NCT03152266

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

4 years

First QC Date

May 11, 2017

Last Update Submit

June 30, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    6th month

Interventions

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

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut faculty of medicine

Asyut, 71111, Egypt

Location

Related Publications (21)

  • 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.

    PMID: 25794097BACKGROUND
  • 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.

    PMID: 12882675BACKGROUND
  • 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.

    PMID: 23684351BACKGROUND
  • 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.

    PMID: 12004016BACKGROUND
  • 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.

    PMID: 17159175BACKGROUND
  • 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.

    PMID: 23365034BACKGROUND
  • 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.

    PMID: 14563792BACKGROUND
  • 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.

    PMID: 24453605BACKGROUND
  • 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.

    PMID: 16720773BACKGROUND
  • 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.

    PMID: 27792674BACKGROUND
  • 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.

    PMID: 23452418BACKGROUND
  • 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.

    PMID: 20728882BACKGROUND
  • 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.

    PMID: 26033996BACKGROUND
  • 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.

    PMID: 1457419BACKGROUND
  • 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.

    PMID: 23681409BACKGROUND
  • 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.

    PMID: 27499274BACKGROUND
  • 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.

    PMID: 23916899BACKGROUND
  • 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.

    PMID: 25486005BACKGROUND
  • 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.

    PMID: 21926638BACKGROUND
  • 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.

    PMID: 24296594BACKGROUND
  • 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.

    PMID: 23940014BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

June 1, 2017

Primary Completion

June 1, 2021

Study Completion

June 30, 2022

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations