Innovative Technologies for Salvage Procedures of Failed Treatments of Osteoarthritis: Biomimetics Solutions (CustomPN)
NCT Number: NCT06527664
Acronym: CustomPN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Bone Loss|Hip Prosthesis Infection|Arthroplasty Complications
Interventions: DEVICE: custom-made acetabular implant
Sponsor: Istituto Ortopedico Rizzoli
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-30
Completion Date: 2026-09-30
Locations: Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy, Bologna, 40136, Italy

Summary:
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.

Primary Outcome Measures: 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., 0-30 days|Objective clinical outcomes, Harris Hip Score. Numerical scale assessing mobility, pain and functionality. Range: 0-100. 100 is the best objective outcome., 0-18 months|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, 0-18 months|Subjective clinical outcomes (satisfaction), Percentage of satisfied patients per single level. 4 levels, from not satisfied to completely satisfied., 0-18 months|Survival rates, Survival rates using Kaplan Meier curve. Range: 0-100%. Best outcome: 100%, 0-18 months
Secondary Outcome Measures: 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%, 12-18 months