Arthroplasty Cements Outcomes - A Post-market Follow-up

Teknimed1,050 enrolled

Overview

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: * 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.

Study Type

OBSERVATIONAL

Enrollment

1,050

Conditions

Arthroplasty

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (10)

CH de Brive

Brive-la-Gaillarde, Aquitaine, France

RECRUITING

Clinique du Vivarais

Aubenas, Auvergne-Rhône-Alpes, France

RECRUITING

Clinique du Val d'Ouest

Écully, Auvergne-Rhône-Alpes, France

RECRUITING

Cabinet de consultation

Évreux, Eure, France

RECRUITING

Clinique de l'Atlantique

Puilboreau, New Aquitaine, France

RECRUITING

Clinique du Dr Henri Guillard

Coutances, Normandy, France

RECRUITING

MIROUSE

Boujan-sur-Libron, Occitanie, France

RECRUITING

Hôpital Européen Marseille

Marseille, Provence-Alpes-Côte d'Azur Region, France

RECRUITING

Instituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, Italy

RECRUITING

Ospedale Santissima Annunziata

Cento, Emilia-Romagna, Italy

RECRUITING

Outcomes

Primary Outcomes

Survival rate

Prosthesis survival defined as time from implantation to revision surgery due to a cement defect.

Time frame: 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.

Time frame: 15 years (until the lifetime of the device)

Secondary Outcomes

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

Time frame: 5 years

Patients' satisfaction

Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 5 years

Antalgic consumption

Antalgic consumption and the drug type at the Baseline and at the Follow-up visits

Time frame: 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

Time frame: 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

Time frame: 5 years

Adverse events

All adverse events (such as prosthesis loosening rate, dislocation, deep infection …) occured during surgery and through study completion

Time frame: 15 years (until the lifetime of the device)

Arthroplasty Cements Outcomes - A Post-market Follow-up

Overview

Conditions

Interventions

Eligibility

Locations (10)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts