With this study we will be able to determine whether the DAA has better short-term results compared to the PLA in THA whilst improving patient outcome and reducing costs for hospitals and society as a whole.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome parameters
Disability, functioning during daily living, recreational activities and sports
(Hip dysfunction and Osteoarthritis Outcome Score) will be assessed
preoperatively and at 6 weeks, 3 months, 6 months, 12 months, and 24 months
after surgery.
Secondary outcome
Clinical outcome parameters
Perceived pain is assessed preoperatively and during the first 3 days after
surgery (VAS pain). Length of hospital stay is registered. Quality of Life
(EQ-5D), perceived pain and symptoms, and complications are assessed
preoperatively and at 6 weeks, 3 months, 6 months, 12 months, and 24 months
after surgery.
Functional outcome parameters
Quality of walking will be assessed preoperatively and at 1 year after surgery
during a timed up and go test and a two times 50m walk using inertial sensors.
Surgical outcome parameters
Operation time, blood loss, and other relevant parameters in relation to the
surgical procedures are registered. The cup and stem positioning are assessed
using standard radiography in the first (hospital) days after surgery and at 1
year after surgery. A small subgroup of patients will undergo a CT or MRI scan.
Cost-effectiveness
Productivity costs, direct medical costs (costs of additional radiography,
medical consumption) are assessed using questionnaires at 0, 3, 6, 9 and 12
months after surgery.
Background summary
Total hip arthroplasty (THA) is a surgical procedure in which the hip joint is
totally replaced by a prosthetic implant and is one of the most frequently
performed orthopaedic operations. There are several surgical techniques to
approach the hip joint which differ in incision placement, tissue damage and
postoperative management. The Direct Anterior Approach (DAA) is used more and
more in performing THA. By using the DAA no muscles are damaged. There are
indications in literature that this results in a shorter length of stay in the
hospital, higher patient satisfaction and better cost-effectiveness when
compared to the more standard Posterolateral Approach (PLA). The PLA requires a
surgeon to detach several muscles before reaching the hip joint. This study
aims to compare the clinical, functional and surgical outcome and
cost-effectiveness of the DAA when compared to the PLA in total hip
arthroplasty. The proposed study is a single centre, parallel group randomised
clinical trial with balanced randomisation (1:1), and with a follow-up of one
year after surgery. 120 patients aged over 18 years, suffering of
osteoarthritis of the hip, who are a candidate for uncemented total hip
arthroplasty will be included. The clinical outcome is defined in terms of pain
and function of the hip in relation to different activities of daily life.
Functional outcome will be assessed using several validated questionnaires.
Surgical outcome, including operation time and blood loss, will be evaluated. A
cost-effectiveness analysis and budget impact analysis will be performed.
Study objective
With this study we will be able to determine whether the DAA has better
short-term results compared to the PLA in THA whilst improving patient outcome
and reducing costs for hospitals and society as a whole.
Study design
The proposed study is a single centre, with balanced randomisation (1:1),
parallel group, partly single blinded, superiority study with a follow-up of 24
months after surgery conducted in Northwest Clinics Alkmaar.
Intervention
The intervention studied in the proposed project is the direct anterior
approach (DAA) for total hip replacement surgery. The DAA is compared to the
more standard used posterolateral approach (PLA). All operations are performed
by three surgeons using a standard operating table. For the DAA, the patient is
placed in a supine position. The hip capsule is reached from the front,
utilizing the internervous plane, located between the sartorius muscle and
tensor fascia latae muscle superficially, and between the rectus femoris muscle
and gluteus medius muscle more profoundly. For the PLA, the patient is placed
in the lateral position. The hip capsule is reached from the back, after
incising the tensor fascia latae muscle and gluteal fascia, blunt dissection of
the gluteus maximus muscle, and releasing the insertions of the piriformis,
gemelli and obturator externus tendons.
For all operations the same hip prosthesis (Corail Hip System, DePuy Synthes,
Warsaw, Indiana, United States of America) will be used, the size of which is
chosen in accordance with the anatomical characteristics of each patient. If
due to management decision there will be a change in prosthesis supplier,
patients may be treated with the Polar total hip system (Smith and Nephew,
Warsaw Indiana, united States of America). This stem has a similar tapered
design.
Study burden and risks
Considering the fact that both intervention and control treatment are currently
being performed as part of normal treatment procedures without any known
increased risks for patients, we expect that the risk of participating in this
study will be minimal. The burden of participating will consist of filling in
questionnaires and undergoing walking test, and for a small number of patients
(2x15) undergoing a CT or MRI scan, both regularly performed examinations.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
Inclusion criteria
• Willing and able to participate in the study protocol;
• Age between 18 and 80 years
• ASA Physical Status I, II and III
• Diagnosed with osteoarthritis of the hip
• Subjects for who it is decided that they will undergo an uncemented THA at
Northwest Clinics Alkmaar
Exclusion criteria
• Patients with previous surgery to the ipsilateral or controlateral hip;
• Patients with posttraumatic changes of the pelvis or femur;
• Patients with inflammatory arthropathies;
• Patients diagnosed with osteoporosis
• Patients diagnosed with rheumatoid arthritis
• Patients who suffer from insulin dependant diabetes
• Patients who lack understanding of the Dutch language
• Patients who are treated for or diagnosed with neurological or muscle
disorders which make assessment of pain and gait not possible
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 | NL48411.094.14 |