- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360210
Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA) (TFL)
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arthur SEGUINEAU, MD
- Email: arthur.seguineau@gbna-sante.fr
Study Contact Backup
- Name: Julie BELLARD
- Email: julie.bellard@chu-bordeaux.fr
Study Locations
-
-
-
Bordeaux, France, 33000
- Chu Bordeaux
-
Contact:
- Julie BELLARD
- Email: julie.bellard@chu-bordeaux.fr
-
Contact:
- Thierry FABRE, PROF
- Email: thierry.fabre@chu-bordeaux.fr
-
Principal Investigator:
- Thierry FABRE, PROF
-
Bordeaux, France, 33000
- Polyclinique Bordeaux Nord Aquitaine
-
Contact:
- Arthur SEGUINEAU, MD
- Email: arthur.seguineau@gbna-sante.fr
-
Principal Investigator:
- Arthur SEGUINEAU, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adult (>18 years old),
- patient undergoing primary Total Hip Arthroplasty through Direct Anterior Approach for osteoarthritis
Exclusion Criteria:
- hip dysplasia
- leg length discrepancy greater than 2cm
- history of homolateral hip surgery
- neuromuscular pathology
- patients declining the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Usual surgical procedure
Patient with usual surgical procedure : Total Hip Arthroplasty through Direct Anterior Approach
|
Data collection and self-administered questionnaire (HHS and SF-36)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between post operative functional results and TFL muscle damage
Time Frame: week 6
|
Correlation between :
|
week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Harris Hip score 6 months
Time Frame: 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 ,
|
6 months
|
|
Quality of life scale
Time Frame: 6 weeks, 6 months
|
Evolution of SF-36 questionnaire score between 6 weeks and 6 months after total hip arthroplasty
|
6 weeks, 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2024/83
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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