GMK Sphere TiNb Total Knee Arthroplasty PMS Study

Total Knee Arthroplasty Clinical Trial

Official title:

A Monocentric, Prospective Clinical Survey on Long Term Performance of GMK Sphere Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801654
• Other study ID #: P.02.01.427
• Status: Recruiting
• Start date: February 5, 2020
• Est. completion date: December 5, 2033

Study information

• Verified date: April 2024
• Source: Medacta International SA
• Contact: Franco Parente, Dr
• Phone: +390248785210
• Email: franco.parente[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Total knee arthroplasty (TKA) is one of the success stories of modern surgery, providing high patient satisfaction outcomes. Total knee prostheses are generally composed by a femoral component articulating on a polyethylene insert and a tibial tray.

Recently there has been particular attention on the component material; traditionally femoral components are made of cobalt alloys while tibial baseplates are made, in the great majority of cases, of metallic materials, but also polyethylene versions are available. There has been a degree of acceptance in some countries that metal related pathology may exist as demonstrated by the Australian Arthroplasty register where metal hypersensitivity was reported as the fifth most common cause for revision hip arthroplasty 2012 report, making up for 5.9% of all revisions. The wording was subsequently changed from "metal sensitivity" to "metal related pathology" in the 2014 report with 0.5% of all revision total hip arthroplasties (THA) associated with this term. The same change in terminology was used for TKA with metal sensitivity as a cause for revision in 1.3% of revisions in 2012 and in 2014, 1.8% of revision TKAs attributed to "metal related pathology" . The overall revision rate was 3.45% after 10 years in 396.472 TKAs, suggesting a revision rate of 0.06-0.32% secondary to metal or cement allergies. Up to today there is no question that metallic implants may generate wear debris that cause local reactions. This local reaction is not dose related nor predictable and therefore not purely due to the toxic effect of the debris but possibly due to an immunological host process. Hypersensitivity to metal undoubtedly exists but it cannot be stated at the moment to be an allergic reaction. To prevent issues arising due to metal related pathology, alternative solutions to conventional chrome cobalt material have been proposed, for example ceramic component or implant coating. In particular, TiNbN coating has been proposed by most companies thanks to its excellent biological properties. Preclinical studies have showed a high scratch resistance and low coefficient of friction, more resistance to fretting corrosion, reduction of wear, lower ion release rates and low fatigue cycle, as described in the review of Hove. Clinically, cohort of studies of TiN-coated implants showed an overall survival exceeding 90% with a follow-up of 15 to 77 months and good clinical outcomes. No reports of adverse effects related to TiN coating of CoCrMo knee implants have been showed. There are few studies that compared TiN-coated implants with the same uncoated version. Thienpont, comparing TiN-coated and uncoated CoCrMo implants, showed similar clinical and radiological outcomes at short-term follow up in both patients groups .

Overall we can conclude that in literature no adverse events have been reported concerning the TiNbN coating and in particular it has been showed that the coating doesn't not affect the performance of the device if compared with the same uncoated version.

The aim of this study is to evaluate the long term clinical and radiological performance of GMK Sphere total knee component, coated version.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 155
• Est. completion date: December 5, 2033
• Est. primary completion date: February 5, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Those older than 18 years old at the surgery time

• those suitable to undergo to a primary total knee arthroplasty for whom the GMK Sphere TiNb coated device will be implanted (according to the label indication/contraindications)

• Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to patient's surgery

Exclusion Criteria:

• Those patients with metal implants containing Co, Cr and / or Ni

• Those patients who have had environmental or occupational exposure to toxic metals such as Co, Cr and / or Ni (solvents, industrial paints, welders)

• Those whose mental conditions may compromise their ability to provide informed consent to study participation, ability to complete questionnaires or complete 10-year follow-ups

• Those unable to give their consent to participate in the study or who do not want to participate

• Any condition not mentioned in inclusion criteria.

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Diagnostic Test:
• blood sample
preoperative and at 6 months and 1 year follow-up after the surgery the patients will take a blood sample

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi di Milano Sede di via Monreale18 (Istituto Clinico San Siro)	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Medacta International SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term performance	Device survival will be assessed by Kaplan Maier curve	10 years
Secondary	Clinical performance	Clinical performance will be assessed through the NEW KSS score collected during preoperative and follow-up visits. The score is divided in subscale: objective (0-75), Symptoms (0-25), Satisfaction (0-40), Expectation (0-15), Functional Activities (0-30), high scores indicating good outcomes.	6 months, 1, 5 and 10 years after surgery
Secondary	Radiological performance	standard x-ray exam performed preoperatively and postoperatively before discharge from hospital and during follow-up visits	(1, 5 and 10 years after surgery
Secondary	Retropatellar pain	Kujala score collected during preoperative visit and follow-up visit. Each scale ranges from 0 to 100 with high scores indicating good outcomes.	6 months and 1, 5 and 10 years after surgery
Secondary	Ion release rate	blood level of ions Co, Cr and Ni in a subgroup of 30 patients	preoperative, 6 months and 1 year visits
Secondary	Activity level after surgery	UCLA Activity score collected during preoperative visit and follow-up visit. 1-10 scale with 1 less active, to 10 more active.	6 months and 1year after surgery
Secondary	Rate of complications	collection of all adverse events occurred	up to 10 years after surgery