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.
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.
Netherlands3 sites, 3 recruiting
- 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
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.
- Conditions
- Osteoarthritis, Hip
- 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 group | Role | What they receive |
|---|---|---|
| Posterolateral approach (PLA) | Active comparator | THA by using the posterolateral approach Receives: Procedure: Total Hip Arthroplasty |
| Direct superior approach (DSA) | Active comparator | THA 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted2 Apr 2024
- Study start26 Mar 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roelina Munnik, PhD, Isala
- Investigators
- Harmen B. Ettema, MD/PhD, Principal investigator, Isala
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06342843
- Acronym / sponsor ID
- SPLAsH / SPLAsH
- Conditions
- Osteoarthritis, Hip
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 211 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- multicenter, prospective, double blinded, randomized controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| Posterolateral approach (PLA) | Active comparator | Procedure: Total Hip ArthroplastyTHA by using the posterolateral approach |
| Direct superior approach (DSA) | Active comparator | Procedure: Total Hip ArthroplastyTHA using the direct superior approach |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Hip Arthroplastya surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components. | Procedure or surgery | Direct superior approach (DSA), Posterolateral approach (PLA) |
Primary outcome
Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form
Time frame: pre-operatively and 2 weeks, 6 weeks, 3months and 12 months postoperatively
Evaluation symptoms and shortcomings in patients with hip complaints, 0-100 points, in which a higher score indicates less complaints
21 secondary outcomes
Numeric Rating Scale (NRS)
Time frame: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively
Short Form-12 (SF-12)
Time frame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Hip disability and Osteoarthritis Outcome Score (HOOS)
Time frame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Euro Quality of Life (EQ-5D)
Time frame: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively
Global Rating of Change scale
Time frame: pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively
Timed Up and Go test (TUG test)
Time frame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
40 meter self-paced walk test for hip osteoarthritis
Time frame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Stair climb test
Time frame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Muscle atrophy by using Computer Tomography (CT) scanner
Time frame: pre-operatively and 12 months postoperatively
Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR)
Time frame: pre-operatively and 12 months postoperatively
Postoperative cup position on Computer Tomography (CT) image
Time frame: 12 months postoperatively
Comparing definite cup position with preoperative planned cup position
Time frame: pre- operatively and 12 months postoperatively
Comparing definite component position with surgeon's perioperative estimation of component position
Time frame: direct postoperative and 12 months postoperatively
overall image quality
Time frame: pre- operatively and 12 months postoperatively
image diagnostic confidence
Time frame: pre- operatively and 12 months postoperatively
metal artifacts on images
Time frame: pre- operatively and 12 months postoperatively
Incontinence Severity Index (ISI)
Time frame: pre-operatively and 6 weeks and 12 months postoperatively
Urinary Distress Inventory, Short Form (UDI-6)
Time frame: pre-operatively and 6 weeks and 12 months postoperatively
Patient Global Impression of Severity (PGIS)
Time frame: pre-operatively and 6 weeks and 12 months postoperatively
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: pre-operatively and 6 weeks and 12 months postoperatively
Incontinence after Total Hip Arthroplasty
Time frame: 6 weeks and 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harmen B. Ettema, MD/PhD principal investigator
Isala
3 sites in 1 country: see every site and its status.
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.