Closed the single investigator initiated study at request of Stryker, to begin collecting as a multicenter study.
Survivorship, Clinical and Functional Outcomes of the Multihole Revision Acetabular Cup
Sponsor study identifier
observational
24
1 country
1
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2022
Actual (reported)Study Completion
January 2022
Actual (reported)This study will evaluate patients receiving a multihole revision acetabular implant for total hip arthroplasty (THA) and will be followed for 10 years to collect data on survivorship of the implanted prosthesis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
December 20, 2016
Actual (reported)January 26, 2017
Actual (reported)January 2022
Actual (reported)January 2022
Actual (reported)survivorship of a multihole revision acetabular cup
evaluate standard of care radiographs for any signs of implant compromise such as loosening or osteolysis
10 years
Clinical outcomes of multihole revision acetabular cup
10 years
functional outcomes of multihole revision acetabular cup
10 years
assess pain levels in patients who receive multihole revision acetabular cup
10 years
Revision total hip arthroplasty using multihole revision acetabular cup
post market study of multi hole revision acetabular cup
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients requiring a revision total hip arthroplasty
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Jafari SM, Bender B, Coyle C, Parvizi J, Sharkey PF, Hozack WJ. Do tantalum and titanium cups show similar results in revision hip arthroplasty? Clin Orthop Relat Res. 2010 Feb;468(2):459-65. doi: 10.1007/s11999-009-1090-5.
Kremers HM, Howard JL, Loechler Y, Schleck CD, Harmsen WS, Berry DJ, Cabanela ME, Hanssen AD, Pagnano MW, Trousdale RT, Lewallen DG. Comparative long-term survivorship of uncemented acetabular components in revision total hip arthroplasty. J Bone Joint Surg Am. 2012 Jun 20;94(12):e82. doi: 10.2106/JBJS.K.00549.
Carlos Higuera, MD
The Cleveland Clinic
24 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2016
First Posted
January 26, 2017
Study Start
December 2016
Date type not reportedThis date has not been verified as actual or estimated.
Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
Contact the study team to confirm eligibility.
Unger AS, Lewis RJ, Gruen T. Evaluation of a porous tantalum uncemented acetabular cup in revision total hip arthroplasty: clinical and radiological results of 60 hips. J Arthroplasty. 2005 Dec;20(8):1002-9. doi: 10.1016/j.arth.2005.01.023.
Odri GA, Padiolleau GB, Gouin FT. Oversized cups as a major risk factor of postoperative pain after total hip arthroplasty. J Arthroplasty. 2014 Apr;29(4):753-6. doi: 10.1016/j.arth.2013.07.001. Epub 2013 Aug 6.
Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
Silverton CD, Rosenberg AG, Sheinkop MB, Kull LR, Galante JO. Revision total hip arthroplasty using a cementless acetabular component. Technique and results. Clin Orthop Relat Res. 1995 Oct;(319):201-8.
Petrera P, Rubash HE. Revision Total Hip Arthroplasty: The Acetabular Component. J Am Acad Orthop Surg. 1995 Jan;3(1):15-21. doi: 10.5435/00124635-199501000-00003.
Klika AK, Murray TG, Darwiche H, Barsoum WK. Options for acetabular fixation surfaces. J Long Term Eff Med Implants. 2007;17(3):187-92. doi: 10.1615/jlongtermeffmedimplants.v17.i3.20.
Ramappa M, Bajwa A, Kulkarni A, McMurtry I, Port A. Early results of a new highly porous modular acetabular cup in revision arthroplasty. Hip Int. 2009 Jul-Sep;19(3):239-44. doi: 10.1177/112070000901900309.
Frenkel SR, Jaffe WL, Dimaano F, Iesaka K, Hua T. Bone response to a novel highly porous surface in a canine implantable chamber. J Biomed Mater Res B Appl Biomater. 2004 Nov 15;71(2):387-91. doi: 10.1002/jbm.b.30104.
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.
Claus AM, Engh CA Jr, Sychterz CJ, Xenos JS, Orishimo KF, Engh CA Sr. Radiographic definition of pelvic osteolysis following total hip arthroplasty. J Bone Joint Surg Am. 2003 Aug;85(8):1519-26. doi: 10.2106/00004623-200308000-00013.
Primary Completion
January 2022
Actual (reported)Study Completion
January 2022
Actual (reported)Last Updated
January 28, 2022
Record last verified: 2022-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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