Volumetric Wear Measurements in Total Knee Arthroplasty; Cross-linked versus Standard Polyethylene insert

Volumetric Wear Measurements in Total Knee Arthroplasty; Cross-linked versus Standard Polyethylene insert - Cross-linked PE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34654

Enrollment

Registered

2011-01-13

Start date

2011-06-09

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Osteoarthritis of the knee

Interventions

Intervention will be Total Knee Replacement.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Osteoarthrits; Age 40-70; ASA 1 or 2.

Exclusion criteria

Exclusion criteria: Insufficient femoral or tibial bone stock Body mass index > 35 history of major non-arthroscopic surgery to the study knee active local or systemic infection Grade 3 collateral ligament insufficiency Knee Flexion 20 degrees Varus or valgus deformity > 20 degrees Rheumatoid arthritis, autoimmune disorder or immunosuppressive disorder.

Design outcomes

Primary

Measure	Time frame
Amount of wear of the insert in mm3 and mm/year (volumetric wear and linear wear)	—

Secondary

Measure	Time frame
Knee function and pain by means of the Knee Society Score, The UCLA activity score and the KOOS (Knee osteoarthritis and outcome score).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)