Arthroplasty Cements Outcomes - A Post-market Follow-up

Arthroplasty Clinical Trial

Official title:

Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06354543
• Other study ID #: CA01-TK-ARTHRO
• Status: Recruiting
• Start date: December 16, 2020
• Est. completion date: December 2045

Study information

• Verified date: April 2024
• Source: Teknimed
• Contact: Solange VAN DE MOORTELE, PhD
• Phone: +33 5 34 25 26 79
• Email: s.vandemoortele[@]teknimed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all Teknimed Arthroplasty range of products: CEMFIX® and GENTAFIX® bone cements families and CEMSTOP® cement restrictor, and all their private labels. Teknimed bone cements and cement restrictor are legacy products, some marketed for more than 20 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a "real-life" setting. The study is a retrospective and prospective global, single arm, non-controlled, multicentric, ambispective observational study. Patients will be followed as per local standard medical care of the site.

Description:

It is admitted that: - Joint replacement is a commonly performed major surgical procedure that has considerable success in alleviating pain and disability; - These procedures may be done with the help of a bone cement (PMMA) to fix the prosthesis to the bone (cemented fixation); - Most common reasons for primary joint replacement are osteoarthritis, osteonecrosis and trauma; - Most common reasons for revision of joint replacement are dislocation, infection, fracture and prothesis loosening; - Quality of bone cement have a large influence on long-term implant stability. TEKNIMED has developed several bone cements and a cement restrictor currently used in arthroplasty procedures. With the increasing use of these procedures, there is a need of real-life long-term safety and efficacy data on the bone cements. This retro- and prospective study is performed to assess the safety and performance of TEKNIMED arthroplasty products in their current clinical use.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: December 2045
• Est. primary completion date: December 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be 18 years or older.
• Be willing to sign an informed consent approved by Institutional Review Board (IRB) or European Commission (EC) (when applicable) or not oppose to the use of their clinical data in the study
• For prospective inclusion: be considered for an arthroplasty procedure with one of the TEKNIMED orthopaedic cement and/or cement restrictor comprised in this study (primary or revision surgery).
• For retrospective inclusion: have undergone a primary or revision arthroplasty procedure with a TEKNIMED orthopaedic cement and/or cement restrictor between the 1st January 2016 and the date of the site initiation visit (SIV).
• Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (where applicable).

Exclusion Criteria:

• Patient under trusteeship or guardianship,
• Women who are pregnant
• Patient unable to follow the protocol
• Patient whose vital prognosis is unfavorable (according to investigator's opinion)

Related Conditions & MeSH terms

• Arthroplasty

Intervention

Device:
• Cemented joint arthroplasty
Joint replacement with cemented prosthetic components

Locations

Country	Name	City	State
France	Clinique du Vivarais	Aubenas	Auvergne-rhône-alpes
France	Clinique du Dr Henri Guillard	Coutances	Normandie
France	Clinique du Val d'Ouest	Ecully	Auvergne-rhône-alpes
France	Cabinet de consultation	Evreux	Eure
France	Hôpital Européen Marseille	Marseille	Provence-alpes-cote D'azur
France	Clinique de l'Atlantique	Puilboreau	Nouvelle-aquitaine
Italy	Instituto Ortopedico Rizzoli	Bologna	Émilie-Romagne
Italy	Ospedale Santissima Annunziata	Cento	Emilie-Romagne

Sponsors (1)

Lead Sponsor	Collaborator
Teknimed

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.	15 years (until the lifetime of the device)
Primary	Superficial and/or deep postoperative infection rate.	In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.	15 years (until the lifetime of the device)
Secondary	Pain Level	Pain evaluated by Visual Analogue Scale (VAS): on a scale of 0 to 10, with 0 being no pain and 10 being the most severe pain at the Baseline and at the Follow-up visits	5 years
Secondary	Patients' satisfaction	Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits	5 years
Secondary	Restoration of function	Evaluation of mobility by functional scores: "Constant Score" for the shoulder (scale of 100 points, 100 points is the best mobility) at the baseline and at the Follow-up visits	5 years
Secondary	Evaluation of function and radiological outcomes	"SEDEL Score" at the Follow-up visits ( A: no pejorative functional and radiographic signs / B: patients with stable clinical result but demonstrating progressively evolving radiographic alterations / C: patients with deteriorating functional score but lack of any radiographic explanation / D: patients with bad clinical score associated with progressive radiographic deterioration)	5 years
Secondary	Complications rate	Evaluation of complications will be assessed on radiological images: cement leakage, implant migration, radiolucent lines, osteolytic zone at the Follow-up visits	5 years
Secondary	Antalgic consumption	Antalgic consumption and the drug type at the Baseline and at the Follow-up visits	5 years
Secondary	Restoration of function	Evaluation of mobility by functional scores: "Postel Merle d'Aubigne score" (PMA) for the hip (scale of 18 points, 18 points is the best functional score) at the Baseline and at the Follow-up visits	5 years
Secondary	Restoration of function	Evaluation of mobility by functional scores: "Tegner Lysholm Knee Score" for the knee (scale of 100 points, 100 points is the best functional score) at the Baseline and at the Follow-up visits	5 years
Secondary	Adverse events	All adverse events (such as prosthesis loosening rate, dislocation, deep infection …) occured during surgery and through study completion	15 years (until the lifetime of the device)