The ATtune Knee Outcome Study: prospective evaluation of a novel uncemented rotating platform knee system

The ATtune Knee Outcome Study: prospective evaluation of a novel uncemented rotating platform knee system - ATKOS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55973

Enrollment

900

Registered

2020-01-17

Start date

2020-02-03

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Interventions

The only difference with standard care is uncemented fixation of the prosthesis. Patients normally receive a cemented prosthesis in our institution (Spaarne Gasthuis), in other participating institut

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: End-stage osteoarthritis of the knee warranting joint replacement therapy. Capability and willingness to sign informed consent and comply with follow-up procedures. Age between 21-90 years. Capable enough in Dutch or English to be able to understand study procedures

Exclusion criteria

Exclusion criteria: An a-priori risk for a posterior-stabilized knee system (history of patellectomy or preoperative flexion limitation

Design outcomes

Primary

Measure	Time frame
Survival rate and complication rate associated with the ATTUNE knee system.	—

Secondary

Measure	Time frame
- Patient Reported Outcome Measures (PROMS), which are the 'Forgotten Joint Score 12' and the 'Kujala Anterior Knee Pain Scale' for the current study. - Physical function and return to sports, which is measured with 'Performance Based Measurments' (PBM) and 2 1-question questionnaires (Tegner and UCLA activity rating scale) - Return to work is assessed by a short self-composed questionnaire, which evaluates what kind of work the patients do, when they started after surgery and whether this is the same as their preoperative job. - A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia. - Psychologic factors are assessed with 3 questionnaires preoperative, 5 years and 10 years postoperative (Pain Self Efficacy Questionnaire (PSEQ); Patient Health Questionnaire (PHQ-2); Pain Catastrophizing Scale (PCS))	—

Measure

Time frame

- Patient Reported Outcome Measures (PROMS), which are the 'Forgotten Joint Score 12' and the 'Kujala Anterior Knee Pain Scale' for the current study. - Physical function and return to sports, which is measured with 'Performance Based Measurments' (PBM) and 2 1-question questionnaires (Tegner and UCLA activity rating scale) - Return to work is assessed by a short self-composed questionnaire, which evaluates what kind of work the patients do, when they started after surgery and whether this is the same as their preoperative job. - A long-leg radiograph is performed 1 year after surgery to assess mechanical alignment of the prosthesis with consideration of femur and tibia. - Psychologic factors are assessed with 3 questionnaires preoperative, 5 years and 10 years postoperative (Pain Self Efficacy Questionnaire (PSEQ); Patient Health Questionnaire (PHQ-2); Pain Catastrophizing Scale (PCS))

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)