Transverse Fracture of AcetabulumFracture_TransNCT04741347
Predictors of the Quality of Surgical Reduction and Long-term Outcome
An observational study of Transverse Fracture of Acetabulum, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge. In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transverse Fracture of Acetabulum
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2021to 11 Sep 2023
- 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
- Adult, Older adult
Study population: Patients were treated for transverse fractures +/- posterior wall of the acetabulum within the Paris Saint-Joseph Hospital Group, between 2006 and 2020.
Who may be able to join
- Patient whose age is ≥ 18 years
- Patient with transverse fractures +/- posterior wall of the acetabulum
- Patient cared for at Paris Saint-Joseph Hospital, between 2006 and 2020
- French-speaking patient
Who cannot join
- Patient under guardianship or curatorship
- Patient under legal protection
- Patient deprived of liberty
- Patient not operated
- Patient with an undisplaced fracture
- Patient who did not have a post-operative control scan
- Patient objecting to the use of their data for this research
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transverse Fractures +/- Posterior Wall of the Acetabulum: Predictors of the Quality of Surgical Reduction and Long-term Outcome
Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge.
In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. However, this reduction must be a major priority since it is one of the factors conditioning the functional result.
Read more
In our study, we wish to analyze a particular type of fracture, less studied, or with small series, that are the transverse fractures (+/- posterior wall), known for their difficulty of reduction. The reduction is even greater as the fracture line often passes through the acetabular bearing zone, compromising the functional prognosis.
The choice of surgical approach for this type of fracture is controversial. More and more, a single approach, usually posterior, without compulsory fixation of the anterior component of the transverse fracture is preferred over the traditional double approach anterior and posterior, and this in particular to reduce the morbidity of this surgery.
But this one-size-fits-all approach does not always achieve a good reduction and it is believed that the time to surgery may play a role.
If it is accepted that the surgical delay before reduction in osteosynthesis of an acetabular fracture is involved in the quality of the reduction and therefore the functional result in these patients, the question asked is whether this delay should condition the choice of a double approach, anterior and posterior, for this type of fracture (transverse +/- posterior wall).
Indeed, with increasing surgical time, the risk of scar tissue formation and early callus increases, making bone fragments less mobile, reduction more difficult and indirect reduction techniques (which are used when single approach is chosen) less efficient.
In addition, most of the studies evaluating the quality of reduction of acetabular fractures use a radiographic score, that of Matta.
However, it has been shown that the CT scan was more efficient than the x-rays in detecting a residual displacement of the fracture. Also, in this study, we want to analyze the quality of reduction thanks to the scanner, which is rarely done in the literature.
This work aims to determine the predictive factors of the quality of reduction of transverse fractures +/- posterior wall of the acetabulum, evaluated on the postoperative CT scan.
- Conditions
- Transverse Fracture of Acetabulum
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture reduction quality
This outcome corresponds to the fracture reduction quality assessed on the postoperative CT scan using the Saint Joseph score.
Measured: Year 1
Secondary outcomes (1)
Complication rate
This outcome corresponds to the rate of postoperative complications (infection, hematoma, anemia requiring transfusion, neurological complications (e.g. sciatic nerve injury)).
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start3 Feb 2021
- Primary completion3 Mar 2021
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transverse Fracture of AcetabulumStudies 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume RIOUALLON, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04741347
- Sponsor's protocol ID
- Fracture_Trans
- Acronym
- Fracture_Trans
- Status last verified
- Sep 2022
- First submitted
- 3 Feb 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
PubMed 8934477Madhu R, Kotnis R, Al-Mousawi A, Barlow N, Deo S, Worlock P, Willett K. Outcome of surgery for reconstruction of fractures of the acetabulum. The time dependent effect of delay. J Bone Joint Surg Br. 2006 Sep;88(9):1197-203. doi: 10.1302/0301-620X.88B9.17588.
PubMed 16943472Giordano V, do Amaral NP, Pallottino A, Pires e Albuquerque R, Franklin CE, Labronici PJ. Operative treatment of transverse acetabular fractures: is it really necessary to fix both columns? Int J Med Sci. 2009 Jul 12;6(4):192-9. doi: 10.7150/ijms.6.192.
PubMed 19652723Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.
PubMed 29040129
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Fractures +/- Posterior Wall of the Acetabulum: Predictors of the Quality of Surgical Reduction and Long-term Outcome
- ClinicalTrials.gov ID
- NCT04741347
- Acronym / sponsor ID
- Fracture_Trans / Fracture_Trans
- Conditions
- Transverse Fracture of Acetabulum
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 5 Feb 2021 (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.
