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A Cement Compression Device for cemented TKA

A Cement Compression Device for cemented TKA - CDCS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49376
Enrollment
34
Registered
2019-10-22
Start date
2020-01-23
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 osteoarthritis knee wear

Interventions

use of the cement compression device during cementation of a total knee arthroplasty

Sponsors

Reinier Haga Orthopedisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Non-inflammatory degenerative joint disease (NIDJD), e.g. osteoarthritis, avascular necrosis - Traumatic arthritis - The need for a tibia component size 4, 5, or 6 (NexGen Legacy, Zimmerbiomet) during surgery Patients must additionally meet all of the following criteria: - Age > 18 years - Patient is willing to participate - Patient is able to speak and write Dutch - Patient qualifies for TKP based on medical history and physical examination - Patient is able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: - Rheumatoid arthritis or other forms of inflammatory disease - Uncooperative patient or patient with neurologic disorders who are incapable of following directions - Insufficient bone stock to provide adequate support and/or fixation to the prosthesis - Metabolic disorders which may impair bone formation - Osteomalacia - Charcot's disease - Previous knee surgery except arthroscopy

Design outcomes

Primary

MeasureTime frame
The main study parameters are the penetration and distribution of the cement into the bone of the proximal tibia, measured with CT.

Secondary

MeasureTime frame
The secondary parameter is the measured operation time.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)