Clinical trial NCT03437343: Leg Length and Quality of Life After Total Hip Arthroplasty
Official title: Evaluation of Surgeon Performance to Restore Leg Length and Evaluation of the Quality of Life After Total Hip Replacement Related to the Reconstructed Anatomy With EOS Imaging System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Arthroplasty
Keywords: EOS
total hip arthroplasty
performance of surgeons
leg length discrepancy
HOOS
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Région Ile de France, France
First posted: 2018-02-19
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

Brief summary: This study used 3D reconstructions from the EOS biplanar radiographic imaging system to perform leg length measurements before and after THA (Total hip arthroplasty) on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA and the relationships between the quality of life, estimated by the HOOS score (Hip disability and osteoarthritis outcome score), and the anatomy of the new hip in standing position.

Detailed description: The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.

This retrospective study used 3D reconstructions from the EOS biplanar radiographic imaging system (EOS imaging, Paris, France) to perform leg length measurements before and after THA on all included THA patients from 2015 to evaluate surgeon performance in restoring lower limb length after THA. Included patients either had hip osteoarthritis or femoral head osteonecrosis. Patients were excluded if they were undergoing revision surgery, or had a contralateral THA or total knee.

The performance of the surgeons was judged using the Cumulative Sum control chart (CUSUM) method.

Our objective was to study surgeon performance, measured by their ability to restore the initial preoperative length of the operated leg or to equalize the length of the two legs, and evaluate the relationships between the quality of life, estimated by the HOOS score, and the anatomy of the new hip in standing position using the EOS imaging system.

Eligibility criteria: Inclusion Criteria:

* unilateral total hip replacement for osteoarthritis or avascular necrosis healthy contralateral hip
* age over 18 years
* informed consent to participate in the study
* radiographs obtained after total hip replacement using the EOS imaging system, filled HOOS form
* clinical follow-up of 12 months at least

Exclusion Criteria:

* past history of contralateral hip replacement
* ipsi or contralateral knee replacement
* hip arthroplasty performed using a Kerboull cross
* post-operative complications such as infection

Primary outcomes:
measure: Change in anatomic lower limb length measurements between preoperative and postoperative measurements
timeFrame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
Secondary outcomes:
measure: Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements
timeFrame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
measure: HOOS score (Hip disability and osteoarthritis outcome score)
timeFrame: 24 months after surgery
Other outcomes:
Locations:
Study officials:
References: