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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28364
Enrollment
172
Registered
2015-03-10
Start date
2015-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Direct anterior approach, DAA, cost-effectiveness, posterolateral, total hip arthroplasty, THA, minimal invasive, Heuter

Interventions

Posterolateral approach total hip arthroplasty versus direct anterior THA

Sponsors

Medisch centrum Alkmaar
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
 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

MeasureTime frame
 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)

Contacts

Public ContactCORAL – Center for Orthopaedic Research Alkmaar

Medical Centre Alkmaar - Department of Orthopaedics

coral@mca.nl+31 72 5484342

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)