The primary objective is to evaluate health related quality of life (HRQoL) after total hip arthroplasty using the DSA compared to the golden standard (PLA) in patients with incapacitating hip osteoarthritis after two weeks. The secondary objectives…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
As primary outcome specifically the Hip Disability and Osteoarthritis Outcome
Score- Physical Function Short Form (HOOS-PS) is used.
Secondary outcome
Secondary parameters/endpoints are split up into different categories. 1) HRQoL
evaluation on the long term using PROMS (NRS score, Short form-12, HOOS
subscales, Global rating of change, and Euro Quality of Life questionnaire). 2)
physical function using physical functioning test (Timed Up and Go test and
40-meter self-paced walk test for hip osteoarthritis. 3) muscle atrophy
measurements using CT-scans. Muscle atrophy is expressed in both quantity of
muscle volume loss and the extend of fatty infiltration using the Goutallier
scale. Component placement is measured in different angles.
Other study parameters include preoperative demographics such as age and
gender, perioperative data such as blood loss, use of analgetics, operation
time and postoperative complications such as infection, aseptic loosening and
dislocation.
Background summary
In the field of total hip arthroplasty (THA) the posterolateral approach (PLA)
remains the golden standard. However, nowadays new minimally invasive operating
techniques emerge. One of them being the Direct Superior Approach (DSA) in
which damage to the iliotibial tract and exorotatory muscles is minimalized.
Recent small studies suggest rapid muscle repair in using DSA compared to PLA 4
weeks after surgery. However, only a short RCT has compared the DSA with the
PLA and found possible shorter muscular recover and less bloodloss in favor to
the DSA. However, patient*s experience on short and long term after having
surgery using the DSA technique has not been compared to the PLA technique
properly yet. These days it gets more and more important for patients to be on
their feet as soon as possible. Due to the minimal invasive character of the
DLA it is important to investigate its possible benefits in comparison to the
PLA.
Study objective
The primary objective is to evaluate health related quality of life (HRQoL)
after total hip arthroplasty using the DSA compared to the golden standard
(PLA) in patients with incapacitating hip osteoarthritis after two weeks. The
secondary objectives are divided into 1) long term HRQoL evaluation, 2)
physical performance, 3) radiologic muscle atrophy and component placement of
the THA, 4) validation of a new metal artifact reduction technique for CT and
5) relationship between muscle atrophy and incontinence after placement of the
THA
Study design
Multi center (Isala Zwolle, Medical Center Leeuwarden and Amphia hospital
Breda), double blinded, randomized controlled intervention study in which the
used operation method is not shared with the patient.
Study burden and risks
There is no extended burden or risk associated with patients for this trial
since both of these operation techniques are already performed in regular care.
For this RCT, patients come to the outer patient department for regular
follow-up according to local protocol 6 weeks and 1 year after surgery with
X-rays. Additionally, a follow-up visit after two weeks is scheduled. During
these three follow-up moments, patients will be asked to fill in questionnaires
and have several physical tests performed. Patients included in Isala Zwolle
will be asked to have an additional CT-scan preoperatively and postoperatively
to measure muscle atrophy and cup placement. This study will contribute to
demonstrating the minimally invasive character of the DSA technique.
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Dr. Van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
- Symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA)
is indicated
- Ageing 18 years and older at time of study entry
- Competent and able to participate in follow-up
Exclusion criteria
- Previous ipsilateral hip surgery
- BMI >35 kg/m2
- Controlateral incapacitating coxarthrosis
- Neurological conditions influencing walking pattern
- Inability to walk without walking aid preoperatively
- Rheumatoid arthritis (RA)
- Severe hip dysplasia
- Cognitive impairment
- Inability to speak and write Dutch language
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 |
|---|---|
| ClinicalTrials.gov | NCT06342843 |
| CCMO | NL81395.075.22 |