NCT06308965

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ziekenhuis Oost-Limburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tensor Fasciae Latae Syndrome
• Arthroplasty Complications

Interventions

Type	Name	Description
PROCEDURE	Vessel sparing technique	Vessel sparing
PROCEDURE	Vessel ligation technique	Vessel ligation

Timeline

• Start date: 2024-06-11
• Primary completion: 2025-03-01
• Completion: 2027-03-01
• First posted: 2024-03-13
• Last updated: 2024-11-15

Locations

1 site across 1 country: Belgium