Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

In this prospective multicenter study, a population of adult individuals consecutively treated for revision hips, requiring a custom-made acetabular implant for non-oncological reasons, will be included. The custom-made implant is a personalized implant produced using additive manufacturing, based on the pre-operative CT scan that details the bone damage. Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls).

Preoperatively, the patient will undergo a clinical evaluation. Data will be collected on the patient's general health status with the Charlson score, the reason for revision, number of revisions, type of implant in place, and the time elapsed between the failed implant and the revision in question. The bone deficit will be studied through CT measurements according to qualitative and quantitative scales. During the surgery, information on intraoperative complications will be collected. In the postoperative period, perioperative complications will be collected according to the Clavien Dindo classification. The clinical radiographic evaluations will be carried out during outpatient follow-up visits at 1, 3, 12, 24, and 36 months after revision. They include the Harris Hip Score clinical score, the EQ-5D PROM, and the patient's satisfaction level (qualitative assessment in 4 grades: unsatisfied, slightly satisfied, moderately satisfied, fully satisfied). The positional parameters of the implant will be evaluated, as compared to the immediate post-operative X-ray: acetabular abduction, acetabular anteversion, center of rotation height, center of rotation medialization, and inclination of the custom-made component. From 12 months onwards, the osteointegration characteristics of the component will be assessed: presence of radial trabeculae at the interface, superolateral and inferior reinforcements, stress shielding, absence of radiolucent lines. Re-revision rates will be determined using the Kaplan-Meier method. The reasons for re-revision will be noted.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

need of custom-made acetabular implant on the basis of CT and X-ray evaluation ()

pre-operative CT scan

adults patients (minimum age: 18 years)

complete medical charts

Disqualifiers

oncological reasons for revision

other types of revision implant (non custom)

inadequate medical chart

lack of pre-operative CT scan

Trial population

The study population will consist of adult individuals (minimum age: 18 years) consecutively treated for revision hips (non-oncological reasons) requiring a custom-made acetabular implant. Patients will be enrolled in 4 tertiary centers (multicenter prospective study). Patients eligible for this implant are those with severe acetabular bone damage Paprosky 3 (loss of the superolateral part and one of the two ventro-caudal walls).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • custom-made acetabular implant

    Device

    custom-made acetabular implant produced with additive manufacturing, to fill the bony loss in Paprosky III bone defects

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Custom-made1 intervention

Trial outcomes

Primary outcomes

1

Perioperative complications

Clavien-Dindo classification: 5 stages with IIIA and IIIB, IV A and IV B. I stage: minimal complications, V stage: death of the patient.

Time frame
0-30 days
2

Objective clinical outcomes

Harris Hip Score. Numerical scale assessing mobility, pain and functionality. Range: 0-100. 100 is the best objective outcome.

Time frame
0-18 months
3

Subjective clinical outcomes

EQ-5D-5L. Subjective score with 5 dimensions: mobility, self-care, pain, usual activity, anxiety/depression (5 levels per each assessment). Weighted index on a 0-1 scale. Best outcome: 1

Time frame
0-18 months
4

Subjective clinical outcomes (satisfaction)

Percentage of satisfied patients per single level. 4 levels, from not satisfied to completely satisfied.

Time frame
0-18 months

Secondary outcomes

1

Osseointegration of the acetabular component

Percentages of cases with good osseointegration of the acetabular component according to Moore's criteria. At least three criteria among: presence of radial trabeculae at the interface, presence of superolateral buttress, presence of inferior buttress, presence of medial stress shielding, absence of radiolucent lines. Range: 0-100%. Best outcome: 100%

Time frame
12-18 months

Other outcomes

Sponsors and contacts

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