Actively Recruiting
Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
Led by Ziekenhuis Oost-Limburg · Updated on 2024-11-15
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a blood vessel-sparing surgical technique during direct anterior approach total hip arthroplasty (DAA THA) can improve clinical outcomes compared to the standard vessel ligation method. This trial focuses on patients undergoing hip replacement and aims to determine if sparing the lateral femoral circumflex artery reduces muscle tenderness and the incidence of tensor fascia lata (TFL) tendinopathy. The study is a prospective, randomized, blinded clinical trial conducted at a single center, with a planned duration of at least three years or until enrollment exceeds the target sample size by 50% (100 patients). Participants will be randomly assigned to one of two groups: one undergoing the vessel-sparing surgical procedure and the other receiving the standard vessel ligation technique. The feasibility of the vessel-sparing technique, including whether it can be successfully performed in about 60% of patients, will be observed. The trial will compare clinical outcomes such as the incidence of TFL tendinopathy, patient-reported hip function scores, and component placement on X-rays one year after surgery. During the study, patients will be monitored through follow-up assessments at one year post-surgery, including evaluations of TFL tendinopathy incidence, modified Harris Hip Score, Hip And Groin Outcome Score, Forgotten Joint Score, and Hip disability and Osteoarthritis Outcome Score. X-ray imaging will assess the placement of hip components. The success of the vessel-sparing technique will be assessed at the end of surgery. The entire participant involvement is designed to collect comprehensive data on surgical outcomes and patient-reported measures to understand the impact of the vessel-sparing approach.
CONDITIONS
Brief Title
Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for total hip arthroplasty by Dr. Frans-Jozef Vandeputte or Professor Dr. Kristoff Corten
- Provide signed and dated informed consent
- Male or female aged over 18 years
You will not qualify if you...
- Neurological problems with sensory or motor disturbances (e.g., Multiple Sclerosis, Parkinson's disease, hemiplegia)
- Previous surgery on the same side hip
- Fracture of the neck of femur on the same side hip
- Previous total hip arthroplasty on the opposite side
- Significant hip deformity such as Crowe type 3 and 4 dysplasia or Leg-Calvé-Perthes disease
- Avascular necrosis of the femoral head
- Participation in another study that may interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus hospital recovery period
Participants undergo total hip arthroplasty using either the vessel-sparing or vessel-ligation surgical technique and receive immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 1 year
Participants are followed for clinical outcomes, including tendinopathy incidence, patient-reported outcomes, and component placement assessment.
Regular follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
Research Team
F
Frans-Jozef Vandeputte, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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