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Osteoarthritis, HipSPLAsHNCT06342843

Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)

A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by Isala at 3 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Osteoarthritis, Hip
What is being tested?
Total Hip Arthroplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
3 sitesNetherlands
Study dates
26 Mar 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • Severe hip dysplasia
  • Cognitive impairment
  • Malignancies or metastases involving the hip joint or the nearby soft tissues
  • Inability to speak and write Dutch language

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Harmen Ettema, MD/PhD contact

0031886245656

h.b.ettema@isala.nl

Roelina Munnik-Hagewoud, PhD contact

0031886245375

r.munnik@isala.nl

Netherlands3 sites, 3 recruiting
  • Amphia

    Breda, North Brabant, 4818CK

    Stefan BT Bolder, MD

    Recruiting
  • Medisch Centrum Leeuwarden

    Leeuwarden, Provincie Friesland, 8934AD

    Wierd Zijlstra, MD/PhD

    Recruiting
  • Isala

    Zwolle, Overijssel, 8000 GK

    Diederik de Boer, MSc., 00316248117, die.de.boer@isala.nl

    Roelina Munnik, PhD, 00316245375, r.munnik@isala.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial

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.

Read the detailed description

Objective: The primary objective is to evaluate health related quality of life (HRQoL) after THA using the DSA compared to the golden standard PLA in patients with incapacitating hip osteoarthritis after two weeks. The secondary objectives are divided into 1) long-term HRQoL evaluation, 2) physical performance, 3) radiologic muscle atrophy and component placement of the THA, 4) validation of a new metal artifact reduction technique for CT, and 5) relationship urinary incontinence and muscle atrophy.

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.

Being tested
Total Hip Arthroplasty
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Total Hip ArthroplastyProcedure or surgery

    a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.

Study groups in NCT06342843
Study groupRoleWhat they receive
Posterolateral approach (PLA)Active comparatorTHA by using the posterolateral approach
Receives: Procedure: Total Hip Arthroplasty
Direct superior approach (DSA)Active comparatorTHA using the direct superior approach
Receives: Procedure: Total Hip Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form

    Evaluation symptoms and shortcomings in patients with hip complaints, 0-100 points, in which a higher score indicates less complaints

    Measured: pre-operatively and 2 weeks, 6 weeks, 3months and 12 months postoperatively

Secondary outcomes (21)
  1. Numeric Rating Scale (NRS)

    Pain scoring on a 10-point Likert scale: 0 no pain to 10 worst thinkable pain

    Measured: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

  2. Short Form-12 (SF-12)

    general health status, scored on 101-point Likert scale, 0 being worst health to 100 being ideal health

    Measured: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

  3. Hip disability and Osteoarthritis Outcome Score (HOOS)

    evaluates symptoms and shortcomings in patients with hip complaints 5-point Likert scale, in which a higher score means less symptoms

    Measured: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

  4. Euro Quality of Life (EQ-5D)

    measures health-related quality of life using 5 domains, questions scored on a 0-100 scale, the higher the score the better the quality of life

    Measured: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

  5. Global Rating of Change scale

    measures whether patient has improved or deteriorated over time to determine an effect of an intervention. It asks patients to assess their current health status compared to a previous time-point. 7 numerical values ranging from 7 (very much better) to 1 (very much worse)

    Measured: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

  6. Timed Up and Go test (TUG test)

    measures time it takes for an individual to stand up from an armchair, walk a distance of 3 meters, turn around, walk back and sit down. the quicker the better.

    Measured: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

  7. 40 meter self-paced walk test for hip osteoarthritis

    assesses the time it takes to walk 40 meters in patients with hip or knee osteoarthritis

    Measured: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

  8. Stair climb test

    measures the time an individual needs to ascend and descent a stair with 10 steps

    Measured: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

  9. Muscle atrophy by using Computer Tomography (CT) scanner

    Muscular atrophy of the short external rotator muscles will be measured absolutely in cm^3 using the Tumor Tracking Tool of Philip IntelliSpace Portal, version 9.0.

    Measured: pre-operatively and 12 months postoperatively

  10. Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR)

    Computer Tomography (CT) image of the pelvis and some slices at the height of the knee condyles. The scans will be reconstructed with a slice thickness of 0.9 of 1 mm and with an additional soft tissue filter. The pre-operative CT scans will be performed with a kilovoltage peak (kVp) of 120. The post-operative scans will be performed at 140 kVp, which helps to mitigate metal artifacts. In addition, the post-operative CT scans will be edited with metal artefact reduction for orthopedic implants (O-MAR; Philips Healthcare). All CT scans will be analyzed on a 23.8-inch Liquid-crystal display (LCD) monitor with a resolution of 1920x1080 pixels.

    Measured: pre-operatively and 12 months postoperatively

  11. Postoperative cup position on Computer Tomography (CT) image

    The initial abduction/inclination of the cup, angle α, is measured on a coronal Computer Tomography (CT) image with respect to the ischial bone, which is used as internal reference. The anterior opening angle of the cup (angle β) is measured on the axial slice at the middle of the head of the prosthesis in which the posterior acetabulum is used as an internal reference. The angle of the neck of the prosthesis relative to the horizontal plane, angle a, is measured in the coronal slice containing the thickest diameter of the neck and is also measured with respect to the ischial bone. The anteversion angle of the neck around the vertical axis, angle b, is measured in the axial slice containing the greatest diameter of the neck with respect to the posterior acetabulum.

