- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03152266
Function Outcome of Impaction Injuries in Acetabular Fractures
June 30, 2022 updated by: Bahaaeldin Mohamed Abdelhafez, Assiut University
Short-Term Outcome of Surgical Treatment of Osteochondral Impaction in Acetabular Fractures
Is the anatomical reduction of osteochondral impaction in the acetabular fractures will improve the functional outcome?
Despite the increasing amount of literature related to the management of anteromedial dome impactions and marginal impactions, there are still remaining issues and controversies pertaining mainly to the exact anatomy and location of the lesion, the best method of reduction, the need and type of subchondral void filling, the best method of stabilization, the need of reduction in elderly population and its true value as an outcome prognostic factor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The reduction of the impacted fragment done through many ways and techniques , all acetabular approaches can be used to reach to the impacted part or through independent cortical window, The impacted part can be reached through the fracture itself as in marginal impaction through the posterior wall and in anteromedial impaction through the quadrilateral plate.
Then using a bone graft as a void filling which can be taken from iliac bone or greater trochanter.
Post-operative x-rays and computed tomography scan will be done to all patients , Radiological grading immediate post-operative and at the last follow-up according to Matta , Heterotopic ossification will be classified according to the Brooker classes on an Anteroposterior radiograph, Posttraumatic arthritis will be evaluated according to the method by Kellgren and Lawrence, functional outcome will be assessed according to Merle D'Aubigne and Postel scoring which was modified by Matta, Avascular necrosis of hips will be classified according to Ficat and Arlet classification.
Study Type
Observational
Enrollment (Actual)
42
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt, 71111
- Assiut Faculty of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients will be admitted at emergency department of assiut university hospital , ATLS protocol will be applied , preoperaive plane xray (anteroposterior and CT scan will be done)post operative x rays and CT scan will be done to all patients , Radiological grading just post-operative at the last follow-up according to Matta, Heterotopic ossification was classified according to the Brooker classes on an AP radiograph, Posttraumatic arthritis was evaluated according to the method by Kellgren and Lawrence, functional outcome will be assessed according to Merle d'Aubigne and Postel scoring which was modified by Matta, Avascular necrosis of hips was classified according to Ficat and Arlet classification
Description
Inclusion Criteria:
- Traumatic Osteochondral impaction injuries of the acetabulum (marginal and dome ).
- Pure impaction without cortical interruption
- Closed fractures.
- Skeletally mature (adults and elderly).
Exclusion Criteria:
- Fractures in skeletally immature patients.
- Pathological fractures .
- Associated proximal Hip fractures.
- Open acetabular Fractures.
- Fractures more than 3 weeks
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
modified Merle d'Aubigne and Postel scoring
Time Frame: 6th month
|
The modified Merle D'Aubigné clinical hip score is the most generally accepted clinical grading system for evaluating the results of acetabular fracture treatment , which evaluates pain, gait and mobility, on a scale.
|
6th month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Martins e Souza P, Giordano V, Goldsztajn F, Siciliano AA, Grizendi JA, Dias MV. Marginal impaction in posterior wall fractures of the acetabulum. AJR Am J Roentgenol. 2015 Apr;204(4):W470-4. doi: 10.2214/AJR.14.12451.
- Wu XB, Wang MY, Zhu SW, Cao QY, Wu HH. [Marginal impaction in acetabular fractures]. Zhonghua Wai Ke Za Zhi. 2003 Apr;41(4):289-91. Chinese.
- Leucht P, Castillo AB, Bellino MJ. Comparison of tricalcium phosphate cement and cancellous autograft as bone void filler in acetabular fractures with marginal impaction. Injury. 2013 Jul;44(7):969-74. doi: 10.1016/j.injury.2013.04.017. Epub 2013 May 14.
- Moed BR, WillsonCarr SE, Watson JT. Results of operative treatment of fractures of the posterior wall of the acetabulum. J Bone Joint Surg Am. 2002 May;84(5):752-8. doi: 10.2106/00004623-200205000-00008.
- Bhandari M, Matta J, Ferguson T, Matthys G. Predictors of clinical and radiological outcome in patients with fractures of the acetabulum and concomitant posterior dislocation of the hip. J Bone Joint Surg Br. 2006 Dec;88(12):1618-24. doi: 10.1302/0301-620X.88B12.17309.
- Giannoudis PV, Kanakaris NK, Delli Sante E, Morell DJ, Stengel D, Prevezas N. Acetabular fractures with marginal impaction: mid-term results. Bone Joint J. 2013 Feb;95-B(2):230-8. doi: 10.1302/0301-620X.95B2.30548.
- Moed BR, Yu PH, Gruson KI. Functional outcomes of acetabular fractures. J Bone Joint Surg Am. 2003 Oct;85(10):1879-83. doi: 10.2106/00004623-200310000-00002.
- Ugino FK, Righetti CM, Alves DP, Guimaraes RP, Honda EK, Ono NK. Evaluation of the reliability of the modified Merle d'Aubigne and Postel Method. Acta Ortop Bras. 2012;20(4):213-7. doi: 10.1590/S1413-78522012000400004.
- Kreder HJ, Rozen N, Borkhoff CM, Laflamme YG, McKee MD, Schemitsch EH, Stephen DJ. Determinants of functional outcome after simple and complex acetabular fractures involving the posterior wall. J Bone Joint Surg Br. 2006 Jun;88(6):776-82. doi: 10.1302/0301-620X.88B6.17342.
- Manson T, Schmidt AH. Acetabular Fractures in the Elderly: A Critical Analysis Review. JBJS Rev. 2016 Oct 4;4(10):e1. doi: 10.2106/JBJS.RVW.15.00090.
- Gansslen A, Hildebrand F, Kretek C. Transverse + posterior wall fractures of the acetabulum: epidemiology, operative management and long-term results. Acta Chir Orthop Traumatol Cech. 2013;80(1):27-33.
- Giannoudis PV, Tzioupis C, Papathanassopoulos A, Obakponovwe O, Roberts C. Articular step-off and risk of post-traumatic osteoarthritis. Evidence today. Injury. 2010 Oct;41(10):986-95. doi: 10.1016/j.injury.2010.08.003.
- Zhuang Y, Lei JL, Wei X, Lu DG, Zhang K. Surgical treatment of acetabulum top compression fracture with sea gull sign. Orthop Surg. 2015 May;7(2):146-54. doi: 10.1111/os.12175.
- Bertrand R, Derancourt J, Kassab R. Molecular movements in the actomyosin complex: F-actin-promoted internal cross-linking of the 25- and 20-kDa heavy chain fragments of skeletal myosin subfragment. Biochemistry. 1992 Dec 8;31(48):12219-26. doi: 10.1021/bi00163a035.
- Laflamme GY, Hebert-Davies J. Direct reduction technique for superomedial dome impaction in geriatric acetabular fractures. J Orthop Trauma. 2014 Feb;28(2):e39-43. doi: 10.1097/BOT.0b013e318298ef0a.
- Tosounidis TH, Stengel D, Giannoudis PV. Anteromedial dome impaction in acetabular fractures: Issues and controversies. Injury. 2016 Aug;47(8):1605-7. doi: 10.1016/j.injury.2016.07.020. No abstract available.
- Scolaro JA, Routt ML Jr. Reduction of osteoarticular acetabular dome impaction through an independent iliac cortical window. Injury. 2013 Dec;44(12):1959-64. doi: 10.1016/j.injury.2013.07.012. Epub 2013 Aug 2. No abstract available.
- Collinge CA, Lebus GF. Techniques for reduction of the quadrilateral surface and dome impaction when using the anterior intrapelvic (modified Stoppa) approach. J Orthop Trauma. 2015 Feb;29 Suppl 2:S20-4. doi: 10.1097/BOT.0000000000000271.
- Jeffcoat DM, Carroll EA, Huber FG, Goldman AT, Miller AN, Lorich DG, Helfet DL. Operative treatment of acetabular fractures in an older population through a limited ilioinguinal approach. J Orthop Trauma. 2012 May;26(5):284-9. doi: 10.1097/BOT.0b013e31821e10a2.
- Casstevens C, Archdeacon MT, d'Heurle A, Finnan R. Intrapelvic reduction and buttress screw stabilization of dome impaction of the acetabulum: a technical trick. J Orthop Trauma. 2014 Jun;28(6):e133-7. doi: 10.1097/BOT.0000000000000005.
- Lubovsky O, Kreder M, Wright DA, Kiss A, Gallant A, Kreder HJ, Whyne CM. Quantitative measures of damage to subchondral bone are associated with functional outcome following treatment of displaced acetabular fractures. J Orthop Res. 2013 Dec;31(12):1980-5. doi: 10.1002/jor.22458. Epub 2013 Aug 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ACTUAL)
June 1, 2021
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
May 11, 2017
First Submitted That Met QC Criteria
May 12, 2017
First Posted (ACTUAL)
May 15, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 1, 2022
Last Update Submitted That Met QC Criteria
June 30, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCIA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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