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

Arthroplasty Complications Clinical Trial

— USP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06308965
• Other study ID #: Z-2023088
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: Ziekenhuis Oost-Limburg
• Contact: Sarah Maes
• Phone: +32 89 21 20 21
• Email: CTU[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications

Intervention

Procedure:
• Vessel technique
Vessel sparing vs Vessel ligation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a) Incidence of TFL tendinopathy	Clinical examination to detect TFL tendinopathy	one year follow-up
Primary	b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)	modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44	one year follow-up
Primary	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	one year follow-up
Primary	b-3) Patient-reported outcome 3: Forgotten Joint Score	Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100	one year follow-up
Primary	b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS).	Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100	one year follow-up
Primary	c) Component placement (x-rays)	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.	one year follow-up
Secondary	Vessel sparing succesfull	Successful Yes/No	end of surgery