A randomised clinical trial comparing minimal invasive (MIS) total knee replacement (TKR) with conventional total knee replacement

A randomised clinical trial comparing minimal invasive (MIS) total knee replacement (TKR) with conventional total knee replacement - MIS versus conventional TKR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35423

Enrollment

100

Registered

2007-05-30

Start date

2007-08-20

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

osteoarthrosis worn out knee

Interventions

Intervention: Placement of an cemented primary total knee replacement with a conventional incision or with a minimal invasive approach. Amendement 1: CT scan

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: osteoarthrosis

Exclusion criteria

Exclusion criteria: unwilling to participate

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: Outcome will be clinically measured using the Knee Society Score (KSS), Oxford knee score, SF-12, KOOS questionnaire, whilst radiographic outcomes will be evaluated through standard radiographic parameters. Discharge criteria will be checked at day 3 p.o. Amendement 1: Penetration dept and wide of bone cement	—

Secondary

Measure	Time frame
Hb level day 3 Walking stairs (one level) Transfers Pain VAS / medication cement penetration research	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)