Freedom through constraint? A randomized clinical trial on posterior stabilization in mobile bearing total knee arthroplasty

Freedom through constraint? A randomized clinical trial on posterior stabilization in mobile bearing total knee arthroplasty - Posterior stabilized versus mobile bearing total knee arthroplasty

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49018

Enrollment

Registered

2020-04-24

Start date

2020-07-16

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

knee replacement Total knee arthroplasty

Interventions

The study group will receive the Advanced Coated System (ACS) mobile bearing posterior stabilized knee system and the control group will receive the ACS mobile bearing (non-stabilized) knee system.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age between 18-80 years - BMI

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

Design outcomes

Primary

Measure	Time frame
The main study parameter is range of motion, measured on a short-leg radiograph, of the operated knee 1 year postoperative.	—

Secondary

Measure	Time frame
Other measurements of range of motion (goniometer) and patient reported outcome measures (KOOS; NRS pain and satisfaction; EQ5D; FJS-12)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)