Arthroplasty Cements Outcomes - A Post-market Follow-up
ConditionArthroplasty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTeknimed
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial population
Patients for whom a cemented arthroplasty surgery is indicated
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Cemented joint arthroplasty
DeviceJoint replacement with cemented prosthetic components
Treatment groups
1,050 Participants
are divided into 21 treatment groups21
Treatment groupsSee each treatment group below.
Group A: CEMFIX1 Knee primary surgery1 intervention
Group B: CEMFIX1 Knee revision surgery1 intervention
Group C: CEMFIX1 Hip primary surgery1 intervention
Group D: CEMFIX1 Hip revision surgery1 intervention
Group E: CEMFIX1 Shoulder primary surgery1 intervention
Group F: CEMFIX1 Shoulder revision surgery1 intervention
Group G: CEMFIX3 Hip primary surgery1 intervention
Group H: CEMFIX3 Hip revision surgery1 intervention
Group I: CEMFIX3 Shoulder primary surgery1 intervention
Group J: CEMFIX3 Shoulder revision surgery1 intervention
Group K: GENTAFIX1 Knee primary surgery1 intervention
Group L: GENTAFIX1 Knee revision surgery1 intervention
Group M: GENTAFIX1 Hip primary surgery1 intervention
Group N: GENTAFIX1 Shoulder primary surgery1 intervention
Group O: GENTAFIX3MV Hip primary surgery1 intervention
Group P: GENTAFIX3MV Hip revision surgery1 intervention
Group Q: GENTAFIX3MV Knee revision surgery1 intervention
Group R: GENTAFIX3 Knee revision surgery1 intervention
Group S: GENTAFIX3 Hip primary surgery1 intervention
Group T: GENTAFIX3 Hip revision surgery1 intervention
Group U: CEMSTOP Hip surgery1 intervention
Trial outcomes
Primary outcomes
1
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)2
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
1
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 years2
Patients' satisfaction
Patient satisfaction assessed using a 3-question patient satisfaction questionnaire (Yes/No/Without opinion) at the Follow-up visits
Time frame
5 years3
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 years4
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 Source ClinicalTrials.gov