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

NCT06342843 | Recruiting

• 2 other identifiers: SPLAsHNL81395.075.22
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 3

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.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• 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, 6 weeks, 3months and 12 months postoperatively

Secondary Outcomes (21)

• Numeric Rating Scale (NRS)

  pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

• Short Form-12 (SF-12)

  pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

• Hip disability and Osteoarthritis Outcome Score (HOOS)

  pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively

• Euro Quality of Life (EQ-5D)

  pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

• Global Rating of Change scale

  pre-operatively and 2 weeks, 6 weeks, 3 months and 12 months postoperatively

Study Arms (2)

Posterolateral approach (PLA)

ACTIVE COMPARATOR

THA by using the posterolateral approach

Procedure: Total Hip Arthroplasty

Direct superior approach (DSA)

ACTIVE COMPARATOR

THA using the direct superior approach

Procedure: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty PROCEDURE

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

Direct superior approach (DSA); Posterolateral approach (PLA)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Sites (3)

Amphia

Breda, North Brabant, 4818CK, Netherlands

RECRUITING

Isala

Zwolle, Overijssel, 8000 GK, Netherlands

RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Harmen B. Ettema, MD/PhD

  Isala

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harmen Ettema, MD/PhD

CONTACT

0031886245656; h.b.ettema@isala.nl

Roelina Munnik-Hagewoud, PhD

CONTACT

0031886245375; r.munnik@isala.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: multicenter, prospective, double blinded, randomized controlled intervention study

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: April 2, 2024
• Study Start: March 26, 2024
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)