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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.
Primary objective: to compare a group with successful vessel-sparing with a vessel-sacrificed-group for:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacrificing vessels | Active Comparator |
| |
| Sparing vessels | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vessel sparing technique | Procedure | Vessel sparing |
| |
| Measure | Description | Time Frame |
|---|---|---|
| a) Incidence of TFL tendinopathy | Clinical examination to detect TFL tendinopathy | one year follow-up |
| b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) | modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44 | one year follow-up |
| b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) | Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100 | one year follow-up |
| b-3) Patient-reported outcome 3: Forgotten Joint Score | Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100 | one year follow-up |
| b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). | Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100 | one year follow-up |
| c) Component placement (x-rays) | Using pelvic anteroposterior radiographs, with both legs internally rotated 15°: Acetabular version (Lewinnek method). Acetabular inclination Femoral alignment Under-sizing in case the femoral component is not touching cortical bone. | one year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Vessel sparing succesfull | Successful Yes/No | end of surgery |
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Inclusion criteria To be eligible to participate in this study, a subject must meet all criteria below;
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frans-Jozef Vandeputte, MD | Contact | +32 89 32 61 29 | Frans-Jozef.Vandeputte@zol.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Recruiting | Genk | Limburg | 3600 | Belgium |
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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).
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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.
| Vessel ligation technique |
| Procedure |
Vessel ligation |
|