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Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial
Led by Isala · Updated on 2025-08-03
211
Participants Needed
3
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are comparing two surgical methods for total hip arthroplasty (THA) in patients with disabling hip osteoarthritis: the posterolateral approach (PLA), considered the standard, and the direct superior approach (DSA). This study aims to assess differences in postoperative pain, health-related quality of life (HRQoL), physical function, rehabilitation, urinary incontinence, muscle atrophy, and implant positioning. A new CT imaging technique to reduce metal artifacts will also be evaluated. Participants will be randomly assigned to receive THA via either the PLA or DSA method. Both groups undergo surgery followed by assessments at multiple timepoints: before surgery, and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months afterward. The study includes a double-blind design where neither patients nor researchers know the surgical method used until one year post-surgery. CT scans will be used to measure muscle atrophy, implant positioning, and to validate the new imaging technique. During the study, participants will complete various physical function tests and questionnaires assessing pain, quality of life, and urinary incontinence at scheduled visits. Muscle atrophy and implant placement will be examined with CT scans preoperatively and at 12 months postoperatively. Researchers will also monitor for complications such as infections or dislocations. The primary outcome focuses on physical function measured by the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) over one year.
CONDITIONS
Brief Title
Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has symptomatic incapacitating coxarthrosis confirmed by physical exam and pelvic/hip X-ray requiring total hip arthroplasty
- Has signed informed consent
- Is aged 18 years or older at study entry
- Is competent and able to participate in follow-up
You will not qualify if you...
- Previous surgery on the same hip
- Body mass index (BMI) over 35 kg/m2
- Contralateral incapacitating coxarthrosis confirmed by physical exam and pelvic/hip X-ray
- Neurological conditions affecting walking pattern
- Unable to walk without aid before surgery
- Rheumatoid arthritis
- Severe hip dysplasia
- Cognitive impairment
- Malignancies or metastases involving the hip or nearby soft tissues
- Unable to speak and write Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and initial recovery period
Participants undergo total hip arthroplasty using either the direct superior approach or the posterolateral approach.
1 surgical visit (in-person)
Duration - 12 months
Participants attend follow-up visits to assess health-related quality of life, physical function, muscle atrophy, component placement, and urinary incontinence after surgery.
Visits at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively (in-person)
Trial Site Locations
Total: 3 locations
1
Amphia
Breda, North Brabant, Netherlands, 4818CK
Actively Recruiting
2
Isala
Zwolle, Overijssel, Netherlands, 8000 GK
Actively Recruiting
3
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands, 8934AD
Actively Recruiting
Research Team
H
Harmen Ettema, MD/PhD
R
Roelina Munnik-Hagewoud, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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