Clinical trial NCT05773261: Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups
Official title: Modern Surfaces of the Uncemented Cup in Total Hip Arthroplasty: A Randomized, Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups Using CT-based Micromotion Analysis and Clinical Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Keywords: Osteoarthritis
Total hip arthroplasty
Uncemented total hip arthroplasty
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
name: Region Västerbotten
First posted: 2023-03-17
Enrollment: 70
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control: Pinnacle Gription series 100 cup with a Marathon liner combined med with a Corail femoral stem.

Investigational device: MobilLINK TrabecuLINK cup with X-LINKed liner combined with a LCU femoral stem.
Primary purpose: TREATMENT

Brief summary: A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.

Detailed description: The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.

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.

Eligibility criteria: Inclusion Criteria:

* Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
* 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:

* Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
* 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

Primary outcomes:
measure: Early migration of the cup
timeFrame: 2 years after operation
Secondary outcomes:
measure: Proximal wear
timeFrame: 5 years after operation
measure: 3D wear
timeFrame: 5 years after operation
measure: Long term migratio
timeFrame: 15 years after operation
measure: Long term wear
timeFrame: 15 years after operation
measure: Stem migration
timeFrame: 15 years
measure: Patient reported outcome with Forgotten Joint Score
timeFrame: 15 years after operation
measure: Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score
timeFrame: 15 years after operation
measure: Patient reported outcome with University of California, Los Angeles Activity Score
timeFrame: 15 years after operation
measure: Patient reported outcome with EuroQuol 5.
timeFrame: 15 years after operation
measure: Reoperations
timeFrame: 15 years after operation
measure: Osteolysis
timeFrame: 15 years after operation
measure: Precision of migration measurements with CTMA
timeFrame: 1 year after operation
measure: Precision of wear mearurements with CTMA
timeFrame: 1 year after operation
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Volker Otten
state: Västerbotten
Study officials:
affiliation: Umeå University hospital/Umeå University
name: Volker Otten, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.