Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg
About this trial
During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.
The surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for THA by Dr. Frans-Jozef Vandeputte or Professor Dr. Kristoff Corten
Provide signed and dated informed consent
Males or females age > 18 years
Disqualifiers
Neurological problems with sensorial and/or motoric disturbances (Multiple Sclerosis, Parkinson's disease, hemiplegia, …)
Previous surgery of the ipsilateral hip
Ipsilateral neck of femur fracture
Previous contralateral THA
Trial design
Design model
Parallel
Treatments tested in this trial
Vessel sparing technique
Procedure/SurgeryVessel sparing
Vessel ligation technique
Procedure/SurgeryVessel ligation
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Sacrificing vesselsActive comparator 1 intervention
Group B: Sparing vesselsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
a) Incidence of TFL tendinopathy
Clinical examination to detect TFL tendinopathy
Time frame
one year follow-up2
b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)
modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44
Time frame
one year follow-up3
b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)
Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100
Time frame
one year follow-up4
b-3) Patient-reported outcome 3: Forgotten Joint Score
Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100
Time frame
one year follow-upSecondary outcomes
1
Vessel sparing succesfull
Successful Yes/No
Time frame
end of surgerySponsors and contacts
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Source ClinicalTrials.gov