- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04741347
Predictors of the Quality of Surgical Reduction and Long-term Outcome (Fracture_Trans)
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fracture reduction quality
Time Frame: Year 1
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This outcome corresponds to the fracture reduction quality assessed on the postoperative CT scan using the Saint Joseph score.
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Year 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication rate
Time Frame: Year 1
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This outcome corresponds to the rate of postoperative complications (infection, hematoma, anemia requiring transfusion, neurological complications (e.g.
sciatic nerve injury)).
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Year 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Guillaume RIOUALLON, MD, Fondation Hôpital Saint-Joseph
Publications and helpful links
General 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.
- Verbeek 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.
- Madhu 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.
- Giordano 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fracture_Trans
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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