Direct Superior approach versus PosteroLateral Approach in total Hip arthroplasty:;a multicenter randomized controlled trial

Conditions: coxarthrosis
10005944
hip athrosis

Registration Number: NL-OMON51460

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 207

Inclusion Criteria

- Symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA)
is indicated
- Ageing 18 years and older at time of study entry
- Competent and able to participate in follow-up

Exclusion Criteria

- Previous ipsilateral hip surgery
- BMI >35 kg/m2
- Controlateral incapacitating coxarthrosis
- Neurological conditions influencing walking pattern
- Inability to walk without walking aid preoperatively
- Rheumatoid arthritis (RA)
- Severe hip dysplasia
- Cognitive impairment
- Inability to speak and write Dutch language

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>As primary outcome specifically the Hip Disability and Osteoarthritis Outcome<br /><br>Score- Physical Function Short Form (HOOS-PS) is used for the short term<br /><br>patient satisfaction. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters/endpoints are split up into different categories. 1)<br /><br>patient satisfaction evaluation on the long term using PROMS (NRS score, Short<br /><br>form-12, HOOS subscales, Global rating of change, and Euro Quality of Life<br /><br>questionnaire). 2) physical function using physical functioning test (Timed Up<br /><br>and Go test, 40-meter self-paced walk test for hip osteoarthritis and steps<br /><br>counting app). 3) muscle atrophy measurements using CT-scans. Muscle atrophy is<br /><br>expressed in both quantity of muscle volume loss and the extend of fatty<br /><br>infiltration using the Goutallier scale. Cup placement is measured in different<br /><br>angles.<br /><br>Other study parameters include preoperative demographics such as age and<br /><br>gender, perioperative data such as blood loss, use of analgetics, operation<br /><br>time and postoperative complications such as infection, aseptic loosening and<br /><br>dislocation. </p><br>