NCT06308965 Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
| NCT ID | NCT06308965 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ziekenhuis Oost-Limburg |
| Condition | Tensor Fasciae Latae Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-06-11 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-06-11 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06308965 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tensor Fasciae Latae Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308965 currently recruiting?
Yes, NCT06308965 is actively recruiting participants. Contact the research team at Frans-Jozef.Vandeputte@zol.be for enrollment information.
Where is the NCT06308965 trial being conducted?
This trial is being conducted at Genk, Belgium.
Who is sponsoring the NCT06308965 clinical trial?
NCT06308965 is sponsored by Ziekenhuis Oost-Limburg. The trial plans to enroll 300 participants.