Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

Osteoarthritis, Hip Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05773261
• Other study ID #: TrabecuLINK study
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: September 9, 2039

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: September 9, 2039
• Est. primary completion date: September 9, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• MobilLINK TrabecuLINK cup
THA with MobilLINK TrabecuLINK cup and LCU stem
• Pinnacle Gription cup
THA with Pinnacle Gription cup and Coral stem

Locations

Country	Name	City	State
Sweden	Volker Otten	Umeå	Västerbotten

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Region Västerbotten, University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

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. — View 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. Erratum In: Bone Joint J. 2018 Sep;100-B(9):1260. Bone Joint J. 2018 Sep;100-B(9):1260. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years after operation
Secondary	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	5 years after operation
Secondary	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	5 years after operation
Secondary	Long term migratio	Migration of the cup measured in mm with CTMA	15 years after operation
Secondary	Long term wear	Liner wear measured in mm with CTMA	15 years after operation
Secondary	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.	15 years
Secondary	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.	15 years after operation
Secondary	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.	15 years after operation
Secondary	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).	15 years after operation
Secondary	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.	15 years after operation
Secondary	Reoperations	Incidence and rate of revisions, re-operations and operation-related complications	15 years after operation
Secondary	Osteolysis	Incidence and rate of patients showing osteolysis around the cup on CT scans and/or on x-rays	15 years after operation
Secondary	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.	1 year after operation
Secondary	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.	1 year after operation