Total HipPTHPOSTCOTYLNCT02892240
Retrospective Evaluation of Total Hip Replacement After Acetabular Fractures
An observational study of Total Hip and Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still relevant and in use today. Many studies have sought to determine if the treatment had to be surgical or orthopedic. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip, Acetabular Fracture
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 31 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have had a fracture of the acetabulum ostéosynthèsée treated conservatively or who had a total hip replacement by secondary intention, operated at St. Joseph's Hospital between 2005 and 2013
Who may be able to join
- Patients who have had a fracture of the acetabulum ostéosynthèsée treated conservatively or who had a total hip replacement by secondary intention.
- Operated at St. Joseph's Hospital between 2005 and 2013
- Decline minimum of one year.
Who cannot join
- Total first-line hip arthroplasty following fracture of the acetabulum made within two months following the date of the initial trauma.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still relevant and in use today.
Many studies have sought to determine if the treatment had to be surgical or orthopedic. Although the standard treatment of displaced fractures of the acetabulum is the reduction and osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of the articular surface and including bearing zone. All these treatments and those supported have been studied in the literature.
Read more
However the study of the laying of total hip remote trauma after acetabular fracture osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have been published in recent years.
Indeed, a recent review of the literature are nearly 11 series focusing on the results remotely hip prostheses for treatment of acetabular fracture. These two prospective series with between 21 and 63 patients. All authors report rates well above those reported complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.
Fractures of the acetabulum are covered in our service by one operator using the same release technique based on the stiffening. The objective of this study is to determine whether the systematic surgical treatment of these patients by an experienced operator reduces the high complication rate.
Read the detailed description
II. objectives:
- Evaluation of the rate and type of complications intraoperative and postoperative, and revision rates.
- Evaluation of clinical results based on surgical strategies.
III. Methodology
This is a single-center retrospective study single-operator regarding the evaluation of surgical practice cited in goal.
Patients were aware of the potential use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.
IV. Nature of the data collected
The data is anonymous and unidentifiable.
Data collected include:
- The characteristics of the patient, as well as its history,
- The particular technical operating data,
- The nature of possible post-operative complications
- The clinical and radiological assessment at follow: AP pelvic radiograph, Harris score and score Postel Merle D'aubigné.
- Conditions
- Total Hip, Acetabular Fracture
- Being tested
- No intervention. Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Observational studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the success of the surgical strategy
According to the surgery strategy adopted, the investigators will response to the simple question. Success or not success?
Measured: month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total HipStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pomme P JOUFFROY, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892240
- Sponsor's protocol ID
- PTHPOSTCOTYL
- Acronym
- PTHPOSTCOTYL
- Status last verified
- Feb 2020
- First submitted
- 2 Sep 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Evaluation of Total Hip Replacement After Acetabular Fractures
- ClinicalTrials.gov ID
- NCT02892240
- Acronym / sponsor ID
- PTHPOSTCOTYL / PTHPOSTCOTYL
- Conditions
- Total Hip, Acetabular Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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.
In 1965, Emile Letournel and Robert Judet reported their experiences on acetabular fractures at the 5th day of the Raymond Poincaré Hospital in Garches. Classification Letournel is still relevant and in use today.
Many studies have sought to determine if the treatment had to be surgical or orthopedic. Although the standard treatment of displaced fractures of the acetabulum is the reduction and osteosynthesis, some advocate the THA in elderly patients with comminuted fracture of the acetabulum, impaction of the femoral head or acetabular impaction affecting more than 40% of the articular surface and including bearing zone. All these treatments and those supported have been studied in the literature.
However the study of the laying of total hip remote trauma after acetabular fracture osteosynthesis or treated conservatively, is not rich in literature. Only a few articles have been published in recent years.
Indeed, a recent review of the literature are nearly 11 series focusing on the results remotely hip prostheses for treatment of acetabular fracture. These two prospective series with between 21 and 63 patients. All authors report rates well above those reported complications for primary arthroplasty, with a revision of rates ranging between 0 and 26.5%.
Fractures of the acetabulum are covered in our service by one operator using the same release technique based on the stiffening. The objective of this study is to determine whether the systematic surgical treatment of these patients by an experienced operator reduces the high complication rate.
Detailed description
II. objectives:
- Evaluation of the rate and type of complications intraoperative and postoperative, and revision rates.
- Evaluation of clinical results based on surgical strategies.
III. Methodology
This is a single-center retrospective study single-operator regarding the evaluation of surgical practice cited in goal.
Patients were aware of the potential use of their data for medical research through oral information provided by the doctor at the signing by the patient's consent related to the surgery.
IV. Nature of the data collected
The data is anonymous and unidentifiable.
Data collected include:
- The characteristics of the patient, as well as its history,
- The particular technical operating data,
- The nature of possible post-operative complications
- The clinical and radiological assessment at follow: AP pelvic radiograph, Harris score and score Postel Merle D'aubigné.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have had a fracture of the acetabulum ostéosynthèsée treated conservatively or who had a total hip replacement by secondary intention, operated at St. Joseph's Hospital between 2005 and 2013
Key inclusion criteria (3 listed)
- Patients who have had a fracture of the acetabulum ostéosynthèsée treated conservatively or who had a total hip replacement by secondary intention.
- Operated at St. Joseph's Hospital between 2005 and 2013
- Decline minimum of one year.
Key exclusion criteria (1 listed)
- Total first-line hip arthroplasty following fracture of the acetabulum made within two months following the date of the initial trauma.
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 |
|---|---|---|
| No intervention. Observational study | Other | – |
Primary outcome
Assessment of the success of the surgical strategy
Time frame: month 6
According to the surgery strategy adopted, the investigators will response to the simple question. Success or not success?
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 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
Pomme P JOUFFROY, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip and Acetabular Fracture, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 3 inclusion and 1 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of the success of the surgical strategy (time frame: month 6). 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 5 Feb 2020.