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Closed the single investigator initiated study at request of Stryker, to begin collecting as a multicenter study.
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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.
Data will be collected preoperatively, and at the standard of care (SOC) office visits at 4 weeks, 1 year, 2 years, 5 years and 10 years postoperatively. The research coordinator at each site will identify, recruit, and prospectively follow the 60 patients at his/her site. Patient demographics (e.g., age, gender, body mass index (BMI)), comorbidities, reason for revision, Paprosky classification, native femoral head measurement (mm) etc. will be collected preoperatively. The study coordinator will contact patients prior to each visit to ensure patient compliance. At each visit, A-P and cross-lateral radiographic evaluation (i.e., use of Engh classification to quantify osteolysis/loosening) will occur. In addition, patients will be assessed for any complications (e.g., dislocation, emergency department visits, infection, reoperation, etc.). Patients will complete the Hip disability and Osteoarthritis Outcome Score (HOOS) and Veterans Rand 12 (VR-12) forms (including a specific question regarding groin pain) and a pain assessment. In the event that a patient has relocated and/or refuses to return to the office for the 5-year visit, a script will be sent to the patient to have x-rays done and sent to the PI, and questionnaires will be mailed. All data will be entered and maintained in RedCap.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| revision multihole acetabular cup | Revision total hip arthroplasty using multihole revision acetabular cup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| revision multihole acetabular cup | Device | post market study of multi hole revision acetabular cup |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcomes of multihole revision acetabular cup | determine clinical outcomes with VR-12 surveys | 10 years |
| functional outcomes of multihole revision acetabular cup | determine functional outcomes with HOOS surveys |
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Inclusion Criteria:
Exclusion Criteria:
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Patients requiring a revision total hip arthroplasty
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Higuera, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19809857 | Background | 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. | |
| 22717834 | 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. |
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| 10 years |
| assess pain levels in patients who receive multihole revision acetabular cup | determine level of pain with pain assessments | 10 years |
| 16376255 | 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. |
| 23927907 | 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. |
| 17403800 | 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. |
| 7554631 | 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. |
| 10790649 | 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. |
| 19023943 | 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. |
| 19876878 | 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. |
| 15389510 | 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. |
| 8163974 | 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. |
| 12925632 | 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. |