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RecruitingNCT06287021Updated Sep 2, 2025

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

An interventional study of Jump System Traser® cup and Jump System HAX-Pore® cup in Total Hip Arthroplasty, sponsored by Permedica spa. Recruiting at 2 sites in Italy. Open to participants aged 40 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Permedica spa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

In joint arthroplasty, the need to use devices with highly-porous structures even more close to cancellous bone, arises from the need of optimal implant primary stability and osseointegration to guarantee long term longevity of the prosthetic implant.

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.

02

Conditions studied

  • Total Hip Arthroplasty

Keywords

  • Bone Mineral Density
  • DEXA
  • Additive Manufacturing
  • 3D-Printing
  • Selective Laser Melting
  • Highly-Porous Titanium
03

In context

Lead sponsor

Permedica spa is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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;
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    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

    Device: Jump System Traser® cup

  • Active comparator
    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

    Device: Jump System HAX-Pore® cup

Interventions

  • DeviceJump System Traser® cup

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

  • DeviceJump System HAX-Pore® cup

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

06

What researchers measure

Primary outcomes

  1. BMD - ROI 1

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

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

Secondary outcomes

  1. BMD - ROI 2,3,4

    Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 2, 3 and 4 (behind and below the acetabular cup)

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

  2. Harris hip score

    Clinical score for hips undergoing total hip arthroplasty. The Harris hip score ranges from 0 to 100, where 100 indicates the best outcome possible for the patient.

    Time frame: Preoperative,12-month, and 24-month follow-up

  3. Moore's osseointegration signs

    Five radiographic signs around the acetabular cup revealing the stability and osseointegration status of cementless component: (1) absence of radiolucent lines; (2) presence of a superolateral buttress; (3) medial stress-shielding; (4) radial trabeculae; and (5) an inferomedial buttress. The presence of 3 to 5 signs visible on anterior-posterior radiograph of the hip indicates 97% probability of a well osseointegrated cup. The presence of 1 or no signs indicates 83% probability of unstable, not osseointegrated cup.

    Time frame: 12-month and 24-month follow-up

07

Study locations

2 of 2 sites recruiting
  • IRCCS Istituto Clinico San Siro
    Milan, 20148, Italy
    Recruiting
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio
    Milan, 20161, Italy
    Recruiting
08

References and documents

Publications

  • 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. PubMed 30994043 ↗
  • 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. PubMed 29589467 ↗
  • 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. PubMed 29400118 ↗
  • 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. PubMed 28734611 ↗
  • 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. PubMed 29742946 ↗
  • 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. PubMed 28708200 ↗
  • 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. PubMed 25338110 ↗
  • 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. PubMed 24500826 ↗
  • 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. PubMed 21768625 ↗
  • 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. PubMed 21434845 ↗
  • 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. PubMed 19473807 ↗
  • 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. PubMed 16761153 ↗
  • 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. PubMed 16752282 ↗
  • 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. PubMed 31965345 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06287021
Lead sponsor
Permedica spa
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Apr 9, 2024
Primary completion
Jun 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Sep 2, 2025

Study contacts

Lorenzo Banci, MSc
Contact
lorenzo.banci@permedica.it
+390399514811
Marta Colombo, MSc
Contact
marta.colombo@permedica.it
Lorenzo Banci, MSc
study director · Permedica Orthopaedics, Merate, Italy
Giuseppe Peretti, MD
principal investigator · IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy
Paolo Sirtori, MD
principal investigator · Istituto Clinico San Siro, Milan, Italy

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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