The purpose of our pilot study is to assess the status of the external rotator muscles and tendons of the hip after the DAA, with prospective Magnetic Resonance Imaging (MRI)
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 is assessing abnormalities of the external hip
rotators on MRI by describing dehiscence of one or more tendons and grading
muscle fatty atrophy.
Secondary outcome
To assess if the intraoperative estimated external rotator tendon release
corresponds to postoperative abnormalities of the external rotators on MRI
To assess if there is a relation between external rotator abnormalities on MRI
and postoperative hip function (including external rotation force) and pain
symptoms (measured using questionnaires).
Background summary
The Direct Anterior Approach (DAA) is the standard approach for total hip
replacement in our the Haga Hospital. This approach has rapidly gained
popularity over the last decade because it is the approach that causes least
muscle or tendon damage in comparison to other approaches to the hip.
Nevertheless, for correct placement of the femur stem of the total hip
prosthesis, soft tissue release at the proximal femur is needed. Ideally only
the hip joint capsule is partially released from the greater trochanter, and
this regrows in the first 6 weeks after the operation. But due to the close
proximity of the capsule and the insertion of the five external hip rotator
tendons at the greater trochanter, some of these tendons may also be detached.
When released, these tendons are not repaired at the end of the procedure. It
is unknown whether these tendons reattach to their insertion site, whether and
to which extent muscle atrophy results, nor whether such atrophy, if present,
has functional consequences for the patient.
Study objective
The purpose of our pilot study is to assess the status of the external rotator
muscles and tendons of the hip after the DAA, with prospective Magnetic
Resonance Imaging (MRI)
Study design
Observational pilot study
Study burden and risks
Estimated MRI scanning time is 30 minutes. Possible risks for the participants
are negligible, since MRI contains no radiation. Patients could get
claustrophobic. When this occur the scan is stopped immediately and the patient
will be excluded for the remaining study.
Sportlaan 600
Den Haag 2566 MJ
NL
Sportlaan 600
Den Haag 2566 MJ
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
Scheduled for uncemented total hip replacement with Direct Anterior Approach
Informed consent
Exclusion criteria
Medical condition that is a contra-indication for MRI, e.g. pacemaker, ICD, cochlear implants or claustrofobia
Mental disabilities
Language barrier
Previous hip surgery
Hip replacement with another approach than the DAA (direct lateral or posterolateral approach)
Hip prosthesis for treatment of hip fracture
Cemented hip prosthesis
Osteoarthritis of contralateral hip
Osteoarthritis of the knee
Inability to flex hip and knee 90 degrees ( for external rotation force measurement).
Design
Recruitment
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 | NL53707.098.15 |