Health TrialsbyHealthPanel

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

ConditionOsteoarthritis, Hip
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIsala

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Total Hip Arthroplasty

    Procedure/Surgery

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

Treatment groups

211 Participants
are divided into 2 treatment groups
Group A: Posterolateral approach (PLA)Active comparator 1 intervention
Group B: Direct superior approach (DSA)Active comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Numeric Rating Scale (NRS)

Pain scoring on a 10-point Likert scale: 0 no pain to 10 worst thinkable pain

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

Short Form-12 (SF-12)

general health status, scored on 101-point Likert scale, 0 being worst health to 100 being ideal health

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

Hip disability and Osteoarthritis Outcome Score (HOOS)

evaluates symptoms and shortcomings in patients with hip complaints 5-point Likert scale, in which a higher score means less symptoms

Time frame
pre-operatively and 2 weeks, 6 weeks and 12 months postoperatively
4

Euro Quality of Life (EQ-5D)

measures health-related quality of life using 5 domains, questions scored on a 0-100 scale, the higher the score the better the quality of life

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Isala

Lead sponsor

Source ClinicalTrials.gov
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