Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)
NCT ID: NCT06342843
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
211 participants
INTERVENTIONAL
2024-03-26
2027-12-31
Brief Summary
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Detailed Description
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Study design: Multicenter, prospective, double blinded, randomized controlled intervention study in which the used operation method is not shared with the patient until one year after surgery and in which the study researcher is also blinded.
Study population: A total of 211 men and women, age ≥ 18 years, with symptomatic hip osteoarthritis in whom THA is indicated.
Intervention (if applicable): For this randomized controlled trial (RCT), patients will be randomly allocated in one of two groups: one group receives THA by using PLA, the other group receives THA by using DSA.
Main study parameters/endpoints: As primary outcome specifically the Hip Disability and Osteoarthritis Outcome Score- Physical Function Short Form (HOOS-PS) is used for the short-term HRQoL.
Secondary parameters/endpoints are split up into different categories. 1) HRQoL evaluation on the long term using patient reported outcome measures (PROMs) (NRS score, Short form-12 (SF-12), HOOS subscales, Global rating of change, and Euro Quality of Life questionnaire). 2) Physical function using physical functioning test (Timed Up and Go test, 40-meter self-paced walk test for hip osteoarthritis and Stair Climb Test). 3) Muscle atrophy measurements using CT scans. Muscle atrophy is expressed in both quantity of muscle volume loss and extend of fatty infiltration using the Goutallier scale. Component placement is measured in different angles. 4) Evaluation of a new metal artifact reduction technique for CT images. 5) Relationship between muscle atrophy and urinary incontinence after total hip replacement.
Other study parameters include preoperative demographics such as age and gender, perioperative data such as blood loss, use of analgetics, operation time and postoperative complications such as infection, aseptic loosening and dislocation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Posterolateral approach (PLA)
THA by using the posterolateral approach
Total Hip Arthroplasty
a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.
Direct superior approach (DSA)
THA using the direct superior approach
Total Hip Arthroplasty
a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.
Interventions
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Total Hip Arthroplasty
a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Isala
OTHER
Responsible Party
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Roelina Munnik, PhD
Researcher
Principal Investigators
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Harmen B. Ettema, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Isala
Locations
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Amphia
Breda, North Brabant, Netherlands
Isala
Zwolle, Overijssel, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Stefan BT Bolder, MD
Role: primary
Wierd Zijlstra, MD/PhD
Role: primary
Other Identifiers
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NL81395.075.22
Identifier Type: OTHER
Identifier Source: secondary_id
SPLAsH
Identifier Type: -
Identifier Source: org_study_id
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