Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)
Recruiting · NCT06342843 · Interventional (participants receive a specific treatment) · Lead sponsor: Isala
View the official record on ClinicalTrials.gov →Interventions studied
Total Hip Arthroplasty
What this trial is about
This study will compare postoperative pain, health related quality of life (HRQoL), function, rehabilitation, urinary incontinence, muscle atrophy and component positioning in total hip arthroplasty (THA) using the posterolateral approach (PLA) or the direct superior approach (DSA). In addition, the CT images will be used to validate a new metal artefact reduction technique.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Subject
- Has symptomatic incapacitating coxarthrosis in whom total hip arthroplasty (THA) is indicated, diagnosed by both physical examination and pelvic/hip X-ray
- Has signed informed consent
- Is ageing 18 years or older at time of study entry
- Is competent and able to participate in follow-up
Exclusion criteria
- Previous ipsilateral hip surgery
- BMI \>35 kg/m2
- Contralateral incapacitating coxarthrosis, diagnosed by both physical examination and pelvic/hip X-ray
- Neurological conditions influencing walking pattern
- Inability to walk without walking aid preoperatively
- Rheumatoid arthritis (RA)
- Severe hip dysplasia
- Cognitive impairment
- Malignancies or metastases involving the hip joint or the nearby soft tissues
- Inability to speak and write Dutch language
Where it is running
3 locations listed.
- Amphia - Breda, North Brabant, Netherlands
- Isala - Zwolle, Overijssel, Netherlands
- Medisch Centrum Leeuwarden - Leeuwarden, Provincie Friesland, Netherlands