Acetabulum fractures are complex, relatively rare lesions linked to a more or less good functional prognosis and therefore represent a real surgical challenge.
In the literature, it is accepted that surgical delay, among other things, negatively impacts the quality of surgical reduction. However, this reduction must be a major priority since it is one of the factors conditioning the functional result.
In our study, we wish to analyze a particular type of fracture, less studied, or with small series, that are the transverse fractures (+/- posterior wall), known for their difficulty of reduction. The reduction is even greater as the fracture line often passes through the acetabular bearing zone, compromising the functional prognosis.
The choice of surgical approach for this type of fracture is controversial. More and more, a single approach, usually posterior, without compulsory fixation of the anterior component of the transverse fracture is preferred over the traditional double approach anterior and posterior, and this in particular to reduce the morbidity of this surgery.
But this one-size-fits-all approach does not always achieve a good reduction and it is believed that the time to surgery may play a role.
If it is accepted that the surgical delay before reduction in osteosynthesis of an acetabular fracture is involved in the quality of the reduction and therefore the functional result in these patients, the question asked is whether this delay should condition the choice of a double approach, anterior and posterior, for this type of fracture (transverse +/- posterior wall).
Indeed, with increasing surgical time, the risk of scar tissue formation and early callus increases, making bone fragments less mobile, reduction more difficult and indirect reduction techniques (which are used when single approach is chosen) less efficient.
In addition, most of the studies evaluating the quality of reduction of acetabular fractures use a radiographic score, that of Matta.
However, it has been shown that the CT scan was more efficient than the x-rays in detecting a residual displacement of the fracture. Also, in this study, we want to analyze the quality of reduction thanks to the scanner, which is rarely done in the literature.
This work aims to determine the predictive factors of the quality of reduction of transverse fractures +/- posterior wall of the acetabulum, evaluated on the postoperative CT scan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were treated for transverse fractures +/- posterior wall of the acetabulum within the Paris Saint-Joseph Hospital Group, between 2006 and 2020.
Key inclusion criteria (4 listed)
- Patient whose age is ≥ 18 years
- Patient with transverse fractures +/- posterior wall of the acetabulum
- Patient cared for at Paris Saint-Joseph Hospital, between 2006 and 2020
- French-speaking patient
Key exclusion criteria (7 listed)
- Patient under guardianship or curatorship
- Patient under legal protection
- Patient deprived of liberty
- Patient not operated
- Patient with an undisplaced fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fracture reduction quality
Time frame: Year 1
This outcome corresponds to the fracture reduction quality assessed on the postoperative CT scan using the Saint Joseph score.
1 secondary outcome
Complication rate
Time frame: Year 1
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 13 Sep 2023.
- Results publication: PubMed 8934477Matta JM. Fractures of the acetabulum: accuracy of reduction and clinical results in patients managed operatively within three weeks after the injury. J Bone Joint Surg Am. 1996 Nov;78(11):1632-45.
- Results publication: PubMed 16943472Madhu R, Kotnis R, Al-Mousawi A, Barlow N, Deo S, Worlock P, Willett K. Outcome of surgery for reconstruction of fractures of the acetabulum. The time dependent effect of delay. J Bone Joint Surg Br. 2006 Sep;88(9):1197-203. doi: 10.1302/0301-620X.88B9.17588.
- Results publication: PubMed 19652723Giordano V, do Amaral NP, Pallottino A, Pires e Albuquerque R, Franklin CE, Labronici PJ. Operative treatment of transverse acetabular fractures: is it really necessary to fix both columns? Int J Med Sci. 2009 Jul 12;6(4):192-9. doi: 10.7150/ijms.6.192.
- Results publication: PubMed 29040129Verbeek DO, van der List JP, Villa JC, Wellman DS, Helfet DL. Postoperative CT Is Superior for Acetabular Fracture Reduction Assessment and Reliably Predicts Hip Survivorship. J Bone Joint Surg Am. 2017 Oct 18;99(20):1745-1752. doi: 10.2106/JBJS.16.01446.
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.
Guillaume RIOUALLON, 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 Transverse Fracture of Acetabulum, 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 4 inclusion and 7 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 13 Sep 2023. 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?
Fracture reduction quality (time frame: Year 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04741347, which also lists 4 linked publications.
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 13 Sep 2023.