Primary objective:Assess whether there is a measurable difference in the GRF in the early phase after THA with regard to gait between the DSA and the PLA.Secondary objectiveShow whether there are differences in parameters present from the gait…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage difference in load of the affected / operated leg compared to
the unaffected leg, while walking at 3 km / h, at 4 weeks after the THA. This
is determined by dividing the average ground reaction force during the stance
phase of the operated leg by the mean ground reaction force during the stance
phase of the non-operated leg.
Primary outcome variable (s):
The average ground reaction force (GRF) during the stance phase of the operated
leg is divided by the average ground reaction force during the stance phase of
the non-operated leg. The average of this is calculated on the number of steps
that are run during 1 minute walk at 3 km / h. This primary outcome measure
between the two groups is then compared with an unpaired t-test, assuming that
the data will be normally distributed. This concerns the differences at the
4-week measurement moment.
Secondary outcome
As secondary outcome measures are assessed:
* GRF symmetry at 8 and 12 weeks
* Trunk sway on all 3 GRAIL moments
* Pelvic lifts all 3 GRAIL moments
* Hip and knee ROM during the walk on all 3 GRAIL moments
* Internal / External rotation ROM of the hip on all 3 GRAIL moments
* Hip abductor moment on all 3 GRAIL moments
* EMG differences affected versus unaffected side during stance (gluteus
maximus, gluteus medius and tensor fascia lata) on all 3 GRAIL moments
* Cadence / step length on all 3 GRAIL moments
* Gait width on all 3 GRAIL moments
* Performance at obstacle avoidance task at all 3 GRAIL moments
* Preferred walking speed on all 3 GRAIL moments
* Change in Patient Reported Outcome MeasureS (PROMS) from pre-operative to 3
months (see 5.2.3: questionnaires)
* Course in NumeRic Scal for pain (NRS) score
Tertiary parameters
* The use of tools during the recovery period
* AEs and SAEs, which are requested during the GRAIL moments.
Secondary outcome variable (s)
With regard to the GRF symmetry at the other measurement moments (8 and 12
weeks): these will be calculated in the same way as the primary outcome measure
and the difference between the groups will also be tested at any time with an
unpaired t-test.
Also the 'trunk sway', 'pelvic tilt', 'hip ROM sagittal plane', 'knee ROM
sagittal plane', 'Internal / extarnal rotation ROM hip', 'Hip abductor moment',
'EMG differences between affected non-affected side' , 'step frequency /
cadence', and 'gait width' are calculated as an average over 1 minute walk at 3
km / h.
The preferred walking speed is determined by setting the treadmill with the
patient in such a way that he / she walks the most comfortably. The performance
on the obstacle avoidance task is evaluated by counting how often the patient
walks on the projected surfaces in 4 minutes on the treadmill, which we again
evaluate at 3 km / h.
We will analyze the parameters in the two paragraphs above with two-way
repeated measures ANOVAs with the 3 time moments as 'within-subjects' factor
and the groups as 'between-subjects' factor.
Evaluation of the PROMS data will be analyzed in the same way, but with
baseline and 3 months as the time moments. We will compare the occurrence of
AEs related to the prosthesis placement and SAEs between the two groups using a
Fisher's Exact test.
Background summary
The Total Hip Arthroplasty: (THA) is one of the most successful orthopaedic
surgeries. The aim of the operation is to eliminate the pain and disability
connected to a osteoarthritis of the hip, allowing patients to function
independently again. However, the clinical results of the minimally invasive
techniques vary on these outcome measure. Several studies with different
minimal invasive approaches show hardly significant differences with regard to
gait in later recovery phases. If there are any significant differences at all,
these are demonstrated in the early phase after THA.
In recent years, several new minimally invasive techniques have been developed
to implement the THA. The goal of these minimally invasive approaches is to
reduce muscle damage during surgery on the hip, which would reduce
postoperative pain and improve postoperative recovery.
One of the latest minimally invasive techniques is the Direct Superior Approach
(DSA). This is a posterior approach to saving tissue comparing to the standard
Postero-Lateral Approach (PLA) leaving the iliotibial band intact. In theory,
this approach would reduce postoperative pain, and the functional recovery
would show a faster recovery towards normal gait. However, this has not been
investigated yet.
Study objective
Primary objective:
Assess whether there is a measurable difference in the GRF in the early phase
after THA with regard to gait between the DSA and the PLA.
Secondary objective
Show whether there are differences in parameters present from the gait analysis
performed using the GRAIL between the DSA and PLA at THA.
Study design
The study starts with the mapping of some demographic data. If patients are
eligible on the basis of the in / exclusion criteria, they are approached for
the study. After informed consent they are randomized in the PLA or DSA group.
Patients are randomized on the basis of randomization where the researcher and
patient do not know which treatment has been received.
The operators are the same in both groups. Both approaches have been used for 2
years. The operators who execute the DSA do both the DSA approach and the
standard posterior approach on a regular basis. In a previous analysis it was
shown that the DSA approach was introduced safely and without a learning curve
in Amphia Hospital. The operators who perform the procedure in this study do
both procedures on a regular basis and have had experience with them for a long
time without the effect of a learning curve. Since both approaches will be
applied by the same orthopedic surgeons in this study, there is no influence of
the therapist / orthopedic surgeon.
After 4, 8 and 12 weeks postoperatively, a gait analysis will be performed on
the GRAIL. These measurements are not standard and are therefore carried out
purely for the sake of this research. Furthermore, standard questionnaires are
taken preoperatively and postoperatively after 3 months in regular care.
Study burden and risks
The risks for patients in participating in this study are negligible. Both
approaches for the hip operation are currently being used as "usual care". The
gait analysis on the GRAIL does not involve more risks than the movements they
perform in daily life, even in the phase shortly after the THA operation. By
way of illustration: patients are usually encouraged to get on their feet a few
hours after the operation and a large proportion of the patients go home the
same day or the day after knowing that walking is going well. The total
measurement using the GRAIL will take about 60 minutes, with only 10-15 minutes
being walked.
During the gait analysis they will walk on a treadmill at a speed of 3 km / h,
where they are stuck in a fall harness. This speed has been chosen because it
is easy to achieve for everyone and will therefore not be an obstacle. They get
the instruction (especially relevant at 4 weeks) not to stick to the handles,
only when they feel anxious / unstable. At the same time, the obstacle
avoidance task within the GRAIL entails almost no risks, since these are only
light projections. Stepping on such an obstacle will therefore not have any
further consequences.
Benefits for patients with participation are not demonstrable, except that the
patient may be more actively involved in recovery after the operation, which
may offer benefits.
Molengracht 21
Breda 4818CK
NL
Molengracht 21
Breda 4818CK
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing total hip arthroplasty for osteoarthritis
Patients with a BMI <35
Exclusion criteria
Patients who have undergone a previous joint replacement surgery of the lower body in the past year
Patients with a BMI>35
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL66078.100.18 |
| OMON | NL-OMON29294 |