An observational study in Total Hip Arthroplasty, sponsored by Assistance Publique - Hôpitaux de Paris. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
30 studies on the registry are indexed under Leg Length Inequality; 2 are open to participants now.
This study's enrollment of 185 is above the median of 90 across 11 observational studies indexed under Leg Length Inequality.
Browse Leg Length Inequality studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in anatomic lower limb length measurements between preoperative and postoperative measurements
Time frame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements
Time frame: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
HOOS score (Hip disability and osteoarthritis outcome score)
The outcome score consists of 40 items assessing 5 subscales. Pain (P) includes 10 items with a total score of 40 points, Symptoms (S) includes 5 items with a total score of 20, Activity limitations daily living (ADL) includes 17 items with a total score of 68 and finally Function in sport and recreation (SP) and hip related quality of life both include 4 items with a total score of 16 each. To answer the questions, standardized answer options are given with scores from 0 to 4 (no, mild, moderate, severe and extreme). To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. To calculate the total HOOS score the subscales need to be summed up, using following formula for all dimension. 100 - \[(patient's score of the subscale x 100)/(total score of the subscale)\]
Time frame: 24 months after surgery
No study locations are listed for this record.
Ran from Jan 2015 to primary completion in May 2017, 28 months.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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