Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
NCT ID: NCT05773261
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
70 participants
INTERVENTIONAL
2022-09-09
2039-09-09
Brief Summary
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Detailed Description
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Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.
In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Investigational device: MobilLINK TrabecuLINK cup with X-LINKed liner combined with a LCU femoral stem.
TREATMENT
NONE
Study Groups
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MobilLINK TrabecuLINK cup
The investigational device in this study is the newly developed MobilLINK TrabecuLINK cup. It will in this study be combined with a uncemented LCU stem.
The MobilLINK TrabecuLINK cups are made from Tilastan, a Ti6A4V alloy. The MobileLINK press-fit shells are hemispheric and polar flattened. An equatorial press-fit is built into the shells for primary stability after cementless implantation. All shells have a polar hole, which is used to connect an impactor handle for implantation of the shell. This polar hole can be closed with a polar screw. The MobileLINK TrabecuLINK shells have a 3D printed trabecular surface structure with a pore size of 610 to 820 μm and a porosity of 70 %.
MobilLINK TrabecuLINK cup
THA with MobilLINK TrabecuLINK cup and LCU stem
Pinnacle Gription Series 100 cup
For the control group a Pinnacle Gription cup series 100 with a apex hole eliminator will be used together with a neutral cross-linked polyethylene (XLPE) Marathon liner (DePuy Synthes by Johnson \& Johnson, Norderstedt, Germany). The Pinnacle Gription cup is a hemispherical, single-geometry, titanium press-fit cup with a solid body. The outer surface consists of a porous coating with 300 μm sintered titanium beads coated with an extra layer of irregularly shaped pure titanium pieces. In cases where no initial stability can be reached when using the Pinnacle 100 series, the Pinnacle Gription sector cup with additional bone screws will be used. The cross-linked Marathon insert is made of 1050 GUR resin, irradiated with 50 kGy, remelted and plasma sterilized.
The Pinnacle Gription cup will be implanted together with a Corail stem (DePuy Synthes).
Pinnacle Gription cup
THA with Pinnacle Gription cup and Coral stem
Interventions
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MobilLINK TrabecuLINK cup
THA with MobilLINK TrabecuLINK cup and LCU stem
Pinnacle Gription cup
THA with Pinnacle Gription cup and Coral stem
Eligibility Criteria
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Inclusion Criteria
* Age 30-70 years
* Primary osteoarthritis of the hip
* Body Mass Index between 18 and 35 kg/m2
* Willingness and ability to follow clinical investigation protocol
Exclusion Criteria
* Osteoporosis
* Paget's disease
* Inflammatory arthritis
* Secondary osteoarthritis
* Presence of malignancy in the area of surgery
* Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
* Previous surgery in the affected hip
* Inclusion of the contralateral hip in this clinical investigation
* Not suited for the clinical investigation for other reason (surgeon's judgment)
* Pregnant or breastfeeding women
* Prison inmate
30 Years
70 Years
ALL
No
Sponsors
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University Hospital, Umeå
OTHER
Region Västerbotten
OTHER_GOV
Umeå University
OTHER
Responsible Party
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Principal Investigators
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Volker Otten, M.D, PhD
Role: PRINCIPAL_INVESTIGATOR
Umeå University hospital/Umeå University
Locations
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Volker Otten
Umeå, Västerbotten County, Sweden
Countries
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References
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Buttaro MA, Onativia JI, Slullitel PA, Andreoli M, Comba F, Zanotti G, Piccaluga F. Metaphyseal debonding of the Corail collarless cementless stem: report of 18 cases and case-control study. Bone Joint J. 2017 Nov;99-B(11):1435-1441. doi: 10.1302/0301-620X.99B11.BJJ-2017-0431.R1.
Louboutin L, Viste A, Desmarchelier R, Fessy MH. Long-term survivorship of the Corail standard stem. Orthop Traumatol Surg Res. 2017 Nov;103(7):987-992. doi: 10.1016/j.otsr.2017.06.010. Epub 2017 Aug 1.
van der Voort P, Pijls BG, Nieuwenhuijse MJ, Jasper J, Fiocco M, Plevier JW, Middeldorp S, Valstar ER, Nelissen RG. Early subsidence of shape-closed hip arthroplasty stems is associated with late revision. A systematic review and meta-analysis of 24 RSA studies and 56 survival studies. Acta Orthop. 2015;86(5):575-85. doi: 10.3109/17453674.2015.1043832.
Bitsch RG, Loidolt T, Heisel C, Ball S, Schmalzried TP. Reduction of osteolysis with use of Marathon cross-linked polyethylene. A concise follow-up, at a minimum of five years, of a previous report. J Bone Joint Surg Am. 2008 Jul;90(7):1487-91. doi: 10.2106/JBJS.F.00991.
Campbell D, Mercer G, Nilsson KG, Wells V, Field JR, Callary SA. Early migration characteristics of a hydroxyapatite-coated femoral stem: an RSA study. Int Orthop. 2011 Apr;35(4):483-8. doi: 10.1007/s00264-009-0913-z. Epub 2009 Dec 13.
Goriainov V, Jones A, Briscoe A, New A, Dunlop D. Do the cup surface properties influence the initial stability? J Arthroplasty. 2014 Apr;29(4):757-62. doi: 10.1016/j.arth.2013.07.007. Epub 2013 Nov 22.
Drobniewski M, Borowski A, Synder M, Sibinski M. Results of total cementless hip joint arthroplasty with Corail stem. Ortop Traumatol Rehabil. 2013 Jan-Feb;15(1):61-8. doi: 10.5604/15093492.1032797.
Other Identifiers
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TrabecuLINK study
Identifier Type: -
Identifier Source: org_study_id