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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.
It is admitted that:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEMFIX1 Knee primary surgery | Patients included for primary knee surgery with CEMFIX 1 |
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| CEMFIX1 Knee revision surgery | Patients included for revision knee surgery with CEMFIX 1 |
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| CEMFIX1 Hip primary surgery | Patients included for primary hip surgery with CEMFIX 1 |
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| CEMFIX1 Hip revision surgery | Patients included for revision hip surgery with CEMFIX 1 |
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| CEMFIX1 Shoulder primary surgery | Patients included for primary shoulder surgery with CEMFIX 1 |
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| CEMFIX1 Shoulder revision surgery | Patients included for revision shoulder surgery with CEMFIX 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cemented joint arthroplasty | Device | Joint replacement with cemented prosthetic components |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patients' satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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Patients for whom a cemented arthroplasty surgery is indicated
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Solange VAN DE MOORTELE, PhD | Contact | +33 5 34 25 26 79 | s.vandemoortele@teknimed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH de Brive | Recruiting | Brive-la-Gaillarde | Aquitaine | 19100 | France |
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| CEMFIX3 Hip primary surgery | Patients included for primary hip surgery with CEMFIX 3 |
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| CEMFIX3 Hip revision surgery | Patients included for revision hip surgery with CEMFIX 3 |
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| CEMFIX3 Shoulder primary surgery | Patients included for primary shoulder surgery with CEMFIX 3 |
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| CEMFIX3 Shoulder revision surgery | Patients included for revision shoulder surgery with CEMFIX 3 |
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| GENTAFIX1 Knee primary surgery | Patients included for primary knee surgery with GENTAFIX 1 |
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| GENTAFIX1 Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 1 |
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| GENTAFIX1 Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 1 |
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| GENTAFIX1 Shoulder primary surgery | Patients included for primary shoulder surgery with GENTAFIX 1 |
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| GENTAFIX3MV Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 3MV |
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| GENTAFIX3MV Hip revision surgery | Patients included for revision hip surgery with GENTAFIX 3MV |
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| GENTAFIX3MV Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 3MV |
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| GENTAFIX3 Knee revision surgery | Patients included for revision knee surgery with GENTAFIX 3 |
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| GENTAFIX3 Hip primary surgery | Patients included for primary hip surgery with GENTAFIX 3 |
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| GENTAFIX3 Hip revision surgery | Patients included for revision hip surgery with GENTAFIX 3 |
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| CEMSTOP Hip surgery | Patients included for hip surgery with CEMSTOP |
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Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
| 5 years |
| 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 |
| 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 |
| 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 |
| Antalgic consumption | Antalgic consumption and the drug type at the Baseline and at the Follow-up visits | 5 years |
| 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 |
| 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 |
| 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) |
| Clinique du Vivarais | Recruiting | Aubenas | Auvergne-Rhône-Alpes | 07200 | France |
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| Clinique du Val d'Ouest | Recruiting | Écully | Auvergne-Rhône-Alpes | 69130 | France |
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| Cabinet de consultation | Recruiting | Évreux | Eure | 27000 | France |
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| Clinique de l'Atlantique | Recruiting | Puilboreau | New Aquitaine | 17138 | France |
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| Clinique du Dr Henri Guillard | Recruiting | Coutances | Normandy | 50200 | France |
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| MIROUSE | Recruiting | Boujan-sur-Libron | Occitanie | 34760 | France |
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| Hôpital Européen Marseille | Recruiting | Marseille | Provence-Alpes-Côte d'Azur Region | 13003 | France |
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| Instituto Ortopedico Rizzoli | Recruiting | Bologna | Emilia-Romagna | 40136 | Italy |
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| Ospedale Santissima Annunziata | Recruiting | Cento | Emilia-Romagna | 44042 | Italy |
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