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

Not Applicable

Recruiting

• Conditions: Arthroplasty Complications; Tensor Fasciae Latae Syndrome

• Registration Number: NCT06308965
• Lead Sponsor: Ziekenhuis Oost-Limburg

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).

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-13
• Study Start: 2024-06-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
a) Incidence of TFL tendinopathy	one year follow-up	Clinical examination to detect TFL tendinopathy
b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS).	one year follow-up	Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100
b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)	one year follow-up	Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100
b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)	one year follow-up	modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44
b-3) Patient-reported outcome 3: Forgotten Joint Score	one year follow-up	Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100
c) Component placement (x-rays)	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 Outcome Measures

Name	Time	Method
Vessel sparing succesfull	end of surgery	Successful Yes/No

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Limburg, Belgium