Total Hip ArthroplastyNCT06287021
Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
A study testing Jump System Traser® cup and Jump System HAX-Pore® cup in people with Total Hip Arthroplasty, run by Permedica spa at 2 sites in Italy.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Jump System Traser® cup and Jump System HAX-Pore® cup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Apr 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 15Show fewer
- 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;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marta Colombo, MSc contact
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto Clinico San Siro
Milan, 20148
Matteo Del Re, MD, matteodelre91@gmail.com
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, 20161
Ricardo Ciliberto, MD, rciliberto@gmail.com
Laura
About this study
Official title: Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
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.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Jump System Traser® cup, Jump System HAX-Pore® cup
- Keywords
- Bone Mineral Density, DEXA, Additive Manufacturing, 3D-Printing, Selective Laser Melting, Highly-Porous Titanium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jump System Traser® cupDevice
Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
Jump System HAX-Pore® cupDevice
Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Jump System HAX-Pore® cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD - ROI 1
Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 1 (above the acetabular cup)
Measured: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Secondary outcomes (3)
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)
Measured: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
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.
Measured: Preoperative,12-month, and 24-month follow-up
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.
Measured: 12-month and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start9 Apr 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled, randomized, unblinded, multicenter
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Permedica spa
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorenzo Banci, MSc, Study director, Permedica Orthopaedics, Merate, ItalyGiuseppe Peretti, MD, Principal investigator, IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, ItalyPaolo Sirtori, MD, Principal investigator, Istituto Clinico San Siro, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287021
- Sponsor's protocol ID
- TRASERBMD2022
- Status last verified
- Aug 2025
- First submitted
- 9 Feb 2024
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 30994043Paxton 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 29589467Laaksonen 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 29400118Macheras 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 28734611Bondarenko 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 29742946Massari 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 28708200Salemyr 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 25338110Lazarinis 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 24500826Periasamy 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 21768625Baad-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 21434845Meneghini 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 19473807Laursen 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 16761153Digas 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 16752282Ragone 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06287021
- Acronym / sponsor ID
- TRASERBMD2022
- Conditions
- Total Hip Arthroplasty
- Keywords
- Bone Mineral Density, DEXA, Additive Manufacturing, 3D-Printing, Selective Laser Melting, Highly-Porous Titanium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Permedica spaIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled, randomized, unblinded, multicenter
| Arm | Type | Receives |
|---|---|---|
| Jump System Traser® cup | Experimental | Device: Jump System Traser® cup25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup |
| Jump System HAX-Pore® cup | Active comparator | Device: Jump System HAX-Pore® cup25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite/titanium plasma-sprayed cup |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jump System Traser® cupPress-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup | Device | Jump System Traser® cup |
| Jump System HAX-Pore® cupPress-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup | Device | Jump System HAX-Pore® cup |
Primary outcome
BMD - ROI 1
Time frame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Periprosthetic BMD (bone mineral density) measured by DEXA in ROI (region of interest) 1 (above the acetabular cup)
3 secondary outcomes
BMD - ROI 2,3,4
Time frame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Harris hip score
Time frame: Preoperative,12-month, and 24-month follow-up
Moore's osseointegration signs
Time frame: 12-month and 24-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 30994043Hemmila 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.
- Background: PubMed 29589467Paxton 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.
- Background: PubMed 29400118Laaksonen 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.
- Background: PubMed 28734611Macheras 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.
- Background: PubMed 29742946Bondarenko 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.
- Background: PubMed 28708200Massari 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.
- Background: PubMed 25338110Salemyr 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.
- Background: PubMed 24500826Lazarinis 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.
- Background: PubMed 21768625Periasamy 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.
- Background: PubMed 21434845Baad-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.
- Background: PubMed 19473807Meneghini 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.
- Background: PubMed 16761153Laursen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Colombo, MSc contact
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jump System Traser® cup and Jump System HAX-Pore® cup in people with Total Hip Arthroplasty, run by Permedica spa at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lorenzo Banci, MSc (+390399514811, lorenzo.banci@permedica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD - ROI 1 (time frame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287021, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.