Vessel-sparing surgery for hip replacement
Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
NA · Ziekenhuis Oost-Limburg · NCT06308965
This study is testing a new hip replacement surgery that aims to save blood vessels to see if it helps patients recover better than the traditional method that cuts them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg (other) |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06308965 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility and outcomes of a vessel-sparing surgical technique during direct anterior approach total hip arthroplasty (THA). The study compares patients undergoing vessel-sparing surgery with those who have their vessels ligated, focusing on the incidence of tensor fascia lata (TFL) tendinopathy and patient-reported outcomes. It is a monocentric, prospective, randomized, and blinded trial aiming to enroll 100 patients over a minimum of three years. The hypothesis is that preserving blood vessels will lead to better clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for total hip arthroplasty by the specified surgeons.
Not a fit: Patients with neurological disorders, previous hip surgeries, or significant hip deformities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the incidence of TFL tendinopathy and improve recovery outcomes for patients undergoing hip replacement.
How similar studies have performed: While this approach is novel, similar studies have shown promising results in preserving blood vessels during surgical procedures.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (RECRUITING)
Study contacts
- Study coordinator: Frans-Jozef Vandeputte, MD
- Email: Frans-Jozef.Vandeputte@zol.be
- Phone: +32 89 32 61 29
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tensor Fasciae Latae Syndrome, Arthroplasty Complications, Total Hip Arthroplasty, Ultra Sparing Procedure, Direct Anterior Approach