Does internal rotation of the femur on a plain AP radiograph lead to significantly more accurate preoperative digital planning of the femoral component in THA in comparison to external rotation?
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the proportion of agreement of femoral
components planned for each of the externally rotated radiographs, compared to
the *gold standard* (15-20o of internal rotation).
Secondary outcome
Difference between Patient Reported Outcome Measures (PROMs) before and 1 year
after surgery per radiographical view.
Background summary
Preoperative digital planning is fundamental in the planning of total hip
arthroplasty (THA) because it prepares the hip surgeon and his/her surgical
team in the prediction of the type and size of the uncemented hip prosthesis
most suitable for a particular patient. In addition, it facilitates
anticipation on certain challenges, possibly reducing intraoperative
complications and surgical time.
To execute the preoperative planning adequately it is essential to provide a
proper and well-oriented Anterior-Posterior (AP) radiograph. Femoral rotation
influences the appearance and dimensions of the proximal femoral canal but due
to pain or impaired mobility, some patients are not able to rotate their leg
internally as required according to the current protocols.
The purpose of this study is to determine if the standard radiograph in 15-20
degrees of internal femoral rotation provides the best accuracy of preoperative
planning of THA. If so, it proves the importance of adhering to the current
standard protocol despite practical difficulties. If not, the need to force
patients who are unable to place their legs in internal rotation, would be less
relevant and radiographs could be adjusted to the patients ability to rotate
their legs, without affecting the accuracy of digital planning.
Study objective
Does internal rotation of the femur on a plain AP radiograph lead to
significantly more accurate preoperative digital planning of the femoral
component in THA in comparison to external rotation?
Study design
Prospective single-center cohort study.
Study burden and risks
From each patient, we will obtain four different radiographs: one axial view
with the feet in neutral (0°) position, one with the feet in 15 degrees of
internal rotation (*gold standard*), and 15 and 30 degrees of external
rotation. The estimated effective dose for a single AP pelvic radiograph is 70
mrem (0,7mSv) which makes the additional radiation exposure 2,1mSv for subjects
enrolled in the study. There is no direct evidence for the additional amount of
radiation to have any effect on human health. Patients will not benefit
directly from participation in the study, as preoperative planning will be
performed as usual.
Questionnaires for measurement of PROMs before and one year after surgery is
done for every patient and therefore requires no extra effort from the patient.
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Listed location countries
Age
Inclusion criteria
• Patients undergoing elective THA;
• Patients are able to place their foot exactly in the required positions for
radiographs;
• Patients are over 18 years of age at the time of surgery;
• Patients who are capable, willing, and able to give informed consent for
their participation in the study.
Exclusion criteria
• Patients undergoing a revision of a total hip arthroplasty;
• Patients who are unable to place their leg in the required positions;
• Patients who have a prosthesis in the contralateral hip, causing distortion
on radiographs;
• Severe metabolic disorders that may impair bone formation or compromise the
affected extremity which makes digital planning highly unreliable according to
the operating surgeons* judgement;
• Patients who are unable to read and/or write in Dutch.
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 | NL68224.075.19 |