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Freedom Through Constraint?

Freedom through constraint? A randomized clinical trial on the role of posterior stabilization in mobile bearing total knee arthroplasty on flexion.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25318
Enrollment
56
Registered
2020-06-16
Start date
2020-06-16
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

End-stage osteoarthritis of the knee joint requiring total knee replacement

Interventions

All patients that are enrolled in the current study are receiving the cemented Advanced Coated System ® (ACS) mobile bearing total knee device (Implantcast GmbH, Buxtehude, Germany). These implants ar

Sponsors

Xpert Orthopedie
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age 18-80 years - BMI < 35 - Planned for Total knee Arthroplasty for end-stage knee osteoarthritis. - Stable health, suitable for surgery, willing and able to participate in the follow-up program. - Understanding of Dutch/English language. - Written and signed Informed Consent

Exclusion criteria

Exclusion criteria: - Revision of unicondylar or previous total knee arthroplasty - Skeletal immaturity - Charcot joints - Patellar resurfacing and/or placement of a patellar prosthesis - Previous high tibial osteotomy - Rheumatoid arthritis - Inability to complete the exercises due to contralateral knee osteoarthritis/arthroplasty or hip osteoarthritis/arthroplasty - Previous arthrofibrosis or pre-operative flexion <90? - Unable (due to mental and/or cognitive comorbidities) or unwilling to cooperate in the follow¬-up program

Design outcomes

Primary

MeasureTime frame
The main study parameter is range of motion, measured on a long-leg radiograph, of the operated knee 1 year postoperative.

Secondary

MeasureTime frame
Secondary outcome variable are: - Knee Osteoarthriitis Outcome Score (KOOS) - EuroQol 5-Dimensional (EQ5D) - Numeric Rating Scale (NRS) for pain - Numeric Rating Scale (NRS) for satisfaction - Forgotten Joint Score (FJS-12)

Contacts

Public ContactD. Haverkamp

Xpert Orthopedie

d.haverkamp@xpertorthopedie.nl088-7785205

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)