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Comparison Of Posterolateral and direct Anterior approach in uncemented total hip arthroplasty: treatment outcome and cost-effectiveness


- candidate number21776
- NTR NumberNTR5086
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2015
- Secondary IDsMedischcentrumAlkmaar De Medisch Ethische Toetsingscommissie (METC) Noord-Holland
- Public TitleComparison Of Posterolateral and direct Anterior approach in uncemented total hip arthroplasty: treatment outcome and cost-effectiveness
- Scientific TitleComparison Of Posterolateral and direct Anterior approach in uncemented total hip arthroplasty: treatment outcome and cost-effectiveness
- ACRONYMCOPA study
- hypothesis
- Healt Condition(s) or Problem(s) studiedTotal Hip Arthroplasty, Minimally invasive, Cost-effectiveness
- 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2015
- planned closingdate1-mrt-2019
- Target number of participants172
- InterventionsPosterolateral approach total hip arthroplasty versus direct anterior THA
- 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)
- TimepointsFollow up visit at 6 weeks and 12 months
questionnaires at 6 weeks 3 6 9 12 and 24 months
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES CORAL Center for Orthopaedic Research Alkmaar
- CONTACT for SCIENTIFIC QUERIES CORAL Center for Orthopaedic Research Alkmaar
- Sponsor/Initiator Noordwest Ziekenhuisgroep
- Funding
(Source(s) of Monetary or Material Support)
Foreest instituut
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD10-mrt-2015 - 25-apr-2015


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