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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06209255
Other study ID # VanBEAH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 11, 2020
Est. completion date August 11, 2023

Study information

Verified date January 2024
Source Van Bölge Egitim ve Arastirma Hastanesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This observational study aims to learn about the outcomes in the previously operated patient and whether pelvic bone rearrangement surgery was a success. The main question it aims to answer is: • Should the investigators perform pelvic rearrangement surgery on a patient if there's not enough bone stock to accomplish the exchange of the components? As the research started the participant was asked to attend outpatient clinics regularly and keep in touch. The investigators were able to observe the outcomes and closely explore probable risks for failure.


Description:

A 56-year-old female patient had a hip operation one year previously and experienced her first dislocation two months postoperatively. The patient underwent closed reduction three times. The patient presented to us due to a fourth hip dislocation that had occurred one month previously. Hip X-ray images revealed acetabular component malposition, with an 80-degree inclination and 20 degrees of cup anteversion with a posterior hip dislocation. The investigators treated the patient via pelvic osteotomy, using a modified Stoppa approach to reduce acetabular inclination. The patient had no dislocation at the 2-year follow-up. At the last follow-up, the Harris Hip Score was 85.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date August 11, 2023
Est. primary completion date August 11, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Previously Replaced Total Hip - Minimum 1-year follow-up - 18-45 years, both sexes - otherwise healthy Exclusion Criteria: - Any debilitating disorder - Neurological or genetic disorders - Pediatric or geriatric age

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pelvic Osteotomy - Ganz Procedure
Ischial osteotomy was performed on the pubic arch; this was followed by iliac osteotomy, performed using Schanz screws in the iliac wing. The osteotomized acetabulum was overturned, and inclination was reduced.

Locations

Country Name City State
Turkey VanBEAH VAN

Sponsors (1)

Lead Sponsor Collaborator
Van Bölge Egitim ve Arastirma Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

Alberton GM, High WA, Morrey BF. Dislocation after revision total hip arthroplasty : an analysis of risk factors and treatment options. J Bone Joint Surg Am. 2002 Oct;84(10):1788-92. — View Citation

Ballester Alfaro JJ, Sueiro Fernandez J. Trabecular Metal buttress augment and the Trabecular Metal cup-cage construct in revision hip arthroplasty for severe acetabular bone loss and pelvic discontinuity. Hip Int. 2010;20 Suppl 7:S119-27. doi: 10.1177/11207000100200s720. Epub 2010 May 27. — View Citation

DeBoer DK, Christie MJ, Brinson MF, Morrison JC. Revision total hip arthroplasty for pelvic discontinuity. J Bone Joint Surg Am. 2007 Apr;89(4):835-40. doi: 10.2106/JBJS.F.00313. — View Citation

Dennis DA. Management of massive acetabular defects in revision total hip arthroplasty. J Arthroplasty. 2003 Apr;18(3 Suppl 1):121-5. doi: 10.1054/arth.2003.50105. — View Citation

Guo L, Yang Y, An B, Yang Y, Shi L, Han X, Gao S. Risk factors for dislocation after revision total hip arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Feb;38:123-129. doi: 10.1016/j.ijsu.2016.12.122. Epub 2016 Dec 31. — View Citation

Kocabiyik A, Misir A, Kizkapan TB, Yildiz KI, Kaygusuz MA, Alpay Y, Ezici A. Changes in Hip, Knee, and Ankle Coronal Alignments After Total Hip Arthroplasty With Transverse Femoral Shortening Osteotomy for Unilateral Crowe Type IV Developmental Dysplasia of the Hip. J Arthroplasty. 2017 Nov;32(11):3449-3456. doi: 10.1016/j.arth.2017.05.044. Epub 2017 Jun 1. — View Citation

Malahias MA, Ma QL, Gu A, Ward SE, Alexiades MM, Sculco PK. Outcomes of Acetabular Reconstructions for the Management of Chronic Pelvic Discontinuity: A Systematic Review. J Arthroplasty. 2020 Apr;35(4):1145-1153.e2. doi: 10.1016/j.arth.2019.10.057. Epub 2019 Nov 4. — View Citation

Paprosky WG, Perona PG, Lawrence JM. Acetabular defect classification and surgical reconstruction in revision arthroplasty. A 6-year follow-up evaluation. J Arthroplasty. 1994 Feb;9(1):33-44. doi: 10.1016/0883-5403(94)90135-x. — View Citation

Sadhu A, Nam D, Coobs BR, Barrack TN, Nunley RM, Barrack RL. Acetabular Component Position and the Risk of Dislocation Following Primary and Revision Total Hip Arthroplasty: A Matched Cohort Analysis. J Arthroplasty. 2017 Mar;32(3):987-991. doi: 10.1016/j.arth.2016.08.008. Epub 2016 Aug 20. — View Citation

Sheth NP, Nelson CL, Springer BD, Fehring TK, Paprosky WG. Acetabular bone loss in revision total hip arthroplasty: evaluation and management. J Am Acad Orthop Surg. 2013 Mar;21(3):128-39. doi: 10.5435/JAAOS-21-03-128. — View Citation

Yetkin C, Yildirim T, Alpay Y, Tas SK, Buyukkuscu MO, Dirvar F. Evaluation of Dislocation Risk Factors With Total Hip Arthroplasty in Developmental Hip Dysplasia Patients: A Multivariate Analysis. J Arthroplasty. 2021 Feb;36(2):636-640. doi: 10.1016/j.arth.2020.08.043. Epub 2020 Aug 29. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Harris Hip Score Higher scores, the better. 3 years
Secondary Visual Analogue Score Lower the scores, the better. 3 years
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