Survivorship, Radiographic, and Functional Outcomes of the Multihole Revision Acetabular Cup

NCT03031964 | Terminated

• 1 other identifier: #16-1030
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complications Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

revision multihole acetabular cup

Revision total hip arthroplasty using multihole revision acetabular cup

Device: revision multihole acetabular cup

Interventions

revision multihole acetabular cup DEVICE

post market study of multi hole revision acetabular cup

Also known as: Stryker restoration anatomic shell

revision multihole acetabular cup

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring a revision total hip arthroplasty

You may qualify if:

• Patients requiring revision total hip replacement of the acetabular component or complicated primary total hip replacement.
• Femoral stem (either retained or replaced) is a compatible Stryker stem.
• Patient is willing to comply with follow-up requirements (e.g. will return for long-term follow-up visits)
• Age: 18-85 years

You may not qualify if:

• Patient has a BMI \> 40
• Exclude revision for infection
• Patient is undergoing bilateral THA surgery or had prior hip arthroplasty on contralateral side less than 6 months from date of surgery
• Patient has history of radiation therapy
• Patient has known diagnosis of renal disease
• Patient has known diagnosis of osteoporosis

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (12)

• 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.

  PMID: 19809857 BACKGROUND

• 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.

  PMID: 22717834 BACKGROUND

• 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.

  PMID: 16376255 BACKGROUND

• 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.

  PMID: 23927907 BACKGROUND

• 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.

  PMID: 17403800 BACKGROUND

• 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.

  PMID: 7554631 BACKGROUND

• 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.

  PMID: 10790649 BACKGROUND

• 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.

  PMID: 19023943 BACKGROUND

• 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.

  PMID: 19876878 BACKGROUND

• 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.

  PMID: 15389510 BACKGROUND

• 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.

  PMID: 8163974 BACKGROUND

• 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.

  PMID: 12925632 BACKGROUND

Study Officials

• Carlos Higuera, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Surgeon

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 26, 2017
• Study Start: December 1, 2016
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)