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Acetabular FractureNCT03152266

Function Outcome of Impaction Injuries in Acetabular Fractures

An observational study of Acetabular Fracture, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Acetabular Fracture
How many people
42 participants
Where
1 siteEgypt
Study dates
1 Jun 2017to 30 Jun 2022
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • Traumatic Osteochondral impaction injuries of the acetabulum (marginal and dome ).
  • Pure impaction without cortical interruption
  • Closed fractures.
  • Skeletally mature (adults and elderly).

Who cannot join

  • Fractures in skeletally immature patients.
  • Pathological fractures .
  • Associated proximal Hip fractures.
  • Open acetabular Fractures.
  • Fractures more than 3 weeks

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut faculty of medicine

    Asyut, 71111

Other trials in Egypt

About this study

Official title: 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.

Read the 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.

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

    Follow up of the function of the hip after reduction of the impacted fragment which associated with acetabular fractures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. modified Merle d'Aubigne and Postel scoring

    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.

    Measured: 6th month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2017
  2. Study start1 Jun 2017
  3. Primary completion1 Jun 2021
  4. Study completion30 Jun 2022

Resources

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
Prospective
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03152266
Sponsor's protocol ID
OCIA
Status last verified
Jun 2022
First submitted
11 May 2017
Last updated
1 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25794097

  • 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.

    PubMed 12882675

  • 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.

    PubMed 23684351

  • 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.

    PubMed 12004016

  • 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.

    PubMed 17159175

  • 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.

    PubMed 23365034

  • 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.

    PubMed 14563792

  • 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.

    PubMed 24453605

  • 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.

    PubMed 16720773

  • 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.

    PubMed 27792674

  • 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.

    PubMed 23452418

  • 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.

    PubMed 20728882

  • 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.

    PubMed 26033996

  • 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.

    PubMed 1457419

  • 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.

    PubMed 23681409

Questions about this trial

What is this clinical trial studying?

An observational study of Acetabular Fracture, run by Assiut University at 1 site in Egypt.

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 5 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 1 Jul 2022. 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 Egypt. 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?

modified Merle d'Aubigne and Postel scoring (time frame: 6th month). 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 NCT03152266, which also lists 21 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 1 Jul 2022.

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