Total Hip ArthroplastyEOS-PTHNCT03437343
Leg Length and Quality of Life After Total Hip Arthroplasty
An observational study of Total Hip Arthroplasty, run by Assistance Publique - Hôpitaux de Paris.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Hip arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.
Who may be able to join
- 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
Who cannot join
- past history of contralateral hip replacement
- ipsi or contralateral knee replacement
- hip arthroplasty performed using a Kerboull cross
- post-operative complications such as infection
About this study
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
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.
Read the 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.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Hip arthroplasty
- Keywords
- EOS, total hip arthroplasty, performance of surgeons, leg length discrepancy, HOOS
- Medical subject headings
- Leg Length Inequality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip arthroplastyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anatomic lower limb length measurements between preoperative and postoperative measurements
Measured: preoperative measurements (up to 1 year before surgery) and postoperative measurements (at 1 month after surgery)
Secondary outcomes (2)
Change in flessum/recurvatum/HKS angle (hip knee shaft ) measurements, between preoperative and postoperative measurements
Measured: 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)]
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jan 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Région Ile de France, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437343
- Sponsor's protocol ID
- NI17039J
- Other IDs
- 2017-A03333-50
- Acronym
- EOS-PTH
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03437343
- Acronym / sponsor ID
- EOS-PTH / NI17039J
- Conditions
- Total Hip Arthroplasty
- Keywords
- EOS, total hip arthroplasty, performance of surgeons, leg length discrepancy, HOOS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Région Ile de France, France
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted in patients who underwent a total hip arthroplasty in Lariboisiere Hospital, Paris, France, during the year 2015.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- past history of contralateral hip replacement
- ipsi or contralateral knee replacement
- hip arthroplasty performed using a Kerboull cross
- post-operative complications such as infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip arthroplasty | Procedure or surgery | – |
Primary outcome
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)
2 secondary outcomes
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)
Time frame: 24 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.