Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06342843
Other study ID # SPLAsH
Secondary ID NL81395.075.22
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05773261 - Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups N/A
Recruiting NCT05223777 - KINCISE™ Surgical Automated System in Total Hip Arthroplasty (THA) N/A
Recruiting NCT04731077 - Avenir Complete Post-Market Clinical Follow-Up Study N/A
Not yet recruiting NCT04448106 - Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) for Osteoarthritis Phase 2
Completed NCT05070871 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women N/A
Not yet recruiting NCT06162195 - The ACTIVE Trial: A Prospective Randomised Control Trial Of The H1 Implant Versus Total Hip Replacement N/A
Withdrawn NCT02743208 - Evaluation of a Short Femoral Stem in Total Hip Arthroplasty N/A
Completed NCT02944448 - A Study Evaluating Pain Relief and Safety of Orally Administered CR845 in Patients With Osteoarthritis of Hip or Knee Phase 2
Active, not recruiting NCT02229279 - Evaluation of Teleconsulting on Rehabilitation After Hip and Knee Surgical Procedures N/A
Active, not recruiting NCT02851992 - A Prospective Study to Evaluate Long-term Clinical Outcomes of the GTS Cementless Femoral Stem N/A
Completed NCT01700933 - Dose-response: Exercise Therapy on Hip Osteoarthritis N/A
Completed NCT01618708 - A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip N/A
Completed NCT01214954 - Early Rehabilitation After Total Hip Replacement N/A
Active, not recruiting NCT00294424 - Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements N/A
Terminated NCT00588861 - Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement N/A
Withdrawn NCT05054595 - Audio-Recorded vs. Nurse-Led Brief Mindfulness-Based Intervention N/A
Terminated NCT00973141 - A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis-related Pain Phase 2
Recruiting NCT05014113 - H-28 DELTA ST-C and Minima Retrospective Study.
Completed NCT01066936 - Mini Stem DEXA (Dual Energy X-ray Absorptiometry)
Recruiting NCT05530551 - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA N/A