Hip JointTFLNCT07360210
Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA)
A study testing Data collection and self-administered questionnaire in people with Hip Joint and Surgery, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
Direct Anterior Approach (DAA) is known to cause damage to the TFL during the surgical approach, the point of this study is to evaluate the impact between the severity of the per operative TFL damage and the functional short term results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Joint, Surgery, Arthroplasty
- What is being tested?
- Data collection and self-administered questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2026to Oct 2026
- 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
- adult (>18 years old),
- patient undergoing primary Total Hip Arthroplasty through Direct Anterior Approach for osteoarthritis
Who cannot join
- hip dysplasia
- leg length discrepancy greater than 2cm
- history of homolateral hip surgery
- neuromuscular pathology
- patients declining the protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Arthur SEGUINEAU, MD contact
Julie BELLARD contact
France2 sites
CHU Bordeaux
Bordeaux, 33000
Thierry FABRE, PROF, thierry.fabre@chu-bordeaux.fr
Julie BELLARD, julie.bellard@chu-bordeaux.fr
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000
Arthur SEGUINEAU, MD, arthur.seguineau@gbna-sante.fr
Arthur SEGUINEAU, MD
About this study
Official title: Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA), Evaluation of the Correlation With Short Term Functional Results
Direct Anterior Approach (DAA) is known to cause damage to the TFL during the surgical approach, the point of this study is to evaluate the impact between the severity of the per operative TFL damage and the functional short term results.
Read the detailed description
Total hip arthroplasty is one of the most frequent surgical procedure and it has changed the approach of hip arthrosis. There are a few surgical approaches frequently used : posterolateral approach, anterolateral approach and the direct anterior approach. It has been previously shown that the DAA is causing less muscle damage than the other surgical approaches, the anterior interval is considered as internervous and intermuscular muscle-sparing technique. However, several reports have proved that the DAA was also associated with muscle damage, particularly to the tensor fascia lata during the exposition with the instruments.
The purpose of this study is to determinate the correlation between the severity of muscle damage during surgery and the functional post operative short and medium term results. We underwent grading visible muscle damage during surgery after implant positioning by a grading system in 5 stages from 0 (intact or a few fibers) to 4 (more than 75% of muscle damage). Functional results were established by Harris Hip Score at 6 weeks and 6 months follow up.
- Conditions
- Hip Joint, Surgery, Arthroplasty, Replacement, Surgical Wound, Muscle Injury
- Being tested
- Data collection and self-administered questionnaire
- Keywords
- TFL damage, Total Hip Arthroplasty through Direct Anterior Approach
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection and self-administered questionnaireOther
Data collection and self-administered questionnaire (HHS and SF-36)
| Study group | Role | What they receive |
|---|---|---|
| Usual surgical procedure | Other | Patient with usual surgical procedure : Total Hip Arthroplasty through Direct Anterior Approach Receives: Other: Data collection and self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between post operative functional results and TFL muscle damage
Correlation between :
- short term post operative functional results, evaluated by Harris Hip score at 6 weeks. Harris Hip score has 10 items with several propositions per each item and total score from 2 to 100 , and
- TFL muscle damage grade during surgery evaluated with ATHLAS classification : score 0 (intact or few fibres), 1 (0-25% of fibres), 2 (25-50%), 3 (50-75%) et 4 (>75%)
Measured: week 6
Secondary outcomes (2)
Harris Hip score 6 months
Result of Harris Hip score at 6 months Harris Hip score has 10 items with several propositions per each item and total score from 2 to 100 ,
Measured: 6 months
Quality of life scale
Evolution of SF-36 questionnaire score between 6 weeks and 6 months after total hip arthroplasty
Measured: 6 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip JointStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360210
- Sponsor's protocol ID
- CHUBX 2024/83
- Acronym
- TFL
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA), Evaluation of the Correlation With Short Term Functional Results
- ClinicalTrials.gov ID
- NCT07360210
- Acronym / sponsor ID
- TFL / CHUBX 2024/83
- Conditions
- Hip Joint, Surgery, Arthroplasty, Replacement, Surgical Wound, Muscle Injury
- Keywords
- TFL damage, Total Hip Arthroplasty through Direct Anterior Approach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Jan 2026 (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.
Direct Anterior Approach (DAA) is known to cause damage to the TFL during the surgical approach, the point of this study is to evaluate the impact between the severity of the per operative TFL damage and the functional short term results.
Detailed description
Total hip arthroplasty is one of the most frequent surgical procedure and it has changed the approach of hip arthrosis. There are a few surgical approaches frequently used : posterolateral approach, anterolateral approach and the direct anterior approach. It has been previously shown that the DAA is causing less muscle damage than the other surgical approaches, the anterior interval is considered as internervous and intermuscular muscle-sparing technique. However, several reports have proved that the DAA was also associated with muscle damage, particularly to the tensor fascia lata during the exposition with the instruments.
The purpose of this study is to determinate the correlation between the severity of muscle damage during surgery and the functional post operative short and medium term results. We underwent grading visible muscle damage during surgery after implant positioning by a grading system in 5 stages from 0 (intact or a few fibers) to 4 (more than 75% of muscle damage). Functional results were established by Harris Hip Score at 6 weeks and 6 months follow up.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usual surgical procedure | Other | Other: Data collection and self-administered questionnairePatient with usual surgical procedure : Total Hip Arthroplasty through Direct Anterior Approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult (>18 years old),
- patient undergoing primary Total Hip Arthroplasty through Direct Anterior Approach for osteoarthritis
Key exclusion criteria (5 listed)
- hip dysplasia
- leg length discrepancy greater than 2cm
- history of homolateral hip surgery
- neuromuscular pathology
- patients declining the protocol
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 |
|---|---|---|
| Data collection and self-administered questionnaireData collection and self-administered questionnaire (HHS and SF-36) | Other | Usual surgical procedure |
Primary outcome
Correlation between post operative functional results and TFL muscle damage
Time frame: week 6
Correlation between : * short term post operative functional results, evaluated by Harris Hip score at 6 weeks. Harris Hip score has 10 items with several propositions per each item and total score from 2 to 100 , and * TFL muscle damage grade during surgery evaluated with ATHLAS classification : score 0 (intact or few fibres), 1 (0-25% of fibres), 2 (25-50%), 3 (50-75%) et 4 (>75%)
2 secondary outcomes
Harris Hip score 6 months
Time frame: 6 months
Quality of life scale
Time frame: 6 weeks, 6 months
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 22 Jan 2026.
Related trials for Hip Joint
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
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.
Arthur SEGUINEAU, MD contact
Julie BELLARD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data collection and self-administered questionnaire in people with Hip Joint and Surgery, run by University Hospital, Bordeaux at 2 sites in France.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Arthur SEGUINEAU, MD (arthur.seguineau@gbna-sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between post operative functional results and TFL muscle damage (time frame: week 6). 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 22 Jan 2026.