No registrations found.
ID
Source
Brief title
Health condition
Direct anterior approach, DAA, cost-effectiveness, posterolateral, total hip arthroplasty, THA, minimal invasive,
Heuter
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hip pain and symptoms assessed using the symptoms, pain and activities of daily living (ADL) subscales of the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS) after three months
Perceived pain in the week before the moment of assessment, assessed using a Visual Analogue Scale (VAS) after three months
Secondary outcome
Hip pain and symptoms assessed using the sports & recreation and quality of life subscales of the Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
Length of hospital stay
Quality of life assessed using the EQ-5D
Functioning during daily living assessed using the HOOS
Quality of walking assessed during a timed up and go test and a two times 50m walk using inertial sensors
Operation time, blood loss, and other parameters of the surgical procedures
Cup and stem positioning assessed using standard radiography
Cost-Effectiveness assessed using the cost-questionnaire
Muscle status assessed using MRI in a sample of 15 patients from each group
Positioning of the implant assessed using CT scans in a sample of 15 patients from each group.
All complications related to the surgery and rehabilitation
Productivity costs
Direct medical costs (costs of additional radiography, medical consumption)
Study design
Follow up visit at 6 weeks and 12 months
questionnaires at 6 weeks 3 6 9 12 and 24 months
Intervention
Posterolateral approach total hip arthroplasty versus direct anterior THA
CORAL – Center for Orthopaedic Research Alkmaar
Wilhelminalaan 12
Alkmaar 1815 JD
The Netherlands
+31 72 5484342
coral@mca.nl
CORAL – Center for Orthopaedic Research Alkmaar
Wilhelminalaan 12
Alkmaar 1815 JD
The Netherlands
+31 72 5484342
coral@mca.nl
Inclusion criteria
Willing and able to participate in the study protocol;
Age between 18 and 80 years
ASA Physical Status I & II
Diagnosed with osteoarthritis of the hip
Subjects for who it is decided that they will undergo an uncemented THA at Medical Centre Alkmaar.
Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
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 |
|---|---|
| NTR-new | NL4814 |
| NTR-old | NTR5086 |
| Other | De Medisch Ethische Toetsingscommissie (METC) Noord-Holland : MedischcentrumAlkmaar |