NCT06342843 Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)
| NCT ID | NCT06342843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Isala |
| Condition | Osteoarthritis, Hip |
| Study Type | INTERVENTIONAL |
| Enrollment | 211 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 211 participants in total. It began in 2024-03-26 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Harmen B. Ettema, MD/PhD
PRINCIPAL INVESTIGATOR
Isala
Frequently Asked Questions
Who can join the NCT06342843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Osteoarthritis, Hip. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06342843 currently recruiting?
Yes, NCT06342843 is actively recruiting participants. Contact the research team at h.b.ettema@isala.nl for enrollment information.
Where is the NCT06342843 trial being conducted?
This trial is being conducted at Breda, Netherlands, Zwolle, Netherlands, Leeuwarden, Netherlands.
Who is sponsoring the NCT06342843 clinical trial?
NCT06342843 is sponsored by Isala. The principal investigator is Harmen B. Ettema, MD/PhD at Isala. The trial plans to enroll 211 participants.