Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06308965

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

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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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