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

East Limburg Hospital

Status: Enrolling

Conditions: Arthroplasty Complications; Tensor Fasciae Latae Syndrome

Treatments: Procedure: Vessel ligation technique; Procedure: Vessel sparing technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06308965

Z-2023088

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups

Sacrificing vessels

Active Comparator group

Treatment:

Procedure: Vessel ligation technique

Sparing vessels

Experimental group

Treatment:

Procedure: Vessel sparing technique