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Total hip arthroplasty by direct anterior approach versus posterolateral approach. A randomized clinical trial.

Total hip arthroplasty by direct anterior approach versus posterolateral approach. A randomized clinical trial. - DANTE trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35973
Enrollment
120
Registered
2011-09-13
Start date
2012-02-17
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

degenerative hip disease Osteoarthritis of the hip

Interventions

Total hip arthroplasties (THA) will be performed by the department of orthopedic surgery in the Isala Clinics, Zwolle (The Netherlands). 120 THA's will be performed in total, of which 60 by posterol

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Mentally competent men and women with debilitating osteoarthritis of the hip indicated for a total hip arthroplasty - Signed informed consent - Age older than 18 years

Exclusion criteria

Exclusion criteria: - BMI > 35 - Contralateral hipprosthesis - Contralateral , debilitating osteoarthritis of the hip - Standard contraindications, as prevailing for elective total hip arthroplasty (pregnancy, infection and severe comorbidity of pulmonary, cardiac or metabolic nature)

Design outcomes

Primary

MeasureTime frame
Patient satisfactory with HOOS-functioning in daily life subscale 6 weeks postoperative as primary outcome. The definition of success (superiority) for the individual patient is: a clinical relevant difference is defined as 10 points or more at the HOOS-functioning in daily life subscale.

Secondary

MeasureTime frame
Besides the other 4 HOOS-subscales and HOOS total score, the following secundary outcomes will be used to evaluate effectivity of both approaches: - VAS pain en VAS satisfaction - SF-36 - Clinical data: blood loss, surgery time, incision length, length of hospital stay - Radiological: version and inclination cup, version and varus/valgus stem - Complications: bleeding, infection, dislocation, meralgia paraesthetica, venous thromboembolism and loosening Simultaneously course in time of HOOS, VAS en SF36 will be analysed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)