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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-11

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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

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Tensor Fasciae Latae Syndrome Arthroplasty Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a monocentric prospective randomized blinded clinical trial during a period of minimal 3 years or until 150% of sample size is included (100 patients).

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Participants will be blinded and randomized into two cohorts. The selection and randomization protocol is as follows: participants eligible for the study are requested to participate and informed by the study nurse. If the patient agreed to participate, informed consent is obtained, and the patient is included in the study. At that time, the study nurse uses a mobile randomization application (Random, Dublin, Ireland) to allocate them either to the 'standard' (sacrificing the vessels) or 'vessel sparing' DAA.

Weighted randomization (1:2) is applied to compensate for a dropout of patients planned for vessel sparing surgery, but in whom the vessels were damaged unintendedly. In case a bilateral procedure will be performed, each side is randomized individually.

Surgery will be performed by the surgeon. Data collection before and after surgery is collected by personal assistant who is unaware of group assignment.

Study Groups

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Sacrificing vessels

Group Type ACTIVE_COMPARATOR

Vessel ligation technique

Intervention Type PROCEDURE

Vessel ligation

Sparing vessels

Group Type EXPERIMENTAL

Vessel sparing technique

Intervention Type PROCEDURE

Vessel sparing

Interventions

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Vessel sparing technique

Vessel sparing

Intervention Type PROCEDURE

Vessel ligation technique

Vessel ligation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No