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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty Complications; Tensor Fasciae Latae Syndrome
• Intervention / Treatment: Procedure: Vessel ligation technique; Procedure: Vessel sparing technique

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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Frans-Jozef Vandeputte, MD; Phone Number: +32 89 32 61 29; Email: Frans-Jozef.Vandeputte@zol.be

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Frans-Jozef Vandeputte, MD; Phone Number: +32 89 32 61 29; Email: Frans-Jozef.Vandeputte@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sacrificing vessels	Procedure: Vessel ligation technique; Vessel ligation
Experimental: Sparing vessels	Procedure: Vessel sparing technique; Vessel sparing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a) Incidence of TFL tendinopathy	Clinical examination to detect TFL tendinopathy	one year follow-up
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
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
b-3) Patient-reported outcome 3: Forgotten Joint Score	Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100	one year follow-up
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vessel sparing succesfull	Successful Yes/No	end of surgery

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 12, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Total Hip Arthroplasty; Direct Anterior Approach; Ultra Sparing Procedure
• Other Study ID Numbers: Z-2023088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No