Clinical trial NCT06342843: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty (SPLAsH)
Official title: Direct Superior Approach Versus PosteroLateral Approach in Total Hip Arthroplasty: a Multicenter Double Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, prospective, double blinded, randomized controlled intervention study
Primary purpose: TREATMENT

Brief 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.

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form
timeFrame: pre-operatively and 2 weeks postoperatively
Secondary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Short Form-12 (SF-12)
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Hip disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Euro Quality of Life (EQ-5D)
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Global Rating of Change scale
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Timed Up and Go test (TUG test)
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: 40 meter self-paced walk test for hip osteoarthritis
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Stair climb test
timeFrame: pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
measure: Step count application on iPhone
timeFrame: first to 2 weeks postoperatively
measure: Muscle atrophy by using Computer Tomography (CT) scanner
timeFrame: pre-operatively and 12 months postoperatively
measure: Computer Tomography (CT) image with orthopedic metal artefact reduction (O-MAR)
timeFrame: pre-operatively and 12 months postoperatively
measure: Postoperative cup position on Computer Tomography (CT) image
timeFrame: 12 months postoperatively
measure: Comparing definite cup position with preoperative planned cup position
timeFrame: pre- operatively and 12 months postoperatively
measure: Comparing definite component position with surgeon's perioperative estimation of component position
timeFrame: direct postoperative and 12 months postoperatively
measure: overall image quality
timeFrame: pre- operatively and 12 months postoperatively
measure: image diagnostic confidence
timeFrame: pre- operatively and 12 months postoperatively
measure: metal artifacts on images
timeFrame: pre- operatively and 12 months postoperatively
measure: Incontinence Severity Index (ISI)
timeFrame: pre-operatively and 6 weeks and 12 months postoperatively
measure: Urinary Distress Inventory, Short Form (UDI-6)
timeFrame: pre-operatively and 6 weeks and 12 months postoperatively
measure: Patient Global Impression of Severity (PGIS)
timeFrame: pre-operatively and 6 weeks and 12 months postoperatively
measure: Incontinence Impact Questionnaire Short Form (IIQ-7)
timeFrame: pre-operatively and 6 weeks and 12 months postoperatively
measure: Incontinence after Total Hip Arthroplasty
timeFrame: 6 weeks and 12 months postoperatively
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia
state: Brabant
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
city: Zwolle
country: Netherlands
facility: Isala
state: Overijssel
Study officials:
affiliation: Isala
name: Harmen B. Ettema, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: