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Not yet recruiting NCT07360210

Muscle Damage of the TFL (Tensor Fascia Latae) During Total Hip Arthroplasty (THA) Through Direct Anterior Approach (DAA)

No phase Interventional Hip Joint Surgery Arthroplasty Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection and self-administered questionnaire.
Who it may be relevant to
Registry conditions: Hip Joint, Surgery, Arthroplasty, Replacement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Other Data collection and self-administered questionnaire
    Data collection and self-administered questionnaire (HHS and SF-36)

Primary outcome measures

  • Correlation between post operative functional results and TFL muscle damage [Time frame: week 6]
Secondary outcome measures (2)
  • Harris Hip score 6 months [Time frame: 6 months]
  • Quality of life scale [Time frame: 6 weeks, 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • CHU Bordeaux — Bordeaux
  • Polyclinique Bordeaux Nord Aquitaine — Bordeaux

Identifiers

NCT: NCT07360210 · CHUBX 2024/83

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