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

Isala

Status: Enrolling

Conditions: Osteoarthritis, Hip

Treatments: Procedure: Total Hip Arthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06342843

NL81395.075.22 (Other Identifier)

SPLAsH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 211 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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211 participants in 2 patient groups

Posterolateral approach (PLA)

Active Comparator group

Description:

THA by using the posterolateral approach

Treatment:

Procedure: Total Hip Arthroplasty

Direct superior approach (DSA)

Active Comparator group

Description:

THA using the direct superior approach

Treatment:

Procedure: Total Hip Arthroplasty