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NCT Number: NCT06308965

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

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.

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Key information

Conditions

Tensor Fasciae Latae Syndrome Arthroplasty Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location status: Recruiting

Location contact

Frans-Jozef Vandeputte, MD

CONTACT

[email protected]

+32 89 32 61 29

About this study

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

  • Incidence of TFL tendinopathy
  • Patient-reported outcomes
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vessel sparing technique

Procedure

Vessel sparing

Vessel ligation technique

Procedure

Vessel ligation

Primary outcomes

  1. a) Incidence of TFL tendinopathy

    Time frame: one year follow-up

    Clinical examination to detect TFL tendinopathy

  2. b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)

    Time frame: one year follow-up

    modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44

  3. b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)

    Time frame: one year follow-up

    Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100

  4. b-3) Patient-reported outcome 3: Forgotten Joint Score

    Time frame: one year follow-up

    Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100

  5. b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS).

    Time frame: one year follow-up

    Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100

  6. c) Component placement (x-rays)

    Time frame: one year follow-up

    Using pelvic anteroposterior radiographs, with both legs internally rotated 15°:

    Acetabular version (Lewinnek method). Acetabular inclination Femoral alignment Under-sizing in case the femoral component is not touching cortical bone.

Secondary outcomes

  1. Vessel sparing succesfull

    Time frame: end of surgery

    Successful Yes/No

Study contacts

Contact information is provided by the study sponsor or research team.

Frans-Jozef Vandeputte, MD

CONTACT

[email protected]

+32 89 32 61 29

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Acronym: USP

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Mar 13, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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