    Measured: 12 months postoperatively

  12. Comparing definite cup position with preoperative planned cup position

    The initial abduction/inclination of the cup, angle α, is measured with respect to ischial bone, which is used as internal reference. The anterior opening angle of cup (angle β) is measured on axial slice at the middle of the head of the prosthesis in which the posterior acetabulum is used as internal reference. The angle of the neck of the prosthesis relative to the horizontal plane, angle a, is measured in coronal slice containing the thickest diameter of the neck and is measured with respect to ischial bone. The anteversion angle of the neck around the vertical axis, angle b, is measured in the axial slice Pre-operative hip component planning will be conducted using X-ray and CT images. Regarding component planning, the use of X-ray is sufficient. 3D planning using CT images will be performed retrospectively. Cup position will be compared between the 2D and 3D planning and with the definite positions

    Measured: pre- operatively and 12 months postoperatively

  13. Comparing definite component position with surgeon's perioperative estimation of component position

    The surgeon writes a report of the performed procedure in which the estimated and targeted degrees inclination of the cup and degrees anteversion of the cup and stem are noted. Results will be compared to the component positions as measured on the postoperative CT scan.

    The initial abduction/inclination of the cup, angle α, is measured with respect to ischial bone, which is used as internal reference. The anterior opening angle of the cup (angle β) is measured on the axial slice at the middle of the head of the prosthesis in which posterior acetabulum is used as an internal reference. The angle of the neck of the prosthesis relative to the horizontal plane, angle a, is measured in the coronal slice containing the thickest diameter of the neck and is also measured with respect to the ischial bone. The anteversion angle of the neck around the vertical axis, angle b, is measured in the axial slice containing the greatest diameter of the neck with respect to the posterior acetabulum.

    Measured: direct postoperative and 12 months postoperatively

  14. overall image quality

    Images will be edited by deep-learning metal artifact reduction technique (DL-MAR) and by O-MAR. The post-surgery images with and without O-MAR and the images with DL-MAR will be scored by four radiologists. During this assessment, the radiologist will also have access to the pre-surgery Computer Tomography (CT) scans. The images with and without O-MAR and with DL-MAR will be scored by the radiologists using a five-point scale. The images will be scored on: overall image quality. A five point scale with score 1-5 will be used, including very poor (1), poor (2), fair (3), good (4) and excellent (5).

    Measured: pre- operatively and 12 months postoperatively

  15. image diagnostic confidence

    Images will be edited by deep-learning metal artifact reduction technique (DL-MAR) and by O-MAR. The post-surgery images with and without O-MAR and the images with DL-MAR will be scored by four radiologists. During this assessment, the radiologist will also have access to the pre-surgery Computer Tomography (CT) scans. The images with and without O-MAR and with DL-MAR will be scored by the radiologists using a five-point scale. The images will be scored on: 1) diagnostic confidence for bone, 2) diagnostic confidence for muscle, 3) diagnostic confidence for pelvic organs. a five point scale with score 1-5 will be used, including very poor (1), poor (2), fair (3), good (4) and excellent (5).

    Measured: pre- operatively and 12 months postoperatively

  16. metal artifacts on images

    Images will be edited by deep-learning metal artifact reduction technique (DL-MAR) and by O-MAR. The post-surgery images with and without O-MAR and the images with DL-MAR will be scored by four radiologists. During this assessment, the radiologist will also have access to the pre-surgery Computer Tomography (CT) scans. The images with and without O-MAR and with DL-MAR will be scored by the radiologists using a five-point scale. The images will be scored on: severity of metal artifacts. a five-point scale including severe (1), pronounced (2), moderate (3), mild (4) and none (5) will be used.

    Measured: pre- operatively and 12 months postoperatively

  17. Incontinence Severity Index (ISI)

    this index consists of two questions about the frequency and the quantity of urinary incontinence (92). The value of each question will be multiplied. A higher score means more severe urinary incontinence.

    Measured: pre-operatively and 6 weeks and 12 months postoperatively

  18. Urinary Distress Inventory, Short Form (UDI-6)

    the UDI-6 consists of six items about the experiences with several symptoms and to what degree the patients bothers (93). A four-point Likert scale is used in the degree part (1 = not at all - 4 = greatly.). Total score is used as outcome. A higher total score means a higher disability.

    Measured: pre-operatively and 6 weeks and 12 months postoperatively

  19. Patient Global Impression of Severity (PGIS)

    one question about the severity of the urinary incontinence (94). A four-point Likert scale is used (1 = none - 4 = severe).

    Measured: pre-operatively and 6 weeks and 12 months postoperatively

  20. Incontinence Impact Questionnaire Short Form (IIQ-7)

    the IIQ-7 consists of seven items on the impact of urinary incontinence on activities, participation in daily life, social contacts and emotional status (93). A four-point Likert scale is used (1 = not at all - 4 = greatly.). A higher total score means a bigger impact.

    Measured: pre-operatively and 6 weeks and 12 months postoperatively

  21. Incontinence after Total Hip Arthroplasty

    this customized question concerns the opinion of the subject if urinary incontinence is changed after the total hip arthroplasty. This question will only be administered at six weeks and one year postoperatively.participation in daily life, social contacts and emotional status (93). A four-point Likert scale is used (1 = not at all - 4 = greatly.). A higher total score means a bigger impact.

    Measured: 6 weeks and 12 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start26 Mar 2024
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, prospective, double blinded, randomized controlled intervention study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
211 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342843
Sponsor's protocol ID
SPLAsH
Other IDs
NL81395.075.22
Acronym
SPLAsH
Status last verified
Jul 2025
First submitted
28 Feb 2024
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by Isala at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harmen Ettema, MD/PhD (0031886245656, h.b.ettema@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (time frame: pre-operatively and 2 weeks, 6 weeks, 3months and 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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