Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a long term follow-up of a randomized controlled clinical trial

Retention of the posterior cruciate ligament versus the posterior stabilized design in total knee arthroplasty: a long term follow-up of a randomized controlled clinical trial - Long term follow-up: retention versus sacrifice of the PCL in TKA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49929

Enrollment

Registered

2021-09-22

Start date

2021-10-06

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

osteoarthrosis of the knee joint

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who participated in the previous randomized controlled trial (registration number: 2007-23; abr number: NL 16071.056.07; NTR 1673)

Exclusion criteria

Exclusion criteria: - deceased - no known contact address - reasons to believe that the patient is not capable - e.g. because of cognitive reasons * to fill out the questionnaires - revision surgery of the index knee (except for revision of the patella)

Design outcomes

Primary

Measure	Time frame
Patients perceived outcome after TKA as determined using the WOMAC questionnaire (0-100, higher score indicating less symptoms). The WOMAC is the most frequently used and recommended questionnaire to determine outcome after TKA (Bellamy et al, 1988). The Dutch version has proven to be reliable and valid (Roorda et al, 2004).	—

Secondary

Measure	Time frame
Secondary outcome measures in this trial are: - Active Range of motion (degrees), including flexion and extension using a goniometer - Knee Society Clinical Rating System (KSS score) as a physician-based outcome score after TKA. 0-100, higher score indicating better functioning) (Insall et al, 1989) - Quality of Life as determined with the Short Form 36 (SF-36) (0-100, higher score indicating better health) (Aaronson et al, 1998) - Kujala score to determine the presence of patellofemoral pain (0 to 100, higher scores indicate less disability) (Kievit et al, 2013) - Iwano classification, as a measure of the patellofemoral OA (scale 1-4) (Iwano et al, 1990) - Satisfaction question (5 point Likert scale) - Survival rate - Complications	—

Measure

Time frame

Secondary outcome measures in this trial are: - Active Range of motion (degrees), including flexion and extension using a goniometer - Knee Society Clinical Rating System (KSS score) as a physician-based outcome score after TKA. 0-100, higher score indicating better functioning) (Insall et al, 1989) - Quality of Life as determined with the Short Form 36 (SF-36) (0-100, higher score indicating better health) (Aaronson et al, 1998) - Kujala score to determine the presence of patellofemoral pain (0 to 100, higher scores indicate less disability) (Kievit et al, 2013) - Iwano classification, as a measure of the patellofemoral OA (scale 1-4) (Iwano et al, 1990) - Satisfaction question (5 point Likert scale) - Survival rate - Complications

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Countries

Netherlands

Outcome results