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

NCT05773261 | Active Not Recruiting DMC

• 1 other identifier: TrabecuLINK study
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Hip

Keywords

Osteoarthritis; Total hip arthroplasty; Uncemented total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Proximal wear

  5 years after operation

• 3D wear

  5 years after operation

• Long term migratio

  15 years after operation

• Long term wear

  15 years after operation

• Stem migration

  15 years

Study Arms (2)

MobilLINK TrabecuLINK cup

ACTIVE COMPARATOR

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

Pinnacle Gription Series 100 cup

ACTIVE COMPARATOR

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

Interventions

MobilLINK TrabecuLINK cup DEVICE

THA with MobilLINK TrabecuLINK cup and LCU stem

MobilLINK TrabecuLINK cup

Pinnacle Gription cup DEVICE

THA with Pinnacle Gription cup and Coral stem

Pinnacle Gription Series 100 cup

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Not suited for the clinical investigation for other reason (surgeon's judgment)
• Pregnant or breastfeeding women
• Prison inmate

Sponsors & Collaborators

• Umeå University: lead
• University Hospital, Umeå: collaborator
• Region Västerbotten: collaborator

Study Sites (1)

Volker Otten

Umeå, Västerbotten County, 907 37, Sweden

Location

Related Publications (7)

• 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.

  PMID: 29092981 BACKGROUND

• 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.

  PMID: 28778624 BACKGROUND

• 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.

  PMID: 25909455 BACKGROUND

• 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.

  PMID: 18594097 BACKGROUND

• 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.

  PMID: 20012862 BACKGROUND

• 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.

  PMID: 24269067 BACKGROUND

• 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.

  PMID: 23510822 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Volker Otten, M.D, PhD

  Umeå University hospital/Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: March 17, 2023
• Study Start: September 9, 2022
• Primary Completion (Estimated): September 9, 2026
• Study Completion (Estimated): September 9, 2039
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)