The purpose of this study is to compare short-term postoperative recovery following THA between patients operated via the direct anterior approach and the posterior approach, using patient-reported and objective performance-based outcome measures.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameters will be the difference in clinical outcome, in
terms of PROMs, performance-based measures and levels of physical activity.
Secondary outcome
Secondary outcomes include operating time, blood loss, in hospital stay and
adverse events.
Background summary
Total hip arthroplasty (THA) is the most successful treatment for patients with
severe hip osteoarthritis (OA), and approximately 30.000 THA*s are performed in
The Netherlands annually. In general, 3 different surgical approaches can be
used to perform a THA: the posterior (i.e. posterolateral) approach, the
straight lateral approach and the direct anterior approach. In The Netherlands,
the posterolateral approach is most often used accounting for 56% of all THA*s
performed in 2017.
Over the recent years, the direct anterior approach has gained enormous
popularity. It was used for only 5% of all THA*s performed in 2010, but its use
has increased up to 27% of all THA*s performed 2017. The direct anterior
approach is advertised to result in faster postoperative recovery however there
is paucity of evidence to support this claim. A few studies have found marginal
differences in outcome only during the first three months after surgery, in
favour of the anterior approach (4-6). However, most studies comparing outcomes
after THA exclusively use patient-reported outcome measures (PROMs), which are
subjective measures dominated by pain and lack of discriminative capacity on a
functional level.
Study objective
The purpose of this study is to compare short-term postoperative recovery
following THA between patients operated via the direct anterior approach and
the posterior approach, using patient-reported and objective performance-based
outcome measures.
Study design
Single center randomised trial
Intervention
Patients will be randomised between the approach that will be used for THA. At
2 moments, patients will be subjected to wearing movementsensors on 4
consecutive days.
Study burden and risks
The participants in the study will be exposed to extra physical activities
during their clinical visit, including 4x10m fast-paced walking, 30 seconds of
sit-stand-sit movement and 30 seconds of step-up transfers. The inertial
measurement unit (IMU) will be attached at the dorsal side of the pelvis using
double-sided adhesive hypo-allergenic tape on the skin. Patients do not need to
undress. With regards to the activity monitor, it will be attached with the
same tape on the skin of the lateral thigh and it is worn underneath the
trousers for 4 consecutive days. In previous studies using the same methods and
materials, no adverse events have been reported.
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Listed location countries
Age
Inclusion criteria
- Patients undergo an elective THA for osteoarthritis;
- Patients are over 50 years of age at the time of surgery;
- Patients have a BMI less than 35;
- Patients have no previous other hip, knee or ankle joint arthroplasty;
(Charnley A and B1 class)
- 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 with a BMI above 35 at the time of surgery;
- Patients with an age below 50 at the time of surgery;
- Patients with a previous hip, knee or ankle arthroplasty.
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 | NL69512.075.19 |