Arthroplasty Cements Outcomes - A Post-market Follow-up
- Conditions
- Arthroplasty
- Interventions
- Device: Cemented joint arthroplasty
- Registration Number
- NCT06354543
- Lead Sponsor
- Teknimed
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1050
- 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).
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CEMFIX1 Hip revision surgery Cemented joint arthroplasty Patients included for revision hip surgery with CEMFIX 1 CEMFIX1 Shoulder primary surgery Cemented joint arthroplasty Patients included for primary shoulder surgery with CEMFIX 1 CEMFIX1 Knee primary surgery Cemented joint arthroplasty Patients included for primary knee surgery with CEMFIX 1 GENTAFIX1 Shoulder primary surgery Cemented joint arthroplasty Patients included for primary shoulder surgery with GENTAFIX 1 GENTAFIX3MV Knee revision surgery Cemented joint arthroplasty Patients included for revision knee surgery with GENTAFIX 3MV CEMFIX1 Hip primary surgery Cemented joint arthroplasty Patients included for primary hip surgery with CEMFIX 1 CEMFIX1 Knee revision surgery Cemented joint arthroplasty Patients included for revision knee surgery with CEMFIX 1 CEMFIX3 Hip primary surgery Cemented joint arthroplasty Patients included for primary hip surgery with CEMFIX 3 CEMFIX3 Shoulder primary surgery Cemented joint arthroplasty Patients included for primary shoulder surgery with CEMFIX 3 GENTAFIX3MV Hip primary surgery Cemented joint arthroplasty Patients included for primary hip surgery with GENTAFIX 3MV CEMFIX1 Shoulder revision surgery Cemented joint arthroplasty Patients included for revision shoulder surgery with CEMFIX 1 CEMFIX3 Shoulder revision surgery Cemented joint arthroplasty Patients included for revision shoulder surgery with CEMFIX 3 GENTAFIX1 Knee revision surgery Cemented joint arthroplasty Patients included for revision knee surgery with GENTAFIX 1 GENTAFIX3 Hip primary surgery Cemented joint arthroplasty Patients included for primary hip surgery with GENTAFIX 3 CEMSTOP Hip surgery Cemented joint arthroplasty Patients included for hip surgery with CEMSTOP CEMFIX3 Hip revision surgery Cemented joint arthroplasty Patients included for revision hip surgery with CEMFIX 3 GENTAFIX1 Knee primary surgery Cemented joint arthroplasty Patients included for primary knee surgery with GENTAFIX 1 GENTAFIX1 Hip primary surgery Cemented joint arthroplasty Patients included for primary hip surgery with GENTAFIX 1 GENTAFIX3MV Hip revision surgery Cemented joint arthroplasty Patients included for revision hip surgery with GENTAFIX 3MV GENTAFIX3 Knee revision surgery Cemented joint arthroplasty Patients included for revision knee surgery with GENTAFIX 3 GENTAFIX3 Hip revision surgery Cemented joint arthroplasty Patients included for revision hip surgery with GENTAFIX 3
- Primary Outcome Measures
Name Time Method Survival rate 15 years (until the lifetime of the device) Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.
Superficial and/or deep postoperative infection rate. 15 years (until the lifetime of the device) In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.
- Secondary Outcome Measures
Name Time Method Adverse events 15 years (until the lifetime of the device) All adverse events (such as prosthesis loosening rate, dislocation, deep infection ...) occured during surgery and through study completion
Evaluation of function and radiological outcomes 5 years "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)
Complications rate 5 years Evaluation of complications will be assessed on radiological images: cement leakage, implant migration, radiolucent lines, osteolytic zone at the Follow-up visits
Antalgic consumption 5 years Antalgic consumption and the drug type at the Baseline and at the Follow-up visits
Pain Level 5 years 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
Patients' satisfaction 5 years Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Restoration of function 5 years 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
Trial Locations
- Locations (10)
CH de Brive
🇫🇷Brive-la-Gaillarde, Aquitaine, France
MIROUSE
🇫🇷Boujan-sur-Libron, Occitanie, France
Clinique du Vivarais
🇫🇷Aubenas, Auvergne-rhône-alpes, France
Clinique du Val d'Ouest
🇫🇷Ecully, Auvergne-rhône-alpes, France
Cabinet de consultation
🇫🇷Evreux, Eure, France
Clinique du Dr Henri Guillard
🇫🇷Coutances, Normandie, France
Clinique de l'Atlantique
🇫🇷Puilboreau, Nouvelle-aquitaine, France
Hôpital Européen Marseille
🇫🇷Marseille, Provence-alpes-cote D'azur, France
Ospedale Santissima Annunziata
🇮🇹Cento, Emilie-Romagne, Italy
Instituto Ortopedico Rizzoli
🇮🇹Bologna, Émilie-Romagne, Italy