracture in the past
- Patients with pelvic fractures besides there acetabular fracture
- Fractures in the legs or spine or other injuries that may hinder normal
rehabilitation
- Known osteoporoses, defined by a DEXA scan
- Suspected osteoporoses on X-ray
- Intra operatively observed poor bone quality and/or insufficient bone stock
for firm osteosynthese observed by the surgeon
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 | NL56814.091.16 |