Clinical trial NCT06287021: Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Official title: Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: Bone Mineral Density
DEXA
Additive Manufacturing
3D-Printing
Selective Laser Melting
Highly-Porous Titanium
Lead sponsor: Permedica spa
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled, randomized, unblinded, multicenter
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

* 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;

Primary outcomes:
measure: BMD - ROI 1
timeFrame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
Secondary outcomes:
measure: BMD - ROI 2,3,4
timeFrame: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up
measure: Harris hip score
timeFrame: Preoperative,12-month, and 24-month follow-up
measure: Moore's osseointegration signs
timeFrame: 12-month and 24-month follow-up
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Clinico San Siro
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
affiliation: Permedica Orthopaedics, Merate, Italy
name: Lorenzo Banci, MSc
role: STUDY_DIRECTOR
affiliation: IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy
name: Giuseppe Peretti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico San Siro, Milan, Italy
name: Paolo Sirtori, MD
role: PRINCIPAL_INVESTIGATOR
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