RecruitingNot ApplicableNCT06342843

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

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


Sponsor

Isala

Enrollment

211 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURETotal Hip Arthroplasty

a surgical procedure in which an orthopaedic surgeon removes the damaged bone and cartilage and replaces this with prosthetic components.


Locations(3)

Amphia

Breda, North Brabant, Netherlands

Isala

Zwolle, Overijssel, Netherlands

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06342843


Related Trials