- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437343
Leg Length and Quality of Life After Total Hip Arthroplasty (EOS-PTH)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
|
|
HOOS score (Hip disability and osteoarthritis outcome score)
Time Frame: 24 months after surgery
|
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)] |
24 months after surgery
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- NI17039J
- 2017-A03333-50 (Registry Identifier: ANSM)
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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