Public Procurement and Clinical Outcomes

Following the presentation of clinical outcomes related to public procurement between 2014 and 2016 at the HALMED conference “New Legislation – A New Direction for Medical Devices” by a representative of Johnson & Johnson, which indirectly associated the Instrumentaria hip endoprosthesis with a significant increase in revision surgeries during the public procurement period, Instrumentaria is obliged to present the results of clinical safety and performance evaluations of its hip endoprosthesis.

In accordance with Annex X of Council Directive 93/42/EEC on medical devices and the European Commission’s MEDDEV 2.12/2 rev2 guidelines “Post-Market Clinical Follow-up Studies – Guidance for Manufacturers and Notified Bodies”, Instrumentaria, in collaboration with Merkur University Hospital and Prof. Dr. Sc. Šebečić as principal investigator, has been conducting a prospective, randomized clinical follow-up study of patients implanted with the THA system since 2011.

According to the study protocol 11-III-PMCF-01-THA, interim reports by the principal investigator are submitted upon request of the study sponsor, while a detailed analysis is conducted after an average 5-year follow-up period.
As per the latest interim report, 124 patients with an average age of 62 years have been included in the study, with arthritis being the primary indication in most cases. Apart from a few common postoperative complications (respiratory, infections), no issues related to the safety or performance of the system were observed. To date, no revisions have been recorded, resulting in a 100% implant survival rate.

After the Instrumentaria THA system met all requirements for inclusion in the national public procurement tender, the clinical monitoring was expanded to two reference institutions for musculoskeletal surgery:

• Clinic for Orthopaedic Surgery, University Hospital Centre Zagreb and University of Zagreb School of Medicine
• Clinic for Orthopaedics in Lovran

According to the defined protocol, principal investigators Prof. Dr. Sc. Domagoj Delimar, Dr. Alan Mahnik, Dr. Tomislav Prpić, and Dr. Joško Jeličić analyzed the clinical outcomes of 300 randomized patients over a defined period.

Immediate postoperative results demonstrated that the system was stable, with no complications directly related to the implant. Only one revision was performed due to an acute postoperative infection.

The clinical safety and effectiveness of the first generation of the generic Instrumentaria THA system clearly demonstrate the justification for its use in hip arthroplasty. Comparative analysis of clinical data from other THA systems confirmed that Instrumentaria’s system performs on par with substantially equivalent components from other manufacturers in terms of safety and effectiveness.

In response to public associations made at the level of the Agency for Medicinal Products and Medical Devices (HALMED) linking an increase in revision procedures to the Instrumentaria hip endoprosthesis, Instrumentaria conducted a detailed investigation in the institutions with the highest recorded revision rates.

The results clearly and unequivocally demonstrate that the increase in revision surgeries has no connection to the Instrumentaria hip implant. For example:

• The Clinic for Orthopaedics in Lovran, with 2,624 implanted hip endoprostheses, reported zero revisions, except for early revisions mostly related to perioperative complications.
• The Clinic for Orthopaedics, University of Zagreb School of Medicine, recorded only 4 revisions out of 999 implanted Instrumentaria hip prostheses. These cases will be further investigated to determine the exact cause of the revisions.

Clinical outcomes of the Instrumentaria hip endoprosthesis over the past six years have been extremely positive, indicating excellent initial fixation of the system. The osteoconductive properties of the prosthesis have demonstrated outstanding clinical results in terms of bone ingrowth into the microporous components.

Immediate clinical outcomes of the Instrumentaria THA system, as part of the national procurement program, have been satisfactory, suggesting a promising long-term survival rate of the prosthesis.

Short-term results are highly encouraging, and the safety and effectiveness of the cementless Instrumentaria THA system are clinically acceptable.
There were no clinical indicators of product defects or significant errors in use.

The Instrumentaria THA system can be regarded as a high-quality product, delivering reliable outcomes, even in the hands of less experienced surgeons.