The objective of this project is to 1. increase accuracy and reproducibility of the most critical step in hip arthroplasty i.e. cup positioning;2. to alleviate one of the major complications of the straight lateral approach, i.e. abductor…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter of the study is the difference in recovery after a
total hip arthroplasty with the anterior approach and a straight lateral
approach. In the 3D CT reconstructions, the main study parameter is the
difference in positioning the cup of a total hip arthoplasty after an anterior
approach and a straight lateral approach.
Secondary outcome
not applicable
Background summary
The anterior approach to hip replacement surgery allows the surgeon to reach
the hip joint from the front of the hip as opposed to the lateral (side) or the
posterior (dorsal) approach. In this way, the hip can be replaced without
detachment of any muscle from the pelvis or femur. In the present study,
comparison is made between the anterior approach and the straight lateral
approach. The focus will lie on the cup positioning, the user friendliness and
the clinical results. In addition, we plan to develop a surgical strategy that
alleviates one of the major complications of the straight lateral; abductor
insufficiency.
Study objective
The objective of this project is to
1. increase accuracy and reproducibility of the most critical step in hip
arthroplasty i.e. cup positioning;
2. to alleviate one of the major complications of the straight lateral
approach, i.e. abductor insufficiency.
3. To assess the clinical results of the anterior approach compared to straight
lateral approach.
Study design
expertise-based randomized controlled intervention study
Intervention
One group receives a hip replacement through a straight lateral approach and
one group through an anterior approach.
Study burden and risks
The patients included in the clinical trials will follow the normal
rehabilitation protocol, with the exception that they will have to take some
MRI scans and have to fill in several questionnaires. This will be done before
or after a normal control appointment and will cost no more than 10 minutes
each time. The risks involved with the intervention are no different from the
normal risks involved. This study does not impose more, pre- and postoperative,
risk to the patient than is seen in clinical performed hip replacement surgery.
For the 3D CT reconstruction, patients will be measured before and after
intervention (quantification of cup inclination with fluoroscopy and
anteversion with goniometer). This will involve 2 extra visits to the hospital
and a mild exposure to radiation (1.7 mSV).
The study will not provide personal benefits or increased, pre- and
postoperative, risk to the participating patients but future patients might
benefit from the results of the study performed.
Ultimately this will result in more insight in the anterior approach of the
hip.
Sportlaan 600
Den Haag 2566 MJ
NL
Sportlaan 600
Den Haag 2566 MJ
NL
Listed location countries
Age
Inclusion criteria
- Willing and able to participate in the study protocol
- Age > 18 years
- Diagnosed with hip problems which results in a hip replacement surgery.
Exclusion criteria
- Mental disabilities
- Language barrier
- Previous surgery to the hip or additional injury as in fractures
- Diabetes mellitus
- Preference towards surgeon or surgical method
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL32278.098.10 |