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

Osteoarthritis, Hip Clinical Trial

— SPLAsH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342843
• Other study ID #: SPLAsH
• Secondary ID: NL81395.075.22
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: March 2024
• Source: Isala
• Contact: Harmen Ettema, MD/PhD
• Phone: 0031886245656
• Email: h.b.ettema[@]isala.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). In addition, the CT images will be used to validate a new metal artefact reduction technique.

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, Stair Climb Test and steps counting app). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 211
• Est. completion date: November 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• Total Hip Arthroplasty
a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.

Locations

Country	Name	City	State
Netherlands	Amphia	Breda	Brabant
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Friesland
Netherlands	Isala	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	pre-operatively and 2 weeks postoperatively
Secondary	Numeric Rating Scale (NRS)	Pain scoring on a 10-point Likert scale: 0 no pain to 10 worst thinkable pain	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	Short Form-12 (SF-12)	general health status, scored on 101-point Likert scale, 0 being worst health to 100 being ideal health	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	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	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	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	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	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)	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	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.	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	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	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	Stair climb test	measures the time an individual needs to ascend and descent a stair with 10 steps	pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
Secondary	Step count application on iPhone	individual's activity will be measured with a wearable, activity-monitoring sensor (iPhone Health application). Activity per day is monitored and expressed as total distance covered per day, the number of steps per day, and the number of stairs taken per day	first to 2 weeks postoperatively
Secondary	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.	pre-operatively and 12 months postoperatively
Secondary	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.	pre-operatively and 12 months postoperatively
Secondary	Postoperative cup position on Computer Tomography (CT) image	The initial abduction/inclination of the cup, angle a, 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 ß) 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.	12 months postoperatively
Secondary	Comparing definite cup position with preoperative planned cup position	The initial abduction/inclination of the cup, angle a, is measured with respect to ischial bone, which is used as internal reference. The anterior opening angle of cup (angle ß) 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	pre- operatively and 12 months postoperatively
Secondary	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 a, is measured with respect to ischial bone, which is used as internal reference. The anterior opening angle of the cup (angle ß) 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.	direct postoperative and 12 months postoperatively
Secondary	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).	pre- operatively and 12 months postoperatively
Secondary	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).	pre- operatively and 12 months postoperatively
Secondary	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.	pre- operatively and 12 months postoperatively
Secondary	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.	pre-operatively and 6 weeks and 12 months postoperatively
Secondary	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.	pre-operatively and 6 weeks and 12 months postoperatively
Secondary	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).	pre-operatively and 6 weeks and 12 months postoperatively
Secondary	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.	pre-operatively and 6 weeks and 12 months postoperatively
Secondary	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.	6 weeks and 12 months postoperatively