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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06354543
Other study ID # CA01-TK-ARTHRO
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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