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

NCT06527664 | Recruiting DMC

• 1 other identifier: 344/2024/Oss/IOR
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss; Hip Prosthesis Infection; Arthroplasty Complications

Keywords

revision hip arthroplasty; custom-made implant; additive manufacturing

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Osseointegration of the acetabular component

  12-18 months

Study Arms (1)

Custom-made

Revision hip arthroplasty performed for non-oncological reasons, with Paprosky III bone loss

Device: custom-made acetabular implant

Interventions

custom-made acetabular implant DEVICE

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

Custom-made

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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
• patients' availability

You may not qualify if:

• oncological reasons for revision
• other types of revision implant (non custom)
• inadequate medical chart
• lack of pre-operative CT scan

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Chirurgia Protesica e dei Reimpianti di Anca e Ginocchio, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Bologna, 40136, Italy

RECRUITING

Related Publications (6)

• Romagnoli M, Zaffagnini M, Carillo E, Raggi F, Casali M, Leardini A, Marcheggiani Muccioli GM, Grassi A, Zaffagnini S. Custom-made implants for massive acetabular bone loss: accuracy with CT assessment. J Orthop Surg Res. 2023 Sep 30;18(1):742. doi: 10.1186/s13018-023-04230-5.

  PMID: 37777776 RESULT

• Pandey AK, Zuke WA, Surace P, Kamath AF. Management of acetabular bone loss in revision total hip replacement: a narrative literature review. Ann Jt. 2023 Oct 5;9:21. doi: 10.21037/aoj-23-23. eCollection 2024.

  PMID: 38694811 RESULT

• Jones SA, Parker J, Horner M. Can a reconstruction algorithm in major acetabular bone loss be successful in revision hip arthroplasty? Bone Joint J. 2024 May 1;106-B(5 Supple B):47-53. doi: 10.1302/0301-620X.106B5.BJJ-2023-0809.R1.

  PMID: 38688489 RESULT

• Kim K, Sandiford NA. The Role of Three-Dimensional Custom Printing in Revision Total Hip Arthroplasty. Surg Technol Int. 2023 Sep 15;42:369-373. doi: 10.52198/23.STI.42.OS1698.

  PMID: 37675989 RESULT

• Pardo F, Bordini B, Castagnini F, Giardina F, Faldini C, Traina F. Are powder-technology-built stems safe? A midterm follow-up registry study. J Mater Sci Mater Med. 2021 Jan 20;32(1):10. doi: 10.1007/s10856-020-06481-8.

  PMID: 33471238 RESULT

• Castagnini F, Mariotti F, Tassinari E, Bordini B, Zuccheri F, Traina F. lsolated acetabular revisions of articular surface replacement (ASR) XL implants with highly porous titanium cups and Delta bearings. Hip Int. 2021 Mar;31(2):250-257. doi: 10.1177/1120700019874442. Epub 2019 Sep 4.

  PMID: 31480877 RESULT

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Francesco Traina, Prof

  IRCCS Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Castagnini, MD

CONTACT

+390516366418; francescocastagnini@hotmail.it

Francesco Traina, Prof

CONTACT

francesco.traina@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 30, 2024
• Study Start: October 1, 2024
• Primary Completion: March 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)