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NCT Number: NCT06354543

Arthroplasty Cements Outcomes - A Post-market Follow-up

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.

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Key information

Conditions

Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH de Brive, Brive-la-Gaillarde, Aquitaine, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cemented joint arthroplasty

Device

Joint replacement with cemented prosthetic components

Primary outcomes

  1. Survival rate

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

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

  2. Superficial and/or deep postoperative infection rate.

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

    In the case of cements with gentamicin, superficial and/or deep postoperative infection rate.

Secondary outcomes

  1. Pain Level

    Time frame: 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

  2. Patients' satisfaction

    Time frame: 5 years

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

  3. Restoration of function

    Time frame: 5 years

    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

  4. Evaluation of function and radiological outcomes

    Time frame: 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)

  5. Complications rate

    Time frame: 5 years

    Evaluation of complications will be assessed on radiological images: cement leakage, implant migration, radiolucent lines, osteolytic zone at the Follow-up visits

  6. Antalgic consumption

    Time frame: 5 years

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

  7. Restoration of function

    Time frame: 5 years

    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

  8. Restoration of function

    Time frame: 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

  9. Adverse events

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Solange VAN DE MOORTELE, PhD

CONTACT

[email protected]

+33 5 34 25 26 79

Sponsors and collaborators

Lead sponsor

Teknimed

Industry

Registry information

Official study title

Safety and Clinical Performance Assessment of Bone Cements and Cement Restrictor Used in Arthroplasty - A Post-market Clinical Follow-up

Important dates

Study start
2020
Primary completion
2035
Study completion
2045
First posted
Apr 9, 2024
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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