Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
NCT ID: NCT06287021
Last Updated: 2025-09-02
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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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-09
2028-06-30
Brief Summary
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Detailed Description
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After decades of clinical use of highly-porous tantalum (Trabecular Metal) acetabular components in total hip arthroplasty with excellent results, new highly-porous titanium structures have been developed and introduced in the market thanks to the additive manufacturing technology.
This study aims to investigate how bone remodeling occurs after primary total hip arthroplasty around a highly-porous trabecular-irregular acetabular cup, 3D-printed with selective laser melting, in comparison with a standard hydroxyapatite/titanium plasma-sprayed cup with the same design. The null hypothesis, which the study aims to reject, is that there is no difference in bone mineral density changes between highly-porous and traditional plasma-sprayed cups.
Overall 50 patients will be enrolled to be 1:1 randomized for receiving the investigational cup or the control cup in two centers.
Periprosthetic bone mineral density will be measured by DEXA (Dual-Energy X-ray Absorptiometry) around the acetabular cup according to four ROI (Region Of Interest). DEXA scans will be taken at different time-points up to 2-year follow-up. DEXA scan taken before patient discharge will be used as baseline.
Patients will be assessed also for clinical and radiological results, with focus on osseointegration signs of the acetabular cup.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Jump System Traser® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup
Jump System Traser® cup
Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
Jump System HAX-Pore® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite/titanium plasma-sprayed cup
Jump System HAX-Pore® cup
Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup
Interventions
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Jump System Traser® cup
Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
Jump System HAX-Pore® cup
Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup
Eligibility Criteria
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Inclusion Criteria
* Patient with primary or secondary hip osteoarthritis;
* Patient who has given informed consent;
Exclusion Criteria
* Female patients younger than 50 years or older than 85 years;
* Childbearing;
* Patients not indicated for receiving the investigational devices;
* Patients not indicated for receiving cementless metaphyseal short femoral stems by Permedica Orthopaedics as the "Exacta RS" or "Exacta S" brand;
* Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (grade III-IV according to Crowe classification), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture or sequelae of previous surgical procedures or trauma to the ipsilateral hip;
* Patients with bone disorders;
* Patients with diabetes;
* Patients under PTH (parathyroid hormone), corticosteroid, or osteoporosis pharmacological therapy;
* Patients with disabling disease in the contralateral limb;
* Patients with BMI \> 30 or \< 18;
* Patients not willing to follow the study protocol;
* Patients incapable to understand the study protocol;
* Patients addicted to alcohol or drugs;
* Patients already enrolled in other clinical investigations;
40 Years
85 Years
ALL
Yes
Sponsors
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Permedica spa
INDUSTRY
Responsible Party
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Principal Investigators
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Lorenzo Banci, MSc
Role: STUDY_DIRECTOR
Permedica Orthopaedics, Merate, Italy
Giuseppe Peretti, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy
Paolo Sirtori, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Clinico San Siro, Milan, Italy
Locations
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IRCCS Istituto Clinico San Siro
Milan, , Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Laura
Role: backup
References
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Hemmila M, Karvonen M, Laaksonen I, Matilainen M, Eskelinen A, Haapakoski J, Puhto AP, Kettunen J, Manninen M, Makela KT. Survival of 11,390 Continuum cups in primary total hip arthroplasty based on data from the Finnish Arthroplasty Register. Acta Orthop. 2019 Aug;90(4):312-317. doi: 10.1080/17453674.2019.1603596. Epub 2019 Apr 17.
Paxton EW, Mohaddes M, Laaksonen I, Lorimer M, Graves SE, Malchau H, Namba RS, Karrholm J, Rolfson O, Cafri G. Meta-analysis of individual registry results enhances international registry collaboration. Acta Orthop. 2018 Aug;89(4):369-373. doi: 10.1080/17453674.2018.1454383. Epub 2018 Mar 28.
Laaksonen I, Lorimer M, Gromov K, Eskelinen A, Rolfson O, Graves SE, Malchau H, Mohaddes M. Trabecular metal acetabular components in primary total hip arthroplasty. Acta Orthop. 2018 Jun;89(3):259-264. doi: 10.1080/17453674.2018.1431445. Epub 2018 Feb 5.
Macheras GA, Lepetsos P, Leonidou AO, Anastasopoulos PP, Galanakos SP, Poultsides LA. Survivorship of a Porous Tantalum Monoblock Acetabular Component in Primary Hip Arthroplasty With a Mean Follow-Up of 18 Years. J Arthroplasty. 2017 Dec;32(12):3680-3684. doi: 10.1016/j.arth.2017.06.049. Epub 2017 Jul 6.
Bondarenko S, Dedukh N, Filipenko V, Akonjom M, Badnaoui AA, Schwarzkopf R. Comparative analysis of osseointegration in various types of acetabular implant materials. Hip Int. 2018 Nov;28(6):622-628. doi: 10.1177/1120700018759314. Epub 2018 May 9.
Massari L, Bistolfi A, Grillo PP, Borre A, Gigliofiorito G, Pari C, Francescotto A, Tosco P, Deledda D, Ravera L, Causero A. Periacetabular bone densitometry after total hip arthroplasty with highly porous titanium cups: a 2-year follow-up prospective study. Hip Int. 2017 Nov 21;27(6):551-557. doi: 10.5301/hipint.5000509. Epub 2017 Jul 1.
Salemyr M, Muren O, Eisler T, Boden H, Chammout G, Stark A, Skoldenberg O. Porous titanium construct cup compared to porous coated titanium cup in total hip arthroplasty. A randomised controlled trial. Int Orthop. 2015 May;39(5):823-32. doi: 10.1007/s00264-014-2571-z. Epub 2014 Oct 22.
Lazarinis S, Milbrink J, Mattsson P, Mallmin H, Hailer NP. Bone loss around a stable, partly threaded hydroxyapatite-coated cup: a prospective cohort study using RSA and DXA. Hip Int. 2014 Mar-Apr;24(2):155-66. doi: 10.5301/hipint.5000104. Epub 2014 Feb 3.
Periasamy K, Watson WS, Mohammed A, Murray H, Walker B, Patil S, Meek RM. A randomised study of peri-prosthetic bone density after cemented versus trabecular fixation of a polyethylene acetabular component. J Bone Joint Surg Br. 2011 Aug;93(8):1033-44. doi: 10.1302/0301-620X.93B8.26233.
Baad-Hansen T, Kold S, Nielsen PT, Laursen MB, Christensen PH, Soballe K. Comparison of trabecular metal cups and titanium fiber-mesh cups in primary hip arthroplasty: a randomized RSA and bone mineral densitometry study of 50 hips. Acta Orthop. 2011 Apr;82(2):155-60. doi: 10.3109/17453674.2011.572251. Epub 2011 Mar 25.
Meneghini RM, Ford KS, McCollough CH, Hanssen AD, Lewallen DG. Bone remodeling around porous metal cementless acetabular components. J Arthroplasty. 2010 Aug;25(5):741-7. doi: 10.1016/j.arth.2009.04.025. Epub 2009 May 26.
Laursen MB, Nielsen PT, Soballe K. Bone remodelling around HA-coated acetabular cups : a DEXA study with a 3-year follow-up in a randomised trial. Int Orthop. 2007 Apr;31(2):199-204. doi: 10.1007/s00264-006-0148-1. Epub 2006 Jun 8.
Digas G, Karrholm J, Thanner J. Different loss of BMD using uncemented press-fit and whole polyethylene cups fixed with cement: repeated DXA studies in 96 hips randomized to 3 types of fixation. Acta Orthop. 2006 Apr;77(2):218-26. doi: 10.1080/17453670610045948.
Ragone V, Canciani E, Arosio M, Olimpo M, Piras LA, von Degerfeld MM, Augusti D, D'Ambrosi R, Dellavia C. In vivo osseointegration of a randomized trabecular titanium structure obtained by an additive manufacturing technique. J Mater Sci Mater Med. 2020 Jan 21;31(2):17. doi: 10.1007/s10856-019-6357-0.
Other Identifiers
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TRASERBMD2022
Identifier Type: -
Identifier Source: org_study_id
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