Tensor Fasciae Latae SyndromeUSPNCT06308965
Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
A study testing Vessel sparing technique and Vessel ligation technique in people with Tensor Fasciae Latae Syndrome and Arthroplasty Complications, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tensor Fasciae Latae Syndrome, Arthroplasty Complications
- What is being tested?
- Vessel sparing technique and Vessel ligation technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jun 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Frans-Jozef Vandeputte, MD, +32 89 32 61 29, Frans-Jozef.Vandeputte@zol.be
About this study
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.
Read the detailed description
Primary objective: to compare a group with successful vessel-sparing with a vessel-sacrificed-group for:
- Incidence of TFL tendinopathy
- Patient-reported outcomes
- 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).
- Being tested
- Vessel sparing technique, Vessel ligation technique
- Keywords
- Total Hip Arthroplasty, Ultra Sparing Procedure, Direct Anterior Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel sparing techniqueProcedure or surgery
Vessel sparing
Vessel ligation techniqueProcedure or surgery
Vessel ligation
| Study group | Role | What they receive |
|---|---|---|
| Sacrificing vessels | Active comparator | Not described Receives: Procedure: Vessel ligation technique |
| Sparing vessels | Experimental | Not described Receives: Procedure: Vessel sparing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
a) Incidence of TFL tendinopathy
Clinical examination to detect TFL tendinopathy
Measured: 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
Measured: 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
Measured: one year follow-up
b-3) Patient-reported outcome 3: Forgotten Joint Score
Forgotten Joint Score minimum (worse) score = 0 maximum (best) score = 100
Measured: 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
Measured: 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.
Measured: one year follow-up
Secondary outcomes (1)
Vessel sparing succesfull
Successful Yes/No
Measured: end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start11 Jun 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tensor Fasciae Latae SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308965
- Sponsor's protocol ID
- Z-2023088
- Acronym
- USP
- Status last verified
- Nov 2024
- First submitted
- 21 Feb 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?
- ClinicalTrials.gov ID
- NCT06308965
- Acronym / sponsor ID
- USP / Z-2023088
- Keywords
- Total Hip Arthroplasty, Ultra Sparing Procedure, Direct Anterior Approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Incidence of TFL tendinopathy
- Patient-reported outcomes
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Sacrificing vessels | Active comparator | Procedure: Vessel ligation technique |
| Sparing vessels | Experimental | Procedure: Vessel sparing technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vessel sparing techniqueVessel sparing | Procedure or surgery | Sparing vessels |
| Vessel ligation techniqueVessel ligation | Procedure or surgery | Sacrificing vessels |
Primary outcome
a) Incidence of TFL tendinopathy
Time frame: one year follow-up
Clinical examination to detect TFL tendinopathy
b-1) Patient-reported outcome 1: modified Harris Hip Score (HHS)
Time frame: one year follow-up
modified Harris Hip Score (HHS) minimum (worse) score = 0 maximum (best) score = 44
b-2) Patient-reported outcome 2: Hip And Groin Outcome Score (HAGOS)
Time frame: one year follow-up
Hip And Groin Outcome Score (HAGOS) minimum (worse) score = 0 maximum (best) score = 100
b-3) Patient-reported outcome 3: Forgotten Joint Score
Time frame: 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).
Time frame: one year follow-up
Hip disability and Osteoarthritis Outcome Score (HOOS) minimum (worse) score = 0 maximum (best) score = 100
c) Component placement (x-rays)
Time frame: 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.
1 secondary outcome
Vessel sparing succesfull
Time frame: end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vessel sparing technique and Vessel ligation technique in people with Tensor Fasciae Latae Syndrome and Arthroplasty Complications, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frans-Jozef Vandeputte, MD (+32 89 32 61 29, Frans-Jozef.Vandeputte@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a) Incidence of TFL tendinopathy (time frame: one year follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.