The primary aim of this study is to assess the long-term musculoskeletal function (Short Musculoskeletal Functional Assessment, SMFA) in patients who sustained an open pelvic ring fracture when they were aged
ID
Source
Brief title
Condition
- Bone and joint injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Musculoskeletal function (SMFA).
Secondary outcome
- The presence of growth disorders
- Urogenital function (VSSDES)
- Sexual dysfunction (IIEF-5 in males and FSFI in females)
- Motor function of the lower extremities (MRC scale)
- Sensory function of the lower extremities (soft touch and pin prick test for
gnostic and vial sensitivity, respectively).
Background summary
Pelvic ring fractures are relatively uncommon in the pediatric population
(0.3-7.5% of all pediatric fractures). Open pediatric pelvic ring fractures are
even more rare. Little or no data are available about the musculoskeletal
function, growth deformities, and neurological and urogenital function after
(non)operative treatment of open pelvic ring fractures. No specific case series
have been described in literature.
Study objective
The primary aim of this study is to assess the long-term musculoskeletal
function (Short Musculoskeletal Functional Assessment, SMFA) in patients who
sustained an open pelvic ring fracture when they were aged <18 years. The
secondary aims are to assess in these patients: 1) growth disorders (pelvic
X-ray); 2) urogenital function (Vancouver Symptom Score for Dysfunctional
Elimination Syndrome, VSSDES); 3) sexual dysfunction (International Index of
Erectile Function, IIEF-5, for males and Female Sexual Function Index, FSFI,
for females; 4) motor function of the lower extremities (Medical Research
Council, MRC, scale); and 5) sensory function of the lower extremities (soft
touch and pin prick test for gnostic and vial sensitivity, respectively).
Study design
Multicenter, retrospective case series with follow-up measurement.
Study burden and risks
Participants should not expect any personal benefits from their participation
in this study, but their participation may help future patients. There are only
negligible risks associated with this study. Patients will be invited for a
single follow-up visit at the outpatient department. During the visit, single
X-ray of the pelvis will be made, and the sensomotoric function of a leg will
be assessed. In addition, patient will be asked to complete three short
questionnaires on musculoskeletal function, urinary incontinence, and (if 18+
years) sexual dysfunction, which will take approximately 30 minutes. Besides
this, already existing data will be collected from the patients* medical files
and the Trauma Registry. The study is deemed to be group-related, as it cannot
be conducted without the participation of subjects belonging to the group in
question.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
1) Age at trauma below 18 years
2) Open pelvic ring fracture (since January 1, 2001).
3) Written informed consent by patient or parents in case patient has age below
16 years at follow-up
Exclusion criteria
1) Less than 30 days of follow-up post-trauma
2) Unknown contact details for patient *
3) Insufficient understanding of Dutch language to understand the
questionnaires or other study information, in the judgement of the research
team *
* Also applies to parents if the patient is <16 years at follow-up.
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 | NL78064.078.21 |