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

NCT06308965 | Recruiting

• 1 other identifier: Z-2023088
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Tensor Fasciae Latae Syndrome; Arthroplasty Complications

Keywords

Total Hip Arthroplasty; Ultra Sparing Procedure; Direct Anterior Approach

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (1)

• Vessel sparing succesfull

  end of surgery

Study Arms (2)

Sacrificing vessels

ACTIVE COMPARATOR

Procedure: Vessel ligation technique

Sparing vessels

EXPERIMENTAL

Procedure: Vessel sparing technique

Interventions

Vessel sparing technique PROCEDURE

Vessel sparing

Sparing vessels

Vessel ligation technique PROCEDURE

Vessel ligation

Sacrificing vessels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Central Study Contacts

Frans-Jozef Vandeputte, MD

CONTACT

+32 89 32 61 29; Frans-Jozef.Vandeputte@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 13, 2024
• Study Start: June 11, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)