An interventional study of MobilLINK TrabecuLINK cup and Pinnacle Gription cup in Osteoarthritis, Hip, sponsored by Umeå University. Active, not recruiting at 1 site in Sweden. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-08.
Sponsored by Umeå University · Not applicable, Interventional, and Treatment
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.
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.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
This study's enrollment of 70 is below the median of 90 across 458 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →Umeå University is the lead sponsor of 271 studies on the registry; 60 are open to participants now.
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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 %.
Device: MobilLINK TrabecuLINK 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).
Device: Pinnacle Gription cup
THA with MobilLINK TrabecuLINK cup and LCU stem
THA with Pinnacle Gription cup and Coral stem
Early migration of the cup
Migration of the cup between 3 month and 2 years after implantation of the cup measured with Computed Tomography scan based Micromotion Analysis (CTMA) in mm.
Time frame: 2 years after operation
Proximal wear
Liner wear measured as proximal penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
Time frame: 5 years after operation
3D wear
Liner wear measured as 3D penetration of the femoral head prosthesis into the liner between 1 year and 5 years after operation in mm
Time frame: 5 years after operation
Long term migratio
Migration of the cup measured in mm with CTMA
Time frame: 15 years after operation
Long term wear
Liner wear measured in mm with CTMA
Time frame: 15 years after operation
Stem migration
Distal and 3D migration in mm of the stem between post- operative examination and 3 month, 3 month and 2 years, 3 month and 5 years and 3 month and 15 years.
Time frame: 15 years
Patient reported outcome with Forgotten Joint Score
Patient-reported outcome measured by Forgotten Joint Score (FSJ). The scores will be summarized and transformed to a scale ranging from 0 to 100, where a high value indicate that the patient tends to be less aware of the affected joint when performing daily activities.
Time frame: 15 years after operation
Patient reported outcome with Hip dysfunction and Osteoarthritis Outcome Score
Patient-reported outcome measured by Hip dysfunction and Osteoarthritis Outcome Score (HOOS). Each of the 5 subscales will get a score of 0 to 100, with 0 indicating extreme symptoms and 100 indicating no symptoms. The subscales will be plotted as a HOOS profile, by connecting the mean scores for all 5 dimensions with a line.
Time frame: 15 years after operation
Patient reported outcome with University of California, Los Angeles Activity Score
Patient-reported outcome measured by University of California, Los Angeles Activity Score (UCLA). The patients physical activity level rank from 1 (low) to 10 (high).
Time frame: 15 years after operation
Patient reported outcome with EuroQuol 5.
Patient reported health related quality of life, measured by EuroQuol 5 dimensions (EQ-5D). For the calculation of the EQ-5D index the standard value set version 2.1 for Sweden is used. Index scores range from 0 ( 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Time frame: 15 years after operation
Reoperations
Incidence and rate of revisions, re-operations and operation-related complications
Time frame: 15 years after operation
Osteolysis
Incidence and rate of patients showing osteolysis around the cup on CT scans and/or on x-rays
Time frame: 15 years after operation
Precision of migration measurements with CTMA
Precision of migration measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Time frame: 1 year after operation
Precision of wear mearurements with CTMA
Precision of wear measurement in mm with CTMA, by comparing double CT scans obtained on the same day at the 1 year follow-up.
Time frame: 1 year after operation
Plan to share: No
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