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Recruiting NCT06308965

Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?

No phase Interventional Tensor Fasciae Latae Syndrome Arthroplasty Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vessel sparing technique, Vessel ligation technique.
Who it may be relevant to
Registry conditions: Tensor Fasciae Latae Syndrome, Arthroplasty Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

Primary objective: to compare a group with successful vessel-sparing with a vessel-sacrificed-group for:

1. Incidence of TFL tendinopathy 2. Patient-reported outcomes 3. Component placement Secondary objective: to observe the feasibility of the vessel-sparing surgical technique.

This is a monocentric prospective randomized blinded clinical trial during a period of minimum 3 years or until 150% of the sample size is included (100 patients).

Interventions

  • Procedure Vessel sparing technique
    Vessel sparing
  • Procedure Vessel ligation technique
    Vessel ligation

Primary outcome measures

  • a) Incidence of TFL tendinopathy [Time frame: one year follow-up]
  • b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) [Time frame: one year follow-up]
  • b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) [Time frame: one year follow-up]
  • b-3) Patient-reported outcome 3: Forgotten Joint Score [Time frame: one year follow-up]
  • b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). [Time frame: one year follow-up]
  • c) Component placement (x-rays) [Time frame: one year follow-up]
Secondary outcome measures (1)
  • Vessel sparing succesfull [Time frame: end of surgery]

Eligibility criteria

Inclusion criteria To be eligible to participate in this study, a subject must meet all criteria below;

  • 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

Exclusion criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

  • 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
  • Significant hip deformity: Crowe type 3 and 4 dysplasia, Leg-Calvé-Perthes
  • Avascular necrosis of the femoral head
  • Participating in another study that may interfere with participation in this study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Ziekenhuis Oost-Limburg — Genk

Identifiers

NCT: NCT06308965 · Z-2023088

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