Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

NCT06287021 | Recruiting DMC

• 1 other identifier: TRASERBMD2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up.

Conditions

Total Hip Arthroplasty

Keywords

Bone Mineral Density; DEXA; Additive Manufacturing; 3D-Printing; Selective Laser Melting; Highly-Porous Titanium

Outcome Measures

Primary Outcomes (1)

• BMD - ROI 1

  Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 1 (above the acetabular cup)

  Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up

Secondary Outcomes (3)

• BMD - ROI 2,3,4

  Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up

• Harris hip score

  Preoperative,12-month, and 24-month follow-up

• Moore's osseointegration signs

  12-month and 24-month follow-up

Study Arms (2)

Jump System Traser® cup

EXPERIMENTAL

25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup

Device: Jump System Traser® cup

Jump System HAX-Pore® cup

ACTIVE COMPARATOR

25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite/titanium plasma-sprayed cup

Device: Jump System HAX-Pore® cup

Interventions

Jump System Traser® cup DEVICE

Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup

Jump System Traser® cup

Jump System HAX-Pore® cup DEVICE

Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup

Jump System HAX-Pore® cup

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by Permedica Orthopaedics (study sponsor).
• Patient with primary or secondary hip osteoarthritis;
• Patient who has given informed consent;

You may not qualify if:

• Male patients younger than 40 years or older than 85 years;
• 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;

Sponsors & Collaborators

• Permedica spa: lead

Study Sites (2)

IRCCS Istituto Clinico San Siro

Milan, 20148, Italy

RECRUITING

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, 20161, Italy

RECRUITING

Related Publications (14)

• 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.

  PMID: 30994043 BACKGROUND

• 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.

  PMID: 29589467 BACKGROUND

• 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.

  PMID: 29400118 BACKGROUND

• 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.

  PMID: 28734611 BACKGROUND

• 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.

  PMID: 29742946 BACKGROUND

• 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.

  PMID: 28708200 BACKGROUND

• 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.

  PMID: 25338110 BACKGROUND

• 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.

  PMID: 24500826 BACKGROUND

• 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.

  PMID: 21768625 BACKGROUND

• 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.

  PMID: 21434845 BACKGROUND

• 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.

  PMID: 19473807 BACKGROUND

• 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.

  PMID: 16761153 BACKGROUND

• 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.

  PMID: 16752282 BACKGROUND

• 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.

  PMID: 31965345 BACKGROUND

Study Officials

• Lorenzo Banci, MSc

  Permedica Orthopaedics, Merate, Italy

  STUDY DIRECTOR

• Giuseppe Peretti, MD

  IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy

  PRINCIPAL INVESTIGATOR

• Paolo Sirtori, MD

  Istituto Clinico San Siro, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Banci, MSc

CONTACT

+390399514811; lorenzo.banci@permedica.it

Marta Colombo, MSc

CONTACT

marta.colombo@permedica.it

Study Design

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

Model Details: Controlled, randomized, unblinded, multicenter

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 29, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)