Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID06342843

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

Led by Isala · Updated on 2025-08-03

211

Participants Needed

3

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two surgical methods for total hip arthroplasty (THA) in patients with disabling hip osteoarthritis: the posterolateral approach (PLA), considered the standard, and the direct superior approach (DSA). This study aims to assess differences in postoperative pain, health-related quality of life (HRQoL), physical function, rehabilitation, urinary incontinence, muscle atrophy, and implant positioning. A new CT imaging technique to reduce metal artifacts will also be evaluated. Participants will be randomly assigned to receive THA via either the PLA or DSA method. Both groups undergo surgery followed by assessments at multiple timepoints: before surgery, and at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months afterward. The study includes a double-blind design where neither patients nor researchers know the surgical method used until one year post-surgery. CT scans will be used to measure muscle atrophy, implant positioning, and to validate the new imaging technique. During the study, participants will complete various physical function tests and questionnaires assessing pain, quality of life, and urinary incontinence at scheduled visits. Muscle atrophy and implant placement will be examined with CT scans preoperatively and at 12 months postoperatively. Researchers will also monitor for complications such as infections or dislocations. The primary outcome focuses on physical function measured by the Hip Disability and Osteoarthritis Outcome Score-Physical Function Short Form (HOOS-PS) over one year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Has symptomatic incapacitating coxarthrosis confirmed by physical exam and pelvic/hip X-ray requiring total hip arthroplasty
  • Has signed informed consent
  • Is aged 18 years or older at study entry
  • Is competent and able to participate in follow-up
Not Eligible

You will not qualify if you...

  • Previous surgery on the same hip
  • Body mass index (BMI) over 35 kg/m2
  • Contralateral incapacitating coxarthrosis confirmed by physical exam and pelvic/hip X-ray
  • Neurological conditions affecting walking pattern
  • Unable to walk without aid before surgery
  • Rheumatoid arthritis
  • Severe hip dysplasia
  • Cognitive impairment
  • Malignancies or metastases involving the hip or nearby soft tissues
  • Unable to speak and write Dutch language

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of surgery and initial recovery period

Participants undergo total hip arthroplasty using either the direct superior approach or the posterolateral approach.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants attend follow-up visits to assess health-related quality of life, physical function, muscle atrophy, component placement, and urinary incontinence after surgery.

Visits at 2 weeks, 6 weeks, 3 months, and 12 months postoperatively (in-person)

Trial Site Locations

Total: 3 locations

1

Amphia

Breda, North Brabant, Netherlands, 4818CK

Actively Recruiting

2

Isala

Zwolle, Overijssel, Netherlands, 8000 GK

Actively Recruiting

3

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands, 8934AD

Actively Recruiting

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Research Team

H

Harmen Ettema, MD/PhD

R

Roelina Munnik-Hagewoud, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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