Clinical trial NCT06308965: Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
Official title: Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tensor Fasciae Latae Syndrome
Arthroplasty Complications
Keywords: Total Hip Arthroplasty
Ultra Sparing Procedure
Direct Anterior Approach
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a monocentric prospective randomized blinded clinical trial during a period of minimal 3 years or until 150% of sample size is included (100 patients).
Primary purpose: TREATMENT

Brief summary: 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).

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

Primary outcomes:
measure: a) Incidence of TFL tendinopathy
timeFrame: one year follow-up
measure: b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)
timeFrame: one year follow-up
measure: b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)
timeFrame: one year follow-up
measure: b-3) Patient-reported outcome 3: Forgotten Joint Score
timeFrame: one year follow-up
measure: b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS).
timeFrame: one year follow-up
measure: c) Component placement (x-rays)
timeFrame: one year follow-up
Secondary outcomes:
measure: Vessel sparing succesfull
timeFrame: end of surgery
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
References: