Arthroplasty Complications, Tensor Fasciae Latae Syndrome
Conditions
Keywords
Total Hip Arthroplasty, Ultra Sparing Procedure, Direct Anterior Approach
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.
Detailed description
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).
Interventions
PROCEDUREVessel ligation technique
Vessel ligation
PROCEDUREVessel sparing technique
Vessel sparing
Sponsors
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS) | one year follow-up | Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100 |
| a) Incidence of TFL tendinopathy | one year follow-up | Clinical examination to detect TFL tendinopathy |
| b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS) | one year follow-up | modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44 |
| c) Component placement (x-rays) | one year follow-up | 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. |
| b-3) Patient-reported outcome 3: Forgotten Joint Score | one year follow-up | Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100 |
| b-4) Patient-reported outcome 4: Hip disability and Osteoarthritis Outcome Score (HOOS). | one year follow-up | Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel sparing succesfull | end of surgery | Successful Yes/No |
Countries
Belgium
Contacts
Primary ContactFrans-Jozef Vandeputte, MD
Outcome results
None listed